Guide to GMP for Medicinal Products(PIC/S)
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Guide to GMP for Medicinal Products(PIC/S) โดย เภสัชกรสมบัติ หิรัญศุภโชติ สํานักงานคณะกรรมการอาหารและยา
Transcript of Guide to GMP for Medicinal Products(PIC/S)
Guide to GMP for Medicinal Products(PIC/S)
โดยเภสัชกรสมบัติ หิรัญศุภโชติ
สํานักงานคณะกรรมการอาหารและยา
Guide to GMP for Medicinal Products(PIC/S)• Download ขอมูล Guideline PIC/S GMP ไดจากเว็บไซด• www.picscheme.org
– PUBLICATIONS• PIC/S GUIDE
– PE009-2» GUIDE TO GOOD MANUFACTURING
PRACTICE» FOR MEDICINAL PRODUCTS
Guide to GMP for Medicinal Products(PIC/S)
1. เนื้อหามีทั้งหมด 143 หนากระดาษ A42. แบงเนื้อหาออกเปน
– 1 บทนํา ( INTRODUCTION )– 9 บทหลัก (CHAPTER)– 18 ภาคผนวก(Annex)
PIC/S AND EU GMP
CHATER 1 QUALITY MANAGEMENTCHATER 2 PERSONNELCHATER 3 PREMISES AND EQUIPMENTCHATER 4 DOCUMENTATIONCHATER 5 PRODUCTIONCHATER 6 QUALITY CONTROLCHATER 7 CONTRACT MANUFACTURE AND
ANALYSISCHATER 8 COMPLAINTS AND PRODUCT
RECALLCHATER 9 SELF INSPECTION
AnnexesAnnex 1 Manufacture of sterile medicinal productsAnnex 2 Manufacture of biological medicinal products for
human useAnnex 3 Manufacture of radiopharmaceuticalsAnnex 4 Manufacture of veterinary medicinal products other
than immunologicalsAnnex 5 Manufacture of immunological veterinary medical
productsAnnex 6 Manufacture of medicinal gasesAnnex 7 Manufacture of herbal medicinal productsAnnex 8 Sampling of staring and packaging materialsAnnex 9 Manufacture of liquids, creams and ointments
AnnexesAnnex 10 Manufacture of pressurised metered dose
aerosol preparations for inhalationAnnex 11 Computerised systemsAnnex 12 Use of ionising radiation in the manufacture
of medicinal productsAnnex 13 Manufacture of investigational medicinal
productsAnnex 14 Manufacture of products derived from human
blood or human plasmaAnnex 15 Oualification and validaitonAnnex 16 (Quaified person and batch release)Annex 17 Parametric releaseAnnex 18 GMP Guide for active pharmaceutical
ingredients
PIC/S : PE 009-2, 1 July 2004
INTRODUCTIONIn order to further facilitate the removal of
barriers to trade in medicinal products, to promote uniformity in licensing decisions and to ensure themaintaining of hight standards of quality assurance inthe development, manufacture and control of medicinalproducts throughout Europe, it was agreed to harmonize the rules of GMP applied underPharmaceutical Inspection Convention(PIC) and the Pharmaceutical Inspection Co-operation Sheme(PIC/S)to those of the EU Guide to Good Manufacturing Practice for Medicinal Products and its Annexes.
PIC/S : PE 009-2, 1 July 2004
INTRODUCTIONCHAPTER 1 - QUALITY MANAGEMENT
PrincipleQuality AssuranceGood Manufacturing Practice for Medicinal products (GMP)Quality Control
CHAPTER 2 - PERSONNELPrincipleGeneralKey PersonnelTrainingPersonal Hygiene
PIC/S : PE 009-2, 1 July 2004
CHAPTER 3 - PREMISES AND EQUIPMENTPrinciplePremisesGeneralProduction AreaStorage AreasQuality Control AreasAncillary AreasEquipment
PIC/S : PE 009-2, 1 July 2004
CHAPTER 4 - DOCUMENTATIONPrincipleGeneralDocuments requiredSpecificationsSpecifications for starting and packaging materialsSpecifications for intermediate and bulk productsSpecifications for finished products
PIC/S : PE 009-2, 1 July 2004
Manufacturing Formula and Processing InstructionsPackaging InstructionsBatch Processing RecordsBatch Packaging RecordsProcedures and recordsReceiptSamplingTestingOther
PIC/S : PE 009-2, 1 July 2004
CHAPTER 5 - PRODUCTIONPrincipleGeneralPrevention of cross-contamination in productionValidationStarting materialsProcessing operations - Intermediate and bulk productsPackaging materialsPackaging operationsFinished productsRejected, recovered and returned materials
PIC/S : PE 009-2, 1 July 2004
CHAPTER 6 - QUALITY CONTROLPrincipleGeneralGood Quality Control Laboratory PracticeDocumentationSamplingTestingCHAPTER 7 - CONTRACT MANUFACTURE AND ANALYSISPrincipleGeneralThe Contract GiverThe Contract AcceptorThe Contract
PIC/S : PE 009-2, 1 July 2004
CHAPTER 8 - COMPLAINTS AND PRODUCT RECALLPrincipleComplaintsRecalls
CHAPTER 9 - SELF INSPECTIONPrinciple
CHAPTER 1QUALITY MANAGEMENT
The holder of a manufacturing authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with therequirements of the marketing authorisation and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers and by the distributors.
