WHO GMP Certification M. Mitra CDSCO(NZ)
Download
Report
Transcript WHO GMP Certification M. Mitra CDSCO(NZ)
WHO GMP Certification Scheme
M. Mitra
Former Dy. Drugs Controller (I),
CDSCO, HQ, New Delhi
Originally promugulated in 1969 and revised in
1975. Main objectives were :
WHO GMP CERTIFICATION
Guidelines be developed for official inspections
of dug manufacturing facilities
To assess compliance of GMP
This would facilitate implementation of the scheme
7/16/2015
Chennai_12
WHO GMP CERTIFICATION
With 191 countries members in the scheme a
solution was found for international commerce
between these countries. The scheme offered a
solution for those countries which did not have a
developed regulatory agency yet wanted to import
drugs.
7/16/2015
Chennai_12
7/16/2015
Chennai_12
Basic principles of WHO Good Manufacturing
WHO GMP CERTIFICATION
Practice is similar to any established GMP
requirement. Allied documents like Schedule M,
CFRs, ASEAN GMP, etc are all similar in nature.
Anyone following any established GMP procedure
will automatically understand the principles in the
other GMP requirements.
7/16/2015
Chennai_12
WHO GMP requirements have been developed
taking into account the principles in various
GMP texts and also considering the requirements
of developing countries. These requirements are
not for domestic use but for international trade.
WHO GMP CERTIFICATION
7/16/2015
Chennai_12
There are around 1000 (?) WHO GMP certified manufacturing
establishments in the country, with West Zone leading followed
by the South, North and the East Zones.
New Applications are coming in everyday due to increase in
exports of drugs, India being a major exporter of Drugs &
Pharmaceuticals Globally.
Other purchasers like the State governments, ESI etc. have also
started (erroneously) asking for the certificates as preconditions.
WHO GMP CERTIFICATION
7/16/2015
Chennai_12
WHO GMP ensures the following:
Avoidance of Cross- Contamination
Prevention of Mix-ups
Provide Traceability
Accountability of actions
Responsibility
Product Performance Guarantee
7/16/2015
Chennai_12
WHO GMP CERTIFICATION
WHO GMP CERTIFICATION
Understanding WHO GMP
Documents and Literature
7/16/2015
Chennai_12
A series of reports known as the WHO
Technical Report Series (TRS) are available.
7/16/2015
WHO GMP CERTIFICATION
TRS 823 (1992)
TRS 834 (1993)
TRS 863 (1996)
TRS 885 (1999)
TRS 902 (2002)
TRS 908 (2003)
TRS 917 (2004)
TRS 929 (2005)
TRS 937 (2006)
Chennai_12
Other documents
A WHO Guide to Good Manufacturing Practice
(GMP) Requirements (WHO/VSQ/97.02) (for
validation)
WHO GMP CERTIFICATION
7/16/2015
Chennai_12
7/16/2015
Chennai_12
Various other documents are available
with WHO which is freely available for
users. WHO website is the best source
for getting information. Similarly
documents of other established
Regulatory agencies can expand
knowledge and understanding
WHO GMP CERTIFICATION
7/16/2015
Chennai_12
Issue of Certificates
What are the Certificates?
Three types of Certificates are recommended
by the WHO.
WHO GMP CERTIFICATION
These are:
1) Product Certificate (COPP)
(TRS 823, 863)
2) Statement of Licensing Status (TRS 823, 863)
3) Batch Certificate
(TRS 823, 863)
There is another Certificate – Site Certificate.
Described later
7/16/2015
Chennai_12
The member state shall attest the following
conditions of a manufacturer if required to
attest a product for the certification:
A specific product is authorized to be placed
in the market of the exporting country, if not
why not
The manufacturing plant is subject to regular
inspections for WHO GMP compliance
All product information, including labeling is
currently authorized in the certifying
country.
WHO GMP CERTIFICATION
1.
2.
3.
