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MEDICINAL PRODUCTS FOR HUMAN USE Search

Good ManufacturingPractices - Major developments11/05/2015 Responses to the public consultation on the revision of Annex 15: Qualification andValidation.

AESGP - Association of the European Self-Medication Industry (195 KB)

Allergy Therapeutics (110 KB)

APIC - Active Pharmaceutical Ingredients Committee (201 KB)

aqpa - Austrian Qualified Person Association (126 KB)

BCGA - British Comressed Gas Association (209 KB) Press Videos

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Go back to Medicinal products for human use Quality of medicines developements

30 April 2015e-newsletter

Getting Expert help in making effective investments in health

European Commission DG Health and Food Safety Public health Medicinal products for human use

Quality of medicines developements

European CommissionPublic health

About this site Legal notice Contact Search English (en)

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Cleaning Validation Technologies (176 KB)

Dr. V. K. Bhalla (80 KB)

EALTH : European Association for Logistics and Transportation in Healthcare.(43 KB)

ECA Fondation (288 KB)

EEA - Euroean Express Association (372 KB)

EFPIA - European Federation of Pharmaceutical Industries and Associations(373 KB)

EGA - European Generic Medicines Association (221 KB)

EIPG - European Industrial Pharmacists Group (235 KB)

GE Healthcare Life Sciences (291 KB)

German Expert Group 10 "Qualification/Validation" (241 KB)

Gilead Sciences Ltd. (135 KB)

Dr. Aidan Harrington (270 KB)

IFAH - Europe-Animal Health Industry (159 KB)

ISPE - International Society for Pharmaceutical Engineering (116 KB)

Leem - Les Entreprises du Médicament (694 KB)

Lithuania - Ministry of Health (2 MB)

Mallet, Jean-Denis - Docteur en pharmacie, ancien inspecteur (55 KB)

Norgine Limited (112 KB)

Orion Corporation (98 KB)

PDA - Parenteral Drug Association (179 KB)

Pharma Systems International (UK) Ltd (125 KB)

PHARMIG - Association of the Austrian pharmaceutical industry (121 KB)

PM Group (17 KB)

Recipharm Stockholm AB (115 KB)

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Sanyuan, Luo (82 KB)

Shire (54 KB)

Soares, João (113 KB)

Stallergenes (446 KB)

Swissmedic, Swiss Agency for Therapeutic Products (510 KB)

UPIP-VAPI - Vereniging der Apothekers van de Pharmaceutische Industrie/Uniondes Pharmaciens de l’Industrie Pharmaceutique (254 KB)

31/03/2015Eudralex Volume 4,

Annex 15 A new version of Annex 15 (95 KB) has been published. This version will becomeoperational on 1 October 2015.

New guidelines publishedThe guidelines on the formalised risk assessment for ascertaining the appropriategood manufacturing practice for excipients of medicinal products for human use havebeen published. A risk assessment as set out in these guidelines should be carriedout for excipients for authorised medicinal products for human use by 21 March 2016.

The guidelines on principles of Good Distribution Practice of active substances formedicinal products for human use have also been published and come into operationon 21 September 2015.

EudraLex Volume 4 >>>

06/02/2014Revision of European Commission Guidelines on Good Manufacturing Practice forMedicinal ProductsToday the European Commission has launched the public consultation on the revisionof Annex 15: Qualification and Validation.

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Stakeholders are invited to comment on this draft (141 KB) by 31 May 2014 at thelatest. Comments should be sent by e-mail to: ADM-GMDP@ema.europa.eu and sanco-pharmaceuticals-D6@ec.europa.eu.

Please consult the privacy statement on this consultation (82 KB).

28/11/2013Responses to the public consultation on the revision of Annex 16: Certification by aQualified Person and Batch Release.

AEFI - Spanish Association of Pharmacists in Industry (345 KB)

AESGP - Association of the European Self-Medication Industry (122 KB)

APIC - Active Pharmaceutical Ingredients Committee (196 KB)

AQPA - Austrian Qualified Person Association (122 KB)

BPI - German Pharmaceutical Industry Association e.V (19 KB)

CEVA Phylaxia Veterinary Biologicals Co. Ltd (285 KB)

CQI - PQG -Pharmaceutical Quality Group of the Chartered Quality Institute (140KB)

EAEPC - European Association of Euro-Pharmaceutical Companies (627 KB)

EFPIA - European Federation of Pharmaceutical Industries and Associations(261 KB)

EGA - European Generic Medicines Association (106 KB)

EIGA - European Industrial Gases Association (145 KB)

EIPG - European Industrial Pharmacists Group (110 KB)

European QP Association (196 KB)

GE Healthcare Life Sciences (279 KB)

GIRP - Groupement International de la Répartition Pharmaceutique (131 KB)

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HEXAL-SANDOZ (256 KB)

IFAH - Europe-Animal Health Industry (59 KB)

ISPE - International Society for Pharmaceutical Engineering (52 KB)

Leem - Les Entreprises du Médicament (138 KB)

LFB Biotechnologies (57 KB)

Mallet, Jean-Denis - Docteur en pharmacie, ancien inspecteur : [1] (254 KB) - [2](250 KB)

MPT Pharma (183 KB)

PHARMIG - Association of the Austrian pharmaceutical industry (82 KB)

PIGA - Polish Industrial Gases Association (103 KB)

Ranbaxy Laboratories Ltd. (187 KB)

SCIENCE PHARMA Poland (143 KB)

TEVA Pharmaceuticals Europe (217 KB)

23/11/2013 A new version of the Guidelines on good distribution practice (GDP) of medicinalproducts was published todayThe revised guidelines (OJ C 343/1, 23.11.2013) correct factual mistakes insubchapters 5.5 and 6.3, give more explanations on the rationale for the revision andprovide a formal date of coming into operation. These guidelines, which replace theguidelines on GDP published in March 2013, are applicable as of 24 November 2013.

08/11/2013Responses to the public consultation on draft guidelines on the formalised riskassessment for ascertaining the appropriate good manufacturing practice forexcipients of medicinal products for human use.

AEMPS - Agencia Española de Medicamentos y Productos Sanitario (463 KB)

AESGP - Association Européenne des Spécialités Pharmaceutiques Grand Public

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(272 KB)

EFCG-European Fine Chemicals Group (444 KB)

EFPIA-European Federation of Pharmaceutical Industries (161 KB)

FECC-Europen Association of Chemical Distributors (411 KB)

GE Healthcare Medical Diagnostics (184 KB)

GENUS PHARMACEUTICALS (311 KB)

IPEC-International Pharmaceutical Excipients Council Europe (254 KB)

LEEM-Les entreprises du médicaments (237 KB)

LFB-Biomédicaments (76 KB)

MAGYOS (259 KB)

PDA-Parenteral Drug Association (117 KB)

PHARMIG-Association of the Austrian pharmaceutical industries (251 KB)

SANDOZ INTERNATIONAL GmbH (188 KB)

SCIENCE PHARMA (92 KB)

Gedeon Richter Plc., Merck & Co., Norgine and UCB Pharma SA requested that theirresponses not be published.

