4. CONTENTS
Introduction
Objective
GMP guideline
WHO- GMP
US-FDA GMP
ICH GMP
MHRA
Comparison between US-FDA GMP and Indian GMP
(Schedule. M)
GMP Issue
5. INTRODUCTION
Good Manufacturing Practices (GMP) is a set of rule
for medicine manufactured to follow so that there
products are safe effective and good of quality. The
rules may be written into law or set out in guidance
documents from regulatory authority. Regulator will
not allow medicinal products to be placed, or to
remain on the market in their country unless the
product can be shown to be manufactured in
compliance with GMP.
6. OBJECTIVES
Appreciate the quality regulations pertaining to the Medical
Device industry
Understand the context of these regulations within the Quality
Management System.
Appreciate how regulations translate into day to day Good
Manufacturing Practices and SOP's.
Be familiar with the Quality System Regulations ( FDA’s cfr 820)
Understand their own role and responsibility in applying the
above regulations to their job function
Understand the role of the quality auditor
Consider what happens if personnel do not comply with
regulations from product and regulatory perspectives
Appreciate the importance of records and documentation
necessary to support a Quality System.
7. GMP GUIDELINES
GMP is part of quality assurance which ensures that
products are consistently produced and controlled to
the quality standards appropriate to their intended use
and as required by marketing authorization or product
specifications.
GMP guidelines by different governing authorities :-
ICH
US- FDA
MHRA
WHO
8. WHO – GMP
In the medicines industry at large, quality
management is usually defined as the aspect of the
management function that determines and
implements the “quality policy”, i.e. the overall
intention and direction of an organization regarding
quality, as formally expressed and authorized by top
management.
9. WHO - GMP GUIDELINE
Pharmaceutical quality system .
Good manufacturing practices for pharmaceutical
products.
Sanitation and hygiene .
Qualification and validation.
Self-inspection, quality audits and suppliers’ audits
and approval.
Good practices in production.
Good practices in quality control
10. US-FDA GMP
The Food and Drug Administration (FDA or
USFDA) is a federal agency of the United States
Department of Health and Human Services, one of the
United States federal executive departments. The FDA
is responsible for protecting and promoting public
health through the regulation and supervision of food
safety, drugs , vaccines , biological product.
11. US- FDA REGULATES
Foods, including :
Dietary supplement
Bottled water
Food additives
Infant formulas
Drug, including.
Prescribed drugs (both brand name and generic)
Non prescribed (over the counter) drug
Biological, including
Vaccines
Blood and blood product
Cellular and gene therapy product
Tissue and tissue product
Cosmetic, including
Color additives found in make up and other personal care product
Skin moisturizer and cleansers
Nail polish and perfumes
12. ICH - GMP
The International Council on Harmonisation of
Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH) is a project
that brings together the regulatory authorities of
Europe, Japan and the United States and experts from
the pharmaceutical industry in the three regions to
discuss scientific and technical aspects of
pharmaceutical product registration
14. GMP Issue
Quality
Consistency
Adequate Space
Product Protection
Proper Support Areas
Clean ability
Water Quality
Power
15.
16. CONTENT
Introduction
Importance
Validation consideration situation
types of validaion
Phases of validation
Blueprint of validation
Organistion for validation
Regulation of Validation
Validation report
17. IMPORTANCE
1. Assurance of quality
2. Time bound
3. Process optimisation
4. Reduction of quality cost.
5. Nominal mix-ups,and bottle necks
6. Minimal batch failures, improved efficiently and
productivity.
7. Reduction in rejections.
8. Increