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8/8/2019 cGMP and it’s Importance in Herbal Preparations 2010.
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cGMP AND IT·S IMPORTANCE INcGMP AND IT·S IMPORTANCE IN
HERBAL PREPARATIONS.HERBAL PREPARATIONS.
Dr.Ajmal Nasir
Executive Director Technical Executive Director Technical
Highnoon Laboratories Pakistan (Pvt.) ltd Highnoon Laboratories Pakistan (Pvt.) ltd
8/8/2019 cGMP and it’s Importance in Herbal Preparations 2010.
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J an 2010 Dr Ajmal Nasir
ajmalnasir@hotmail.com.
WHAT ARE
GMPs?
Regulations describing the methods,equipment,
Facilities,and controls to produce,
Human &veterinary products(21CFR 210-211)
Medical devices (21CFR 820)
Processed foods (21CFR 100)
In U.S called cGMP to addDynamism in expectations.
8/8/2019 cGMP and it’s Importance in Herbal Preparations 2010.
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J an 2010 Dr Ajmal Nasir
ajmalnasir@hotmail.com.
HI I
K U
First official document in anada in 1957
current MP in 1980·s
STATUS I PAKISTAN.
riginally based upon best industry practices.
Evolved with improvement of technology
and practices.
First MP regulation in 1963.
Mandatory for Medicine & evices.
Not mandatory for Herbal Preparations.
8/8/2019 cGMP and it’s Importance in Herbal Preparations 2010.
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J an 2010 Dr Ajmal Nasir
ajmalnasir@hotmail.com.
WHY cGMP? Q ALITY
SAFETY
EFFICACY
P RITY
CONSISTENCY
STABILITY
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J an 2010 Dr Ajmal Nasir
ajmalnasir@hotmail.com.
BASIC ELEMENTS OF
cGMP. DEFINED Q ALITY POLICY.
Q ALITY ASS RANCE SYSTEM.
DEFINED MAN FACT RING PROCESS.
VALIDATED PROCED RES.
TRAINED Q ALIFIED STAFF. ADEQ ATE SPACE& PREMISES.
S ITABLE EQ IPMENT &SERVICES.
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J an 2010 Dr Ajmal Nasir
ajmalnasir@hotmail.com.
CORRECT MATERIALS & PAC AGING.
S ITABLE STORAGE & TRANSPORTATION.
PROPER SANITATION & EQ IPMENT
MAINTENANCE.
PROPER MAN FACT RING RECORD.
RE CALL PROCED RE.
COMPLAINT HANDLING.
BASIC ELEMENTS OF
cGMP.
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J an 2010 Dr Ajmal Nasir
ajmalnasir@hotmail.com.
COMMON REQ IREMENTS
OF
VARIO S cGMPS.
Proper design,maintenance and cleaning of equipment.
Written and approved operating procedures.
Independent Quality nit (Q.A / Q.C)
Committed and well trained personnel and Management.
There are differences depending on regulatory bodiesThere are differences depending on regulatory bodies
e.g Training is required by Canada, .S.and E.C GMPs.e.g Training is required by Canada, .S.and E.C GMPs.
FDA requires Annual product review . Not required byFDA requires Annual product review . Not required by
Canada.Canada.
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J an 2010 Dr Ajmal Nasir
ajmalnasir@hotmail.com.
What are
HERBAL PREPARATIONS
(Traditional Herbal Medicines). THM
are finished drugs used for self
medication.
Documented in folkloric literature.
May contain Herbal based or
Chemically defined excepients in
addition to active substance.
8/8/2019 cGMP and it’s Importance in Herbal Preparations 2010.
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J an 2010 Dr Ajmal Nasir
ajmalnasir@hotmail.com.
Herbal ingredients include aerial or
underground parts of plants, or other plant
material, or combination thereof, whether in crude state or as plant preparations.
Plant material may include juices, gums,fatty oils, essential oils and any other
substances of this nature.
What are
HERBAL PREPARATIONS
Contd.
8/8/2019 cGMP and it’s Importance in Herbal Preparations 2010.
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J an 2010 Dr Ajmal Nasir
ajmalnasir@hotmail.com.
DO WE NEED TO IMPLEMENTDO WE NEED TO IMPLEMENT
SAME STANDARDSSAME STANDARDS
FORFOR
HERBAL PREPARATIONS ?HERBAL PREPARATIONS ?
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J an 2010 Dr Ajmal Nasir
ajmalnasir@hotmail.com.
YES YES , IT IS ESSE NTIAL.
Herbals are used by same end user.
Has to be safe pure and efficacious.
As old as 5000 years back in History.