08/11/2013Responses to the public consultation on draft guidelines on the principles of gooddistribution practices for active substances for medicinal products for human use.

AESGP-Association Européenne des Spécialités Pharmaceutiques Grand Public(304 KB)

APIC-Active Pharmaceutical Ingredients Committee (101 KB)

CHEMO (60 KB)

DEUTSCHE POST DHL (312 KB)

EFPIA-European Federation of Pharmaceutical Industries (217 KB)

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EISAI Manufacturing Limited (62 KB)

FECC-European Association of Chemical Distributors (358 KB)

FRESENIUS-Kabi Deutschland GMBH (133 KB)

GIRP - European Association of Pharmaceutical Full-line Wholesalers (326 KB)

Glenmark Pharmaceuticals (194 KB)

ISPE - International Society for Pharmaceutical Engineering (203 KB)

LEEM - Les entreprises du médicaments (189 KB)

LifeConEx (114 KB)

MAGYOS (236 KB)

PDA - Parenteral Drug Association (192 KB)

PHARMIG - Association of the Austrian pharmaceutical industries (82 KB)

POLISH HERBAL Committee (431 KB)

QUEMACO - Chemical Marketing Company (100 KB)

RANBAXY Lab (263 KB)

SCIENCE PHARMA (75 KB)

SGAE - Secrétariat Général des Affaires Etrangères France (836 KB)

The Finnish Pharmacists’ Society (112 KB)

VDC - Drug and Chemical Association (143 KB)

White Wave - Pharmaceutical Consultancy Company (229 KB)

Yusen Logistics (UK) Ltd (138 KB)

Gedeon Richter Plc., Merck KGaA, Teva Pharmaceutical Industries Ltd. and UCBPharma SA requested that their response not be published.

08/11/2013Responses to the public consultation on revision of EU Commission guidelines onGood Manufacturing Practice Medicinal Products, Part I, Chapters 3, 5, 6 and 8.

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AESGP-Association Européenne des Spécialités Pharmaceutiques Grand Public :ch 3 (119 KB) - ch 5 (140 KB) - ch 6 (80 KB) - ch 8 (68 KB)

APIC-Active Pharmaceutical Ingredients Committee : ch 5 (173 KB)

BPI – German Pharmaceutical Industry Association : ch 3, 5, 6, 8 (211 KB) - ch 8(118 KB)

Charles River : ch 6 (176 KB)

EFPIA-European Federation of Pharmaceutical Industries : ch 3, 5 (149 KB) - ch6 (144 KB) - ch 8 (140 KB)

EIGA - The European Industrial Gases Association : ch 3, 5, 8 (53 KB)

EIGP - European Industrial Pharmacists Group : ch 3, 5, 6 (122 KB)

FDB - Fujifilm Diosynth Biotechnologies : ch 3, 5 (125 KB)

Fecc - The European Association of Chemical Distributors : ch 5 (372 KB)

GE Healthcare, Medical Diagnostics : ch 5 (114 KB) - ch 6 (109 KB) - ch 8(110 KB)

Health Science Authority of Singapore : ch 5 (279 KB)

IFAH - International Animal Health Organisation Europe : ch 3, 5, 6, 8 (119 KB)

IPEC-International Pharmaceutical Excipients Council Europe : ch 5 (204 KB)

ISPE - the International Society for Pharmaceutical Engineering : ch 3 (101 KB) -ch 5 (147 KB) - ch 8 (147 KB)

LEEM - Les entreprises du médicaments : ch 3 (112 KB) - ch 5 (146 KB) - ch6 (252 KB) - ch 8 (143 KB)

Leiter Analytik : ch 6 (82 KB)

LFB Biotechnologies : ch 6 (29 KB)Dr Jean-Denis Mallet : ch 5 (173 KB) - ch 6 (204 KB) - ch 8 (83 KB)

PDA - Parenteral Drug Association : ch 3 (126 KB) - ch 5 (106 KB) - ch 6(124 KB) - ch 8 (127 KB)

PHARMIG - Association of the Austrian pharmaceutical industries : ch 3 (157 KB)

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- ch 5 (286 KB)

Polish Industrial Pharmacists Association : ch 3 (85 KB)

Science Pharma : ch 5, 6 (232 KB)

Gedeon Richter Plc. requested that its response not be published.

05/07/2013 Revision of EU Commission guidelines on Good Manufacturing Practice for MedicinalProductsToday the European Commission launched the public consultation on the revision ofthe Annex 16: Certification by a Qualified Person and Batch Release.Stakeholders are invited to comment on this draft (150 KB) by 5 November 2013 atthe latest. Comments should be sent by email to: ADM-GMDP@ema.europa.eu andSANCO-pharmaceuticals-D6@ec.europa.eu

21/06/2013 The Unites States have been added to the "list of third countries" asregards standards of manufacture and supervision of activepharmaceutical ingredients equivalent to those of the EU. TheCommission Decision is here .

05/06/2013 Japan has been added to the "list of third countries" as regards standards ofmanufacture and supervision of active pharmaceutical ingredients equivalent to thoseof the EU. The Commission Decision is here .

25/04/2013 Australia has been added to the "list of third countries" as regards standards ofmanufacture and supervision of active pharmaceutical ingredients equivalent to thoseof the EU. The Commission Decision is here .

12/04/2013

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Importation of active substances for medicinal products for human use

Version 4.1 of the "questions and answers" document (57 KB)

06/02/2013Guidelines on the formalised risk assessment for ascertaining the appropriate goodmanufacturing practice for excipients of medicinal products for human use - draftsubmitted for public consultation (32 KB). Stakeholders are invited to comment on this draft by 30 April 2013 at the latest.Responses should be sent preferably by e-mail to sanco-pharmaceuticals-d6@ec.europa.eu, or by post to Unit SANCO/D/6, DM24 02/050, BE-1049 Brussels.

06/02/2013Guidelines on the principles of good distribution practices for active substances formedicinal products for human use - draft submitted for public consultation (45KB). Stakeholders are invited to comment on this draft by 30 April 2013 at the latest.Responses should be sent preferably by e-mail to sanco-pharmaceuticals-d6@ec.europa.eu, or by post to Unit SANCO/D/6, DM24 02/050, BE-1049 Brussels.

28/01/2013Importation of active substances for medicinal products for human use

Version 3.0 of the "questions and answers (49 KB)" document

Amended template for "written confirmation" (487 KB)

24/01/2013Commission Implementing Decision of 23 January 2013 on the assessment of a thirdcountry’s regulatory framework applicable to active substances of medicinal productsfor human use and of the respective control and enforcement activities pursuant toArticle 111b of Directive 2001/83/EC of the European Parliament and of the Council(722 KB)

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Eudralex Volume 1 >>>

24/01/2013Responses to the public consultation on a concept paper on the implementing act onthe requirements for the assessment of the regulatory framework applicable to themanufacturing of active substances of medicinal products for human use (TEVA, theFreie und Hansestadt Hamburg, and the Zentralstelle der Länder fürGesundheitsschutz bei Arzneimitteln und Medizinprodukten asked not to publish theirresponse).