To achieve the quality objective reliably there must
be a comprehensively designed and correctly
implemented system of Quality Assurance
Incorporating Good Manufacturing Practice and thus
Quality Control. It should be fully documented and
its effectiveness monitored. All parts of the Quality
Assurance systems should be adequately resourced
with competent personnel, and suitable and
sufficient premises, equipment and facilities.
CHAPTER 1QUALITY MANAGEMENT
CHAPTER 2PERSONNEL
The establishment and maintenance of a satisfactory
system of quality assurance and the correct
manufacture of medicinal products relies upon
people. For this reason there must be sufficient
qualified personnel to carry out all the tasks which
are the responsibility of the manufacturer. Individual
responsibilities should be clearly understood by the
individuals and recorded.
All personnel should be aware of the principles of
Good Manufacturing Practice that affect them and
receive initial and continuing training, including
hygiene instructions, relevant to their needs
CHAPTER 2PERSONNEL
CHAPTER 3PREMISES AND EQUIPMENT
Premises and equipment must be located, designed,
constructed, adapted and maintained to suit the
operations to be carried out. Their layout and design
must aim to minimize the risk of errors and permit
effective cleaning and maintenance in order to avoid
cross-contamination, build up of dust or dirt and, in
general, any adverse effect on the quality of products.
CHAPTER 4DOCUMENTATION
Good documentation constitutes an essential part of
the quality assurance system. Clearly written
documentation prevents errors from spoken
communication and permits tracing of batch history.
Specifications, Manufacturing Formulae and instruction,
procedures, and records must be free from errors and
available in writing. The legibility of documents is of
paramount importance.
CHAPTER 5PRODUCTION
Production operations must follow clearly defined
procedures; they must comply with the principles of
Good Manufacturing Practice in order to obtain
products of the requisite quality and be in accordance
with the relevant manufacturing and marketing
authorizations.
CHAPTER 6QUALITY CONTROL
Quality Control is concerned with sampling, specifications and testing as well as the organisation, documentation and relevant tests are carried out, and that materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory. Quality Control is not confined to laboratory operations, but must be involved in all decisions which may concern the quality of the product. The independence of Quality Control from production is considered fundamental to the satisfactory operation of Quality Control.
CHAPTER 7CONTRACT MANUFACTURE AND ANALYSIS
Contract manufacture and analysis must be correctly
defined, agreed and controlled in order to avoid
misunderstandings which could result in a product or
work of unsatisfactory quality. There must be a written
contract between the Contract Giver and the Contract
Acceptor which clearly establishes the duties of each
party. The contract must clearly state the way in which
the authorised person releacing each batch of product
for sale exercises his full responsibility.
CHAPTER 8COMPLAITNS AND PRODUCT RECALL
All complaints and other information concerning
potentially defective products must be carefully
reviewed according to written procedures. In order to
provide for all contingencies, a system should be
designed to recall, if necessary, promptly and
effectively products known or suspected to be defective
from the market..
CHAPTER 9SELF INSPECTION
Self inspections should be conducted in order to
monitor the implementation and compliance with
Good Manufacturing Practice Principles and to
propose necessary corrective measures.
WHO Technical Report Series, No. 908, 2003
Annex 4 : Good Manufacturing Practices for pharmaceutical products: main principles
Introduction
General considerations
Glossary
Quality management in the drug industry: philosophy and essential elements
1. Quality assurance
2. Good manufacturing practices for pharmaceutical products (GMP)
3. Sanitation and hygiene
WHO Technical Report Series, No. 908, 2003
4. Qualification and validation
5. Complaints
6. Product recalls
7. Contract production and analysis
General
The contract giver
The contract accepter
The contract
WHO Technical Report Series, No. 908, 2003
8. Self-inspection and quality auditsItems for self-inspectionSelf-inspection teamFrequency of self-inspectionSelf-inspection reportFollow-up actionQuality auditSuppliers’ audits and approval
9. PersonnelGeneralKey personnel
WHO Technical Report Series, No. 908, 2003
10. Training11. Personal hygiene12. Premises
GeneralAncillary areasStorage areasWeighing areasProduction areasQuality control areas
13. Equipment
WHO Technical Report Series, No. 908, 2003
14. MaterialsGeneralStarting materialsPackaging materialsIntermediate and bulk productsFinished productsRejected, recovered, reprocessed and reworked materialsRecalled productsReturned goodsReagents and culture mediaReference standardsWaste materialsMiscellaneous
WHO Technical Report Series, No. 908, 2003
15. DocumentationGeneralDocuments required
16. Good practices in productionGeneralPrevention of cross-contamination and bacterial contamination during productionProcessing operationsPackaging operations
17. Good practices in quality controlControl of starting materials and intermediate, bulk and finished productsTest requirementsBatch record reviewStability studies
References