80 % of world population uses THM
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J an 2010 Dr Ajmal Nasir
ajmalnasir@hotmail.com.
ADVANTAGES WITH cGMP
CONSISTENT QUALITY.CONSISTENT QUALITY.
BETTER CONTROL.BETTER CONTROL.
MINIMUM OF LOSSES.MINIMUM OF LOSSES.
NO REGULATORY /QUALITY ISSUES.NO REGULATORY /QUALITY ISSUES.
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J an 2010 Dr Ajmal Nasir
ajmalnasir@hotmail.com.
G IDELINES AND STANDARDS
WHO General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine , WHO/EDM/TRM/2000.1,
WHO Geneva, 2000 (19 Swiss Francs)
Guidelines for the Appropriate use of Herbal Medicines (ISBN 92 9061 124 3), WHO Regional Publications, Western
Pacific Series No. 23, WHO Regional Office for the Western Pacific, Manila, 1998 (7.50 Swiss Francs)
Guidelines for the assessment of herbal medicines *, **, (ISBN 92 4 120863 5), WHO Technical Report Series, No.863, WHO Geneva, 1996 (35 Swiss Francs) ± these guidelines are also included in Quality Assurance of Pharmaceuticals: A compendium of guidelines and related materials, Volume 1.
Good manufacturing practices: supplementary guidelines for the manufacture of herbal medicinal products *, **,Annex 8 of (ISBN 92 4 120863 5), WHO Technical Report Series, No. 863, WHO Geneva, 1996 (35 Swiss Francs) ±these guidelines are also included in Quality Assurance of Pharmaceuticals: A compendium of guidelines and related
materials, Volume 2, Good manufacturing practices and inspection.
Guidelines for Training Traditional Health Practitioners in Primary Health Care, WHO/SHS/DHS/TRM/95.5, WHOGeneva, 1995
Research guidelines for evaluating the safety and efficacy of herbal medicines (ISBN 92 9061 110 3), WHO RegionalOffice for the Western Pacific, Manila, 1993 (7.50 Swiss Francs)
W HO/IUCN/WWF Guidelines on the Conservation of Medicinal Plants *, ** (ISBN 2 8317 0136 8), IUCN, Gland,Switzerland, 1993
Report of the Consultation on AIDS and Traditional Medicine: Prospects for Involving Traditional Health Practitioners
( F rancistown, Botswana, 23-27 July 1990), WHO/TRM/GPA/90.1, WHO Geneva, 1990
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J an 2010 Dr Ajmal Nasir
ajmalnasir@hotmail.com.
Quality control of Herbal medicines
Guidelines
W HO monographs on selected medicinal plants (3 volumes) (ISBN 92 4 154517 8),WHO Geneva, 1999 (92 Swiss Francs)
Quality control methods for medicinal plant materials (ISBN 92 4 154510 0), WHOGeneva, 1998 (35 Swiss Francs)
Basic tests for drugs: pharmaceutical substances, medicinal plant materials and dosage forms (ISBN 92 4 154513 5), WHO Geneva, 1998 (26 Swiss Francs)
Guidelines for the Appropriate use of Herbal Medicines (ISBN 92 9061 124 3), WHORegional Publications, Western Pacific Series No. 23, WHO Regional Office for theWestern Pacific, Manila, 1998 (7.50 Swiss Francs)
Regulatory Situation of Herbal Medicines: a worldwide review , WHO/TRM/98.1,WHO Geneva, 1998
Good manufacturing practices: supplementary guidelines for the manufacture of
herbal medicinal products *, **, Annex 8 of (ISBN 92 4 120863 5), WHO TechnicalReport Series, No. 863, WHO Geneva, 1996 (35 Swiss Francs) ± these guidelines arealso included in Quality Assurance of Pharmaceuticals: A compendium of guidelinesand related materials, Volume 2, Good manufacturing practices and inspection.
The International Pharmacopoeia , Third Edition Volumes 1, 2, 3, 4
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J an 2010 Dr Ajmal Nasir
ajmalnasir@hotmail.com.
Global a s well a s lo cal
Quali ty Compe ti tion .
CHALLANG ES
Emerging Guideline s.
Re stri cted Marke ts.
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J an 2010 Dr Ajmal Nasir
ajmalnasir@hotmail.com.
RECOMMENDATIONS
A concerted effort by Manufacturers
and Regulators.
Standardization of Preparations
and Herbs.
Q.C methods for Herbs.
Awareness among growers and
Collectors.
8/8/2019 cGMP and it’s Importance in Herbal Preparations 2010.
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J an 2010 Dr Ajmal Nasir
ajmalnasir@hotmail.com.