Agencia Española de Medicamentos y Productos Sanitarios (448 KB)

AESGP - Association of the European Self-Medication Industry (115 KB)

APIC - Active Pharmaceutical Ingredients Committee (200 KB)

ASMI - Australian Self-Medication Industry : [1] (230 KB) - [2] (52 KB)

Bogin - Bond van de Generieke Geneesmiddelenindustrie Nederland (30 KB)

BPI - German Pharmaceutical Industries Association : [1] (50 KB) - [2] (30KB)

Brazil -Brazilian Government (52 KB)

edqm - European Directorate for the Quality of Medicines & HealthCare (369 KB)

EFCG - European Fine Chemicals Group (100 KB)

EFPIA - European Federation of Pharmaceutical Industries and Associations : [1](21 KB) - [2] (126 KB) - [3] (315 KB)

EGA - European Generic medicines Association (468 KB)

EIPG - European Industrial Pharmacists' Group (188 KB)

EUCOPE - European Confederation of Pharmaceutical Entrepreneurs (704 KB)

IPFA - International Plasma Fractionation Association (10 KB)

Japan - Mission of Japan to the European Union (13 KB)

Republic of Latvia (151 KB)

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Lonza Group Ltd. (18 KB)

H. Lundbeck (18 KB)

MHRA - Medicines and Healthcare products Regulatory Agency : [1] (87 KB) - [2](82 KB)

The Netherlands , Ministry of Health, Welfare and Sport (48 KB)

PHARMIG - The association of the Austrian pharmaceutical industry (79 KB)

PIC/S - Pharmaceutical Inspection Co-operation Scheme (98 KB)

17/01/2013Revision of EU Commission guidelines on Good manufacturing Practice MedicinalProducts

Today, the European Commission launches the public consultation of the followingrevised guidelines on good manufacturing practices:Chapter 3: Premises and Equipment (53 KB) Reasons for changes: The only change is to section 6 as part of the improved guidanceon prevention of cross-contamination involving also Chapter 5 and includes referenceto a new complementary toxicological assessment guidance.

Chapter 5: Production (84 KB) Reasons for changes: Changes have been made to sections 17 to 20 to improve theguidance on prevention of cross-contamination and to refer to toxicologicalassessment guidance. Changes were also introduced in sections 26 to 28 on thequalification of suppliers in order to reflect the legal obligation of manufacturingauthorisation holders to ensure that active substances are produced in accordancewith GMP. The changes include supply chain traceability. Section (33) is inserted toclarify and harmonise expectations of manufacturers regarding the testing of startingmaterials while section (68) introduces guidance on notification of restrictions insupply.

Chapter 6: Quality Control (62 KB)

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Reasons for changes: Inclusion of a new section on Technical transfer of testing methods and other itemssuch as out of specification results.

Chapter 8: Complaints, Quality Defects and Product Recalls (79 KB) Reasons for changes: - To reflect Quality Risk Management principles to be applied when investigating qualitydefects/complaints and when making decisions in relation to product recalls or otherrisk-mitigating actions.- To emphasise the need for the cause(s) of quality defects/complaints to beinvestigated and determined, and that appropriate preventative actions are put in placeto guard against a recurrence of the issue.- To clarify expectations and responsibilities in relation to the reporting of quality defectsto the Supervisory Authority.

Chapter 3 and 5 should be read in conjunction with the draft EMA guideline (170KB)on setting health based exposure limits for use in risk identification in themanufacture of different medicinal products in shared facilitiesComments and suggestions are invited by 18 July 2013 and should be sent by emailto: ADM-GMDP@ema.europa.eu and SANCO-pharmaceuticals-D6@ec.europa.eu

22/11/2012Commission facilitates importation of pharmaceutical active substances fromSwitzerland Switzerland has today been listed as the first third country with standards in themanufacture of active pharmaceutical ingredients equivalent to those of the EU. After asuccessful assessment, the European Commission concluded that the regulatoryframework applicable to active substances exported to the Union from Switzerland, therespective controls and the enforcement activities are equivalent to those of the Union.This means in practice that Switzerland will not have to issue a 'written confirmation' foreach consignment of active substance for medicinal product for human use importedinto the EU as of 2 July 2013. The 'written confirmation' aims at verifying that the active

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substance is manufactured in compliance with standards of good manufacturingpractices. Being listed by the European Commission or issuing a 'written confirmation'are two possible options introduced by the Falsified Medicines Directive to ascertainthe quality of imported active substances.

More information:

Commission implementing Decision (OJ L 325, 23.11.2012)

Quality of medicines and Good Manufacturing Practices (GMP)

Information leaflet (702 KB)

06/09/2012 Publication of chapter 1, chapter 7 and Annex 2 of the detailed guidelines of thegood manufacturing practices

Today, DG SANCO launches the publication of three revised guidelines:

Chapter 1 on Pharmaceutical Quality System (66 KB)is amended in order toalign with the concepts and terminology described in the ICH Q10 tripartite guidelineon Pharmaceutical Quality System. The title of the chapter itself is also changedaccordingly.

Chapter 7 on Outsourced activities (21 KB)is revised in order to provideupdated guidance on outsourced GMP regulated activities beyond the current scopeof contract manufacture and analysis operations and in view of the ICH Q10guideline on the Pharmaceutical Quality System The title of the Chapter has beenchanged to reflect this.

Annex 2 on Manufacture of Biological active substances and Medicinal Productsfor Human Use (171 KB)is revised as a consequence of the restructuring of theGMP Guide, new manufacturing technology and concepts, the increased breadth ofbiological medicinal products to include several new product types such astransgenic derived products and the Advanced Therapy Medicinal Products, (ATMPs)together with associated new legislation.

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Deadline for coming into operation: 31 January 2013

29/08/2012Responses to the concept paper submitted for public consultation concerning theDelegated act on the principles and guidelines of good manufacturing practice foractive substances in medicinal products for human useThe responses are available here.

25/07/2012New rules on importing active pharmaceutical ingredients into the EU – informationleafletAn information leaflet on the new rules on importing active pharmaceutical ingredientsinto the EU is available here (702 KB).