7/16/2015
Chennai_12
Conditions to be satisfied before opting for
the scheme by any member country
WHO GMP CERTIFICATION
Effective national licensing system for products,
manufacturers and distributor
Effective control of quality of products, including
independent laboratory
A technically competent, experienced, resourceful National
Pharmaceutical inspectorate, as part of NDRA having legal
powers for investigations
Administrative capacity to issue Certificates and quickly
notify WHO and other member countries
7/16/2015
Chennai_12
Understanding the Technical Report Series
TRS 823 – Salient features
WHO GMP CERTIFICATION
PART I Quality Management in the Drug Industry –
Philosophy & Essential Elements
Quality Assurance
Good Manufacturing Practice
Quality Control
Sanitation & Hygiene
Validation
Complaints
7/16/2015
Chennai_12
PART I contd.
Product recalls
Contract Production & Analysis
Self-inspection and quality audits
Personnel (including key personnel)
Equipment
Premises
Material
Documentation
7/16/2015
Chennai_12
WHO GMP CERTIFICATION
PART II : Good Practices – Production &
Quality Control
Good Practices in Production
Includes General requirements, prevention of cross
contamination and bacterial contamination, processing
operations, packaging operations
Good Practices in Quality Control
Control of starting material and intermediate, bulk, and
finished products, test requirements, production record review,
stability studies
7/16/2015
Chennai_12
WHO GMP CERTIFICATION
PART III: Supporting and Supplementary
Guidelines
Sterile pharmaceutical Products
WHO GMP CERTIFICATION
General requirements (air classifications), manufacture of sterile preps, personnel,
premises, equipment, sanitation, processing, sterilization, filtration, finishing,
quality control,
Good Manufacturing Practice for Active
Pharmaceutical Ingredients
Explanation, general considerations, personnel, premises, equipment, sanitation,
documentation, retention of records and ref samples, production,
Form and content of inspector’s report
Validation of analytical procedures
A Model Certificate Format is also presented
7/16/2015
Chennai_12
TRS 863 – Salient features
Useful guidelines:
Guidelines for Stability Testing
Guidelines for Validation
Import Procedure for Drugs
Guidelines for implementation of the Scheme
(including model certificate)
Guidelines on import procedures for
pharmaceutical products
WHO GMP CERTIFICATION
7/16/2015
Chennai_12
TRS 885 – Salient features
GMP – Authorised Persons - Role, Functions &
Training
WHO GMP CERTIFICATION
Role and position of authorized person, implementation of the quality
system, education and training., routine duties of an authorized person,
GMP – Supplementary Guidelines for the
Manufacture of Pharmaceutical Excepient
General considerations, self inspection and quality audits, use of
equipment, cleaning programme, starting material, rejected and
recovered materials, returned excepients, storage practices, specifications,
BPRs, change control and process validation, prevention of cross
contamination, blending, microbial contamination, water systems,
packaging, quality control etc.
7/16/2015
Chennai_12
TRS 902 – Salient features
WHO GMP CERTIFICATION
Good Practices for National Control
Laboratories
Basic elements of GMP (definition)
GMP for Sterile Products – revision
Inspections
National GMP Inspectorate
Guidelines on Packaging of Pharmaceutical
Products
Storage areas
Labels
7/16/2015
Chennai_12
TRS 908 – Salient features
GMP for radio pharmaceuticals
WHO GMP CERTIFICATION
GMP for Pharmaceutical Products
Main principles
HACCP
Guidance on GMP: Inspection report
Guide to good storage practices for
pharmaceuticals
Model Certificate of a Pharmaceutical Product
Site Certificate – does not replace the Product
certificate
7/16/2015
Chennai_12
TRS 917 – Salient features
WHO GMP CERTIFICATION
Active Pharmaceutical Ingredients
API
Herbal
7/16/2015
Chennai_12
TRS 929 – Salient features
Concept of sampling of starting materials
Heating ventilation and air conditioning
Validation
Water for pharmaceutical use
..\GMP matters\WHO_TRS_929.pdf
7/16/2015
Chennai_12
TRS 937 – Salient features
One of the most important TRS
Supplementary guidelines on GMP for HVAC
(Supplementary guidelines on GMP for Herbals)
Supplementary guidelines on GMP : Validation
HVAC Water Systems
Cleaning
Analytical Method
Computerized Systems
Qualification of systems and equipment
Non-sterile process validation
Good Distribution Practices for pharmaceutical products
7/16/2015
Chennai_12
WHO GMP CERTIFICATION
How to Certify a Product
Certification of
products are done after
thorough examination of the product and the
facilities where these are manufactured
7/16/2015
Chennai_12
How to Certify a Product
WHO GMP CERTIFICATION
The facilities are Inspected NRA
Inspectors with good knowledge of
GMP
The inspection may take two or more
days
Certificates are issued by the Issuing
Authority on the recommendation of
the joint report
7/16/2015
Chennai_12
Requirements
Procedures Main Requirements
Product
B. Procedures
C. Facilities
A.