10/07/2012 Template for the 'written confirmation' for active substances exported to the EuropeanUnion for medicinal products for human use

Importation of active substances for medicinal products for human use - Questions andAnswers (version 1.0) (32 KB)

More information >>>

16/04/2012 Public consultation on a draft template for the written confirmation for activesubstances imported into the European Union for medicinal products for humanuse. (47 KB)

The responses are available here :

AEFI - The Spanish Association of Pharmacists in Industry (56 KB)

AEMPS - Agencia Española de Medicamentos y Productos Sanitario (511 KB)

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AESGP-Association Européenne des Spécialités Pharmaceutiques Grand Public(97 KB)

Anqiu Lu'an Pharmaceutical Co., Ltd (42 KB)

APIC - Active Pharmaceutical Ingredients Committee - [1] (151 KB) - [2] (93KB)

Chifeng Arker Pharmaceutical Technology Co., Ltd. (44 KB)

Bogin (335 KB)

China Chamber of Commerce of Import & Export (123 KB)

Domenico Criscuolo, MD, PhD, FFPM (28 KB)

Yantai Donggheng Biochemicals CO. LTD. (293 KB)

EFCG/CEFIC (93 KB)

France - Autorités françaises (18 KB)

GBP - Zhejiang Guobang Pharmaceutical Co., Ltd (100 KB)

HEC PHARM CO.,LTD (47 KB)

Hubei Biocause (41 KB)

ZHEJIANG JIUZHOU PHARMACEUTICAL CO., LTD (119 KB)

Kela NV (30 KB)

the Netherlands - Ministry of Health, Welfare and Sport (75 KB)

MHRA - Medicines and Healthcare products Regulatory Agency, UK (78 KB)

Northeast Pharmaceutical Group Co.,Ltd (93 KB)

Nycomed: a Takeda Company (53 KB)

Orchid Chemicals & Pharmaceuticals Ltd., India (31 KB)

PHARMIG-Association of the Austrian pharmaceutical industrie (88 KB)

Rambaxy (57 KB)

R L Fine Chem, BANGALORE, INDIA (60 KB)

SFDA (10 KB)

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VDC - Drug and Chemicals Association (2 MB)

Yonsung Fine Chemicals Co., Ltd. (38 KB)

Zhejiang Hisoar Pharmaceutical Co., Ltd. (50 KB)

Chongqin Pharmaceutical Research Institute, Dow Corning, Kyongbo, NKF, Qilu,Sandoz and TEVA asked not to publish their response

20/01/2012 Delegated act on the principles and guidelines of good manufacturing practice foractive substances in medicinal products for human use - concept paper submittedfor public consultation

(35 KB)

Directive 2011/62/EU places an obligation on Member States to take appropriatemeasures to ensure that manufacturers of active substances on their territory complywith good manufacturing practice ('GMP') for active substances. It also places anobligation on the Commission to adopt, by means of delegated acts, the principles andguidelines of good manufacturing practice for active substances. This concept paper

(35 KB) is being released for public consultation with a view to preparing thedelegated act on principles and guidelines of good manufacturing practice for activesubstances in medicinal products for human use.

The responses to the public consultation can be found here

7/12/2011 Implementing act on the requirements for the assessment of the regulatoryframework applicable to the manufacturing of active substances of medicinalproducts for human use - Concept paper submitted for public consultation (52KB)

Directive 2011/62/EU introduces EU-wide rules for the importation of activesubstances: According to Article 46b(2) of Directive 2001/83/EC, active substances

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shall only be imported if, inter alia, the active substances are accompanied by a writtenconfirmation from the competent authority of the exporting third country which, asregards the plant manufacturing the exported active substance, confirms that thestandards of good manufacturing practice and control of the plant are equivalent tothose in the Union. The requirement of a written confirmation is waived for thirdcountries listed by the Commission in accordance with Article 111b of Directive2001/83/EC. Article 111b(2) of Directive 2001/83/EC provides that the Commissionadopts an implementing measure to apply these requirements. This concept paper isbeing rolled out for public consultation with a view to preparing this implementing act.

10/05/2011 Publication of the revised Annex 14 of the GMP guide (50 KB) as regards themanufacture of medicinal products Derived from Human Blood or Plasma

Today, the unit in charge of pharmaceuticals launches the publication of the revisedAnnex 14 of the GMP guide on the manufacture of medicinal products Derived fromHuman Blood or PlasmaThe Annex has been revised in the light of Directive 2002/98/EC and relevantimplementing directives setting standards of quality and safety for the collection andtesting of human blood and blood components for all uses, including the manufactureof medicinal products. Deadline for coming into operation: 30 November 2011

19/11/2010 Public consultation of the revised chapter 5 of the GMP laying down the detailedguidelines for production (38 KB)

Today, DG SANCO launches a public consultation of chapter 5 of the goodmanufacturing practices (38 KB)laying down the detailed guidelines on production.Changes are proposed on the qualification of suppliers of starting material, the supplychain traceability for starting materials and the testing of starting materials.

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Comments and suggestions are invited by 28 February 2011 and should be sent byemail to: SANCO-gmp@ec.europa.euand ADM-GMDP@emea.europa.eu

9/11/2010 Public consultation of the revised chapter 7 of the GMP laying down the detailedguidelines for outsourcing activities

(18 KB)Today, DG SANCO launches a public consultation of the revised chapter 7of the good manufacturing practices on outsourced activities.Following the ICH Q10 guideline on the Pharmaceutical Quality System, Chapter 7 ofthe GMP Guide has been revised (18 KB)to provide guidance on outsourcedactivities beyond the current scope of contract manufacture and analysis operations.

Comments and suggestions are invited by 28 February 2011 and should be sent byemail to: SANCO-gmp@ec.europa.euand ADM-GMDP@emea.europa.eu

19/04/2010 Public consultation on Annex 2 of the GMP laying down the guidelines for themanufacture of biological medicinal substances and products for human use

(103 KB)Today, the unit in charge of pharmaceuticals launches a publicconsultation on Annex 2 of the good manufacturing practices laying down theguidelines for the manufacture of biological medicinal substances and products forhuman use.Annex 2 is proposed to be revised as a consequence of the restructuring ofthe GMP guide, the increased breadth of biological products to include several newproduct types such as transgenic derived products and the Advanced TherapyMedicinal Products, (ATMPs) together with associated new legislation. Significantchanges have also been made as a result of the comments received from the firstconsultation.

Comments and suggestions are invited by 15 July 2010 and should be sent by emailto: adm-gmdp@ema.europa.eu and ENTR-GMP@ec.europa.eu

04/12/2009

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Public consultation on part III of the GMP guidelines on the preparation of the sitemaster file (42 KB)

Today, the DG Enterprise launches a public consultation on part III of the goodmanufacturing practices laying down guidance to manufacturers in preparing sitemaster files.

Comments and suggestions are invited by 31 March 2010 and should be sent by emailto: ADM-GMDP@ema.europa.euand ENTR-GMP@ec.europa.eu

16/11/2009 Public consultation on chapter 1 of the GMP laying down the guidelines for QualityManagement System

Today, the DG Enterprise launches a public consultation on part I, chapter 1 of the goodmanufacturing practices laying down the guidelines on Quality Management System

(51 KB). Chapter 1 is proposed to be updated to take into account the principles of“Pharmaceutical Quality System” as described in the ICH Q10 guideline.

Comments and suggestions are invited by 18 February 2010 and should be sent byemail to: gmp@emea.europa.eu and ENTR-GMP@ec.europa.eu

16/11/2009 Public consultation on chapter 2 of the GMP laying down the guidelines forPersonnel

Today, the DG Enterprise launches a public consultation on part I chapter 2 of the goodmanufacturing practices laying down the guidelines on Personnel (17 KB). Chapter2 is proposed to be updated to take into account the principles of “PharmaceuticalQuality System” as described in the ICH Q10 guideline.

Comments and suggestions are invited by 18 February 2010 and should be sent byemail to: gmp@emea.europa.eu and ENTR-GMP@ec.europa.eu

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22/03/2007 In preparation of a Directive on GMP for certain excipients following Article 46 (f) ofDirective 2001/83/EC, as amended by Directive 2004/27/EC, DG Enterprise andIndustry asks excipient manufacturers and manufacturers/ importers of medicinalproducts for human use (excipient users) to contribute to an online consultation onpossible impacts of different policy options. Excipient distributors may also participatein this consultation. With the questionnaires for excipient manufacturers and excipientusers we also publish the draft "Specific Conditions of the Application of the Principlesand Guidelines of GMP for Certain Excipients" (23 KB) as a possible basis for aGMP Directive. Before responding, please carefully read the attached instruction note

(884 KB) . For separate comments to the draft specific GMP conditions please usethe template for comments as attached to the instruction note.

Excipient manufacturers and excipient users are asked to respond by 30 July 2007.Small and medium size enterprises are specifically encouraged to contribute to thisconsultation.

03/05/2006

GMP Annex 7 "Manufacture of Herbal Medicinal Products" : Draft revision for publicconsultation (28 KB) The annex has been revised in the light of new GMP requirements for activessubstances used as starting materials (GMP Part II). It specifies application of Part II forthe manufacture of herbal medicinal products. Additional changes are in particularrelated to the new Directive 2004/24/EC on traditional herbal medicinal products.

Public comments should be sent to sabine.atzor@ec.europa.eu andgmp@emea.eu.int by 31 July 2006.

20/12/2005 New GMP Annex 19 for Reference and Retention Samples (24 KB)

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This new annex to the GMP Guide provides guidance on the taking and holding ofreference samples of starting materials, packaging materials and finished products aswell as for retention samples of finished products. The annex provides definitions of theterms "reference sample" and "retention sample", which hitherto were often incorrectlyconsidered as synonyms. Updated guidance is also given on the size of referencesamples and a consequential change was made to Chapter 6, section 14, of the GMPGuide to maintain consistency (see News on 08/11/2005). Both the revised Chapter 6and Annex 19 will come into operation on 01 June 2006.

20/12/2005

Revised GMP Part I/ Chapter 8 on Complaints and Product Recall (18 KB) The revision was made to raise awareness of the possibility that a reported qualitydefect may be the result of counterfeiting activity and to clarify that the discovery of acounterfeit medicinal product should be reported to the competent authority. Thesechanges are in line with WHO recommendations. The revised Chapter 8 will come intooperation on 01 February 2006.

11/11/2005

Draft Amendment to Annex 1 of the GMP guide for public consultation (37 KB)(corrected version)Following a revision of Annex 1 on the manufacture of sterile medicinal products, whichwas launched in May 2003, the need for an ongoing discussion on the table providingenvironmental cleanliness and a number of other aspects to the annex were identified.The results of this discussion are reflected in the draft amendment of the guide. Publiccomments are invited on the proposal and should be sent toSabine.Atzor@ec.europa.eu and David.Cockburn@emea.eu.int before 30 April 2006.

8/11/2005

New GMP Provisions for Product Quality Review and On-going Stability Programme:Revision of GMP Guidelines, Part I Revision ofChapter 1 (23 KB) and Chapter 6

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(33 KB) Chapter 1 on Quality Management has been revised to include new requirements onProduct Quality Review and is now published in a consolidated version. The revisedchapter will come into force in January 2006. Although companies should already havemost of the information requested available, it is recognised that some time will benecessary to develop and establish a system and associated procedures to implementthis new requirement. Therefore, companies performing their first Product QualityReview in 2006 should cover a period of at least 6 months. Subsequent reports shouldcover a full 12 months' period.Chapter 6 on Quality Control includes new provisions for an On-going StabilityProgramme and an update for reference samples and is also published in aconsolidated version. The revised Chapter will come into operation on 01 June 2006.

10/10/2005

Restructuring of GMP guide - Revised basic requirements for active substances usedas starting materials now public as GMP Part II The Commission has published the basic requirements for the manufacture of activesubstances used as starting materials as GMP Part II (154 KB) replacing theformer GMP Annex 18. Compared to Annex 18, the modifications refer to theintroduction, indicating that the guide is applicable both for active substances used inthe manufacture of human and veterinary medicinal products. The technicalrequirements remain unchanged compared to the former Annex 18.A legal provision for the application and publication of GMP Part II is laid down in Article47 and Article 51 of Directive 2001/83/EC and 2001/82/EC, respectively. Member Statesshall bring the requirements into force by 30 October 2005 at the latest.With the implementation of GMP provisions for active substances the GMP Guide wasre-structured. The existing basic requirements have now become Part I, the existingannexes remain, except for Annex 18, which has now been withdrawn. For additionalinformation see revisedintroduction to the GMP guide .

10/10/2005

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Compilation of Community Procedures on Inspections and Exchange of Informationupdated to include new EU formats and procedures The updated Compilation includes a revised EU format for the manufacturingauthorisation. In addition, the EU inspection report format was updated and theguideline on the preparation of reports under the centralised system revised. A newformat for GMP certificates was elaborated. A new procedure on inspection triggers forthe conduct of inspections at the premises of manufacturers of active substances usedas starting materials was developed jointly with the Member States' authorities. Thenew September 2004 version of the Compilation was published by the EMEA on behalfof the Commission after the Veterinary Pharmaceutical Committee and thePharmaceutical Committee had been consulted.There was a need to update the currently existing manufacturing authorisation andinspection report formats based on practical experiences and the new provisions ofDirective 2001/83/EC and of Directive 2001/82/EC, as amended by Directives2004/28/EC and 2004/27/EC respectively. In addition, the Commission was entitled topublish guidance on the form and content of the GMP Certificate (Articles 47 and 51respectively).The new "Guidance on occasions when it is appropriate for competent authorities toconduct inspections at the premises of manufacturers of active substances used asstarting materials" was developed in the light of the new obligations of manufactures toensure the application of GMP for active substances and corresponding inspectionprovisions for Member States.The Compilation of Community Procedures is under ongoing development by theEMEA, using Member States' expertise through the Ad Hoc Working Group of GMPinspectors.

17/06/2005

International Conference on Harmonization : ICH Q9 on Risk Management has reachedstep 2 After having reached step 2 the document ICH Q9 Quality Risk Management is nowavailable as "Note for Guidance on Quality Risk Management"

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(EMEA/INS/GMP/157614/2005-ICH - transmission to Interested parties May 2005)for public consultation on the Website of the EMEA.The document is meant to complement GMP guidelines and to support existing andfuture guidelines published by CHMP and CVMP concerning the quality of medicinalproducts.