7/16/2015
Chennai_12
WHO GMP CERTIFICATION
Requirements
WHO GMP CERTIFICATION
A. Product
The basic requirements of the product
are:
1.
2.
3.
7/16/2015
Product design
Stability Studies
Process validation
Chennai_12
Requirements
WHO GMP CERTIFICATION
B. Procedures
All actions taken in the facility
which leads to the production of
the final product as per
specification.
7/16/2015
Chennai_12
Requirements
WHO GMP CERTIFICATION
C. Facilities
This encompasses the building, machinery,
services and utilities, manpower etc. These are
guided towards making a properly designed
product.
7/16/2015
Chennai_12
7/16/2015
Chennai_12
7/16/2015
Chennai_12
7/16/2015
Chennai_12
7/16/2015
Inspection Points
1. Quality Management
2. Sanitation and hygiene
3. Validation
4. Complaints and recalls
5. Contract production and analysis
6. Self Inspection
7. Personnel
Chennai_12
WHO GMP CERTIFICATION
Discussions:
8. Premises
9. Equipment
10. Materials
11. Documentation
12. Sterile production
13. Active pharmaceutical ingredients
7/16/2015
Chennai_12
WHO GMP CERTIFICATION
GMP consists of various activities which an be
grouped together as follows:
WHO GMP CERTIFICATION
1.
Training - induction, ongoing, refresher etc.alonwith such
documents like SOP, training calendar, assessment
etc.
2.
Cleaning sanitation and hygiene - may also include
workers entry procedure, cleaning of the
premises etc
3.
Validation and calibration - qualification of machinery,
4.
Storage - apart from normal ware-housing facilities, this
equipment etc.
should also address quarantine, procedure Etc.
7/16/2015
Chennai_12
5.
movement of manpower, material - uni-flow
movement,
movements control etc.
6.
7.
8.
Quality assurance –
Quality control
Documentation - must include MFR, BPR, SOP Documents
control & distribution, cleaning, training,
document regulating and recording
activities
and
other
Change control –
10. Self inspections and audits
9.
7/16/2015
WHO GMP CERTIFICATION
Chennai_12
Usual Problems faced by Regulatory Agencies:
Fund problems
WHO GMP CERTIFICATION
Lack of knowledge on the part of applicants
Lethargic mindset
Back to original condition after Certification
Usual Problems faced by applicants:
Sometimes lack of Knowledge on the part of
auditors
Teacher as well as Examiner status
Lack of time for thorough auditing
7/16/2015
Chennai_12
Useful Web Sites:
http://www.who.int/en/
http://www.who.int/bookorders/anglais/
subscription1.jsp?sesslan=1
http://www.who.int/medicines/organization/
qsm/activities/qualityassurance/gmp/gmpcove
r.html
http://www.fda.gov/
http://www.health.gov.au/tga/docs/html/gmph
ome.htm
http://www.mca.gov.uk/
WHO GMP CERTIFICATION
7/16/2015
Chennai_12
M. Mitra
Former Dy. Drugs Controller (India),
CDSCO
(M) 9716755102
Email : [email protected]
7/16/2015
Chennai_12
WHO GMP CERTIFICATION
7/16/2015
Chennai_12