Although developed within ICH the processes, tools and examples are expected to beequally useful in the context of medicinal products for veterinary use. Public commentson this point would be particularly welcome.

Comments should be sent to Sabine.Atzor@ec.europa.eu and in parallel toDavid.Cockburn@emea.eu.int by 31 August 2005.

- EMEA's inspection website "Compilation of Community Procedures" -EudraLexVolume 4 - Medicinal products for human and veterinary use : Good manufacturingpractices

08/03/2005

Concept Papers available for revision of GMP Guide, Sub-Chapter 3.6 on dedicatedfacilities and Annex 14, defining requirements for medicinal products derived fromhuman blood or plasma.For further information see the EMEA website on this subject.Deadline for comments is 30.05.2005 to david.cockburn@emea.eu.int andsabine.atzor@ec.europa.eu.

08/03/2005

Inspections at Manufacturers of Active Substances - Guidance on Grounds (Triggers)for Inspection - for public consultationThe Commission services present a draft of the new Guidance on the occasions whenit is appropriate for Competent Authorities to conduct inspections at the premises ofmanufacturers of active substances used as starting materials (34 KB) . Article 111of Directive 2001/83/EC, as amended by Directive 2004/27/EC, and Article 80 of

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Directive 2001//82/EC, as amended by Directive 2004/28/EC, include new provisions forinspections in this field. The Ad Hoc Working Group of GMP Inspection Services at theEMEA has developed this guidance as a harmonised approach for inspections underthe amended EC legislation.

Please send your comments by 4 April 2005 to sabine.atzor@ec.europa.eu andgmp@emea.eu.int.After finalisation the document will be published under the Compilation of CommunityProcedures.

08/03/2005

Detailed GMP guidelines for active substances used as starting materials - publicconsultationThe Commission presents a draft of the detailed guidelines on the principles of goodmanufacturing practice for active substances used as starting materials.

The draft revision only affects the introductory text (section1) of the GMP Annex 18, which has been published on the Commission´s website since 2001

implementing the Q7A guideline developed between the ICH partners EC, USA andJapan. No changes to the remaining sections 2-20 of the Annex are currentlyenvisaged.

The Commission would like to emphasise that the document will be equally applicableto the veterinary sector. To take the account of the needs of the veterinary sector,ectoparacitides are excluded from the scope. Specific modifications, where identifiedfor active substances to be used in veterinary medicinal products, can be developed inthe GMP annexes 4 and 5 as appropriate.

Changes refer to

The structural implementation in the GMP guide as Part II of the "Basic Requirements"instead of Annex 18. The current "Basic Requirements" of the GMP guide will becomePart I in the future. The remaining annexes will supplement both Part I and Part II as

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appropriate and a programme to review the guidance already given on activesubstances in annexes 2-7 is being undertaken. EMEA will publish a Concept paper onthis shortly.

Section I "Introduction" to the existing Annex 18 (the future Part II of the basicrequirements).

Specific exclusion of veterinary ectoparaciticides

Please send your comments by 4 April 2005 to sabine.atzor@ec.europa.eu andgmp@emea.eu.int.

The Commission intends to publish the final version before 30 October 2005. Legalprovisions for this guideline are vested in Article 47 of Directive 2001/83/EC, asamended by Directive 2004/27/EC, for human medicinal products and Article 51 ofDirective 2001/82/EC, as amended by Directive 2004/28/EC, for veterinary medicinalproducts.

08/03/2005

Authorisations for manufacturing and import & GMP certificates - form and content forpublic consultationThe Commission publishes a draft format for the authorisations for manufacturing andimport (32 KB) for public consultation. The Ad Hoc Working Group of GMPInspection Services at the EMEA has developed the draft based on a format developedand published previously within the Compilation of Community Procedures

The second draft document for public consultation refers to the GMP certificate (28KB) for manufacturers. Within 90 days of an inspection, the competent authorities shallissue such a certificate, if compliance with GMP requirements can be confirmed.Member States will have to implement these provisions by 30 October 2005. The formatis based on that used in connection with the Mutual Recognition Agreements and hasbeen adapted for application in all circumstances in which a GMP certificate is issued.

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Please send your comments by 4 April 2005 to sabine.atzor@ec.europa.eu andgmp@emea.eu.int.

The Commission intends to publish the final version before 30 October 2005. Legalprovisions for the form and content of the authorisation and the certificate of GMP arevested in Article 47 of Directive 2001/83/EC, as amended by Directive 2004/27/EC, forhuman medicinal products and Article 51 of Directive 2001/82/EC, as amended byDirective 2004/28/EC, for veterinary medicinal products.

15/07/2004

Consultation on a proposal for a new Annex 19 (Reference Samples and RetentionSamples) to the EU GMP Guide (Volume 4) The new annex to the EU GMP Guide provides guidance on the taking and holding ofreference samples of starting materials, packaging materials and finished products aswell as for retention samples of finished products. The annex provides definitions of theterms "reference sample" and "retention sample", which are often incorrectlyconsidered as synonyms. The guidance is wide ranging in scope and includes thecase of multiple manufacturing sites, the position with respect to importers and whatshould happen when a manufacturing site ceases to operate. Updated guidance isalso given on the size of reference samples and a consequential amendment willtherefore be necessary to Chapter 6 section 14 of the GMP Guide to maintainconsistency. The Pharmaceutical Committee has endorsed the proposal by writtenprocedure. The document is released for a consultation period until 15 January 2005.Comments should be sent to GMP@emea.eu.int and Karin.Krauss@ec.europa.eu.

22/01/2004

GMP - Compilation of Community Procedures on Inspections and Exchange ofInformationOn behalf of the European Commission the EMEA is now responsible for maintainingand publishing the Compilation of Community Procedures. The Compilation is a

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collection of GMP inspection-related procedures and forms agreed by the GMPinspectorates of all Member States and designed to facilitate administrativecollaboration, harmonisation of inspections and exchange of inspection-relatedinformation. EMEA is going to reformat, review and update the procedures andincorporate new additions as soon as possible after they have been agreed.EMEA's inspection website "Compilation of Community Procedures" 19/12/03 Note tothe Members of the GMP Inspectors group - Interpretation of Articles 51(1)b of Directive2001/83/EC and 55(1)b of Directive 2001/82/EC. (18 KB) The document outlines the principles of import of medicinal/veterinary medicinalproducts from 3rd countries and the obligation of retesting of batches.

15/12/2003

"On going Stability - Addition to Chapter 6 to the EU Guide to Good ManufacturingPractice" (80 KB) The additional text "On going Stability" for Chapter 6 to the EU GMP Guide has beenadopted by the Ad hoc GMP inspectors Working Group at their meeting in October 2003.The proposed text provides guidance on ongoing stability monitoring thereby clarifyingthat ongoing stability monitoring is a Community GMP expectation in line with the GMPrequirements of our MRA partners. The Pharmaceutical Committee has endorsed theproposal through written procedure. The document is released for a consultationperiod until 15 June 2004. Comments should be sent to GMP@emea.eu.int and inparallel to Karin.Krauss@ec.europa.eu.

15/12/2003

"Product Quality Review - Addition to Chapter 1 to the EU Guide to Good ManufacturingPractice" (100 KB) The additional text "Product Quality Review" for Chapter 1 to the EU GMP Guide hasbeen adopted by the Ad hoc GMP inspectors Working Group at their meeting in July2003. The proposal arises from the experience of Member States' inspectorates wherequality problems with products on the market leading to recall could have beenanticipated if the manufacturer/marketing authorisation holder had operated a system

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for formally reviewing process consistency and trends. The Pharmaceutical Committeehas endorsed the proposal through written procedure. The document is released for aconsultation period until 15 June 2004. Comments should be sent toGMP@emea.eu.int and in parallel to Karin.Krauss@ec.europa.eu.

27/10/2003

Commission Directive 2003/94/EC , of 8 October 2003, laying down the principlesand guidelines of good manufacturing practice in respect of medicinal products forhuman use and investigational medicinal products for human useReplacement of Commission Directive 91/356/EC of 13 June 1991 to cover goodmanufacturing practice of investigational medicinal products.

03/06/2003

Revision of Annex 1 (Manufacture of sterile medicinal products) to the EU GMP Guide(Volume 4) The revision of Annex 1 to the EU GMP Guide has been adopted by the Ad hoc GMPinspectors Working Group at their meeting on 28-29 April 2003. The amendments onlyconcern section 3 harmonising where appropriate the environmental standards forclean rooms laid down in the GMP Guide with those laid down in internationalstandards (e.g. EN/ISO 14644-1) together with a minor change to section 20. Theremainder of the annex is unchanged. The Pharmaceutical Committee has adopted therevised version at its meeting on 15 May 2003 fixing 1 September 2003 as date forcoming into operation.

10/03/2003

"Qualifizierung und Validierung" The document is the German version of the Annex 15 to the EU GMP Guide with title"Qualification and Validation". The updated version has been provided by Germany(ZLG) and has been agreed by the German "Länder", the German Health Ministry, theGerman Working Group "Medicinal Gases" and also the Austrian Authorities. Germany

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has asked us to add this updated version and to remove the old DE version from ourwebsite.EudraLexVolume 4 - Medicinal products for human and veterinary use : Goodmanufacturing practices

10/03/2003

"Zertifizierung durch eine sachkundige Person und Chargenfreigabe" The document is the German version of the Annex 16 to the EU GMP Guide with title"Certification by a Qualified person and Batch Release". The version has been providedby Germany (ZLG) and has been agreed by the German "Länder", the German HealthMinistry, the German Working Group on "Inspections" and also the Austrian Authorities.Germany has asked us to add this version to the versions (EN, EL, ES, FR, IT, NL)already published on our website.EudraLexVolume 4 - Medicinal products for human and veterinary use : Goodmanufacturing practices

10/03/2003

"Parametrische Freigabe" The document is the German version of the Annex 17 to the EU GMP Guide with title"Parametric Release". The version has been provided by Germany (ZLG) and has beenagreed by the German "Länder", the German Health Ministry, the German WorkingGroup on "Inspections" and also the Austrian Authorities. Germany has asked us toadd this version to the versions (EN, ES, FR, IT, NL) already published on our website.EudraLexVolume 4 - Medicinal products for human and veterinary use : Goodmanufacturing practices

20/11/2002

Consultation on a new proposal for a revision of Annex 1 (Manufacture of sterilemedicinal products) to the EU GMP Guide (Volume 4) (122 KB) The new proposal for a revision of Annex 1 to the EU GMP Guide has been adopted by

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GMP inspectors at their meeting on 23 October 2002. The amendments have primarilybeen introduced to harmonise the environmental standards for clean rooms laid downin the GMP Guide with those laid down in international standards (e.g. EN/ISO 14644-1). The Pharmaceutical Committee has endorsed the proposal at its meeting on 13November 2002. The document is released for a consultation period until 10 January2003.Comments should be sent in parallel to GMP@emea.eu.int and toKarin.Krauss@ec.europa.eu

02/05/2002

Modifications to Commission Directive 91/356 of 13 June 1991 laying down theprinciples and guidelines of good manufacturing practice for medicinal products forhuman use, as required by Directive 2001/20/EC (105 KB) Following discussion within the working parties on medicinal products and inspections(Good manufacturing practices and Good clinical practices sectors) modifications toCommission Directive 91/356 are proposed to incorporate the principles andguidelines of good manufacturing practice for investigational medicinal productsreferred to in Article 13.3 and in the requirements for a manufacturing authorisationreferred to in Article 13.1 of the Directive on Good Clinical Practice.The draft proposal is released for a 3 months consultation period. (105 KB) Two column informal working document (138 KB)

21/04/2002

EudraLex Volume 4 : Medicinal products for human and veterinary use : Goodmanufacturing practicesDE, ES, FR, IT, NL versions of annexes 6, 15, 16, 17 are available

12/04/2002

Publication of Guidance Document on the Implications of the Operational phase of theGMP annexes to the Protocol to the European agreement on Conformity assessment

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and Acceptance of industrial products (PECA) with European Union associatedcountries (213 KB) Following the entry into force of the GMP and Batch certification annex of the PECAagreements with Hungary on 1st December 2001 and Czech Republic on 1st January2002, the Commission has prepared a document which aims to describe and provideguidance on the key activities which should be undertaken by industry and regulators inthe EUand in an associated country with which a PECA concerning Good ManufacturingPractice (GMP) has entered into force. The content of the manufacturer's certificate ofcompliance and the batch certificate which must be prepared by the company aredescribed.

22/11/2001

Revision of Good Manufacturing Practices annex 13 to implement directive on ClinicalTrials on medicinal products for human use. Following discussion within the working parties on medicinal products and inspections(Good manufacturing practices and Good clinical practices sectors) the Annex 13"Manufacture of investigational medicinal products" of the Guide provided by theCommission Directive 91/356/EEC laying down the principles and guidelines of goodmanufacturing practices (GMP) for medicinal products for human use (Volume 4 -Pharmaceutical legislation - Good manufacturing practices) has been revised in orderto implement the "Detailed Guidelines" for the manufacture and the labelling ofinvestigational medicinal products as provided for in Directive 2001/20/EC relating tothe implementation of good clinical practice in the conduct of clinical trails on medicinalproducts for human use.The draft 1 is released for a 6 months consultation period.COMMENTS ARE EXPECTED BEFORE 1 MAY 2002 and should be sent toarielle.north@ec.europa.eu

15/10/2001

New version of compilation of Community procedures on inspections and exchange of

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information (465 KB) An updated compilation of administrative procedures for GMP inspections has beenprepared.This compilation updates and replaces document III/5698/94 which had been preparedwithin the ad hoc group of inspectors and published by the Commission. It includesguidance for inspectors on rapid alerts, exchange of information betweeninspectorates, batch certificates and a format for a community inspection report.

19/07/2001

ICH guideline published as annex to the EU Guide to Good Manufacturing Practice,Eudralex Volume 4On 18th July 2001, the Commission adopted a new legislative proposal whichintroduces a requirement for pharmaceutical manufacturers to use only activesubstances which have been manufactured according to GMP in the manufacture ofmedicinal products. Until this comes into force requirements for GMP for activesubstances and hence the applicability of this guideline will not be mandatory in theEU. However when there are causes for concern, or when required by certain MemberStates, GMP inspections of active ingredient manufacturers may be carried out by thecompetent authorities of Member States. In these cases, and in particular when theseare performed in the context of an application for a centralised authorisation, it hasbeen agreed that the inspectors of the competent authorities in the EU will inspectagainst the requirements in this guideline, now published as Annex 18 to the EU guideto Good Manufacturing Practice.Annex 18 EudraLex Volume 4

12/07/2001

New annexes to the EU Guide to Good Manufacturing Practice, Eudralex Volume 4Following discussion within the Working party on medicines and inspections, 4 newannexes to Eudralex Volume 4 of the Rules governing medicinal products in theCommunity have been finalised. Annex 6 is a revision to the current annex on

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Manufacture of Medicinal gases and should replace current requirements fromSeptember 2001. Annex 15 on Qualification and Validation is also due to come intooperation In September 2001. Annex 16 concerns the arrangements for Certification bya Qualified Person and Batch Release in the Community and is due to come intooperation from January 2002. Annex 17 addresses Parametric Release and is alsodue to come into operation in January 2002. These annexes will also be translated intothe current language versions of Eudralex Volume 4.Annex 6 (139 KB) Annex 15 (136 KB) Annex 16 Annex 17 (124 KB) EudraLex Volume 4

07/06/2001

Revision of Annex 1 to Volume 4 of The Rules Governing Medicinal Products in theEuropean UnionFollowing discussion in the EU inspectors' group, Paragraph 42 of Annex 1 to Volume 4

of The Rules Governing Medicinal Products in the European Union has beenrevised to take account of current practices. These changes have necessitated threeadditional entries in the glossary (27 KB). The changes have been introduced inEnglish into the relevant part of the documents on this web-site. Translations of thechanges will be available in the near future and the corresponding edits will be made.The changes are indicated here for your information(EudraLex Vol 4)View modifications (59 KB)

06/02/2001

Draft revised version of Annex15 of the GMP: Validation master plan : Designqualification, installation and operational qualification, non-sterile process validation,cleaning validation for information. (131 KB) 26/01/01 Revised Draft of Annex to theGuide to Good Manufacturing Practice for Medicinal Products: Certification by a

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Qualified Person and Batch Release (178 KB) (available for comments until 15March 2001) 25/10/00

Revised Version of Annex 14 - Manufacture of medicinal products derived from humanblood or plasma to the EU Guide to Good Manufacturing Practice

27/07/2000

ICH Step 2 Document on GMP for active pharmaceutical ingredients released forconsultation

Following discussions within ICH, agreement on a draft ICH Good ManufacturingPractice Guide for Active Pharmaceutical Ingredients (128 KB) has been reached at"Step 2" of the ICH process. The document is now released for public consultation. Inorder to facilitate the submission and review of comments on this draft guide, twomethods for submitting comments have been developed. Interested parties maysubmit comments to the European Commission either in writing in the normal manneror by downloading a comments template . Electronic submission of comments isencouraged, since it is anticipated that widespread use of this method will increase theeffectiveness of the guidance development process. This document will become anannex to Volume 4 of the Rules Governing Medicinal Products in the European Union.

Please submit comments using the form provided to Gordon.Munro@mca.gov.uk andEmer.Cooke@ec.europa.eu by 30th September 2000.

27/04/2000

Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects has beenagreed by the inspectors group for use within the Community from 1st April 2000.English Version (123 KB) Version Française (123 KB)

10/04/2000

A draft text of Annex 17 Parametric Release to the EU Guide to Good Manufacturing

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Practice was released for consultation on the 7 April 2000. The proposed deadline forcomments is September 2000. 31/03/00 Annex 14 Manufacture of medicinal productsderived from human blood or plasma to the EU Guide to Good Manufacturing Practicewas adopted at the Ad-hoc meeting of the GMP Inspection services on the 11 February2000. It is expected to come into operation on the 1 September 2000 31/03/00 A drafttext of Annex 6 Manufacture of medicinal gases to the EU Guide to Good ManufacturingPractice was released for industry consultation on the 23 March 2000. The Proposeddeadline for comments is the 31 August 2000.

17/12/1999

GMP Inspection report - Community format DocumentA basic format for the presentation of Good Manufacturing Practice Inspection report inthe community has been adopted for use for a trial period of one year. This format isnow available in all Community languages.PDF format (84 KB)

Word format

9/12/1999

Good Manufacturing Practice for medicinal products - Certification by a qualified personand batch releaseA draft annex to the 1997 EU Guide to Good Manufacturing Practice - Eudralex Volume 4is released for consultation (121 KB) . Comments are expected before May 2000.

30/10/1999

Good Manufacturing Practice - Validation master plan : Design qualification, installationand operational qualification, non-sterile process validation, cleaning validation.A draft annex to the 1997 EU Guide to Good Manufacturing Practice - Eudralex Volume 4is released for consultation (273 KB) .

21/10/1999

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GMP Inspection report (124 KB) - Community formatA basic format for the presentation of Good Manufacturing Practice Inspection report inthe community has been adopted for use for a trial period of one year. This format isonly available in English version (85 KB), the other language versions will beavailable soon. 23/09/99 Community Basic Format for Manufacturing Authorisation. Abasic format and content (124 KB) for manufacturing authorisations granted bycompetent authorities in accordance with Article 16 of Council Directive 75/319/EC andArticle 24 of Council Directive 81/851/EC has been agreed. This format is now availablein all Community languages.

04/02/1999

Inspection and Control of medicinal products - information on the outcome of the expertgroup meeting on 17 and 18 December 1998. (58 KB) 24/09/98 A revised guidelineon Control Authority Batch Release of Vaccines and Blood Products. (75 KB) In September 1998 the Pharmaceutical Committee approved a revised guideline onControl Authority Batch Release of Vaccines and Blood Products which will replace two1994 guidelines, one for vaccines and the other for blood products (III/3859/92). It hasbeen drafted by the Network of EU OMCLs responsible for official batch release ofvaccines and blood products in consultation with the industry. It will facilitate andimprove the transparency of the mutual recognition of official batch release. Annex IId:the Control authority batch release certificate of approval for plasma pools, will beinclude once it has been finalised (later this year).

03/06/1998

Inspection and GMP (31 KB) . Information on the outcome of the Expert Group onInspection and Control of medicinal products Meeting 20 March 1998

29/05/1998

GMP for medicinal products derived from human blood or plasma (40 KB) . DG IIIreleases a draft revision of Annex 14 to the EU Guide to Good Manufacturing Practice,

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comments are requested before 31 August 1998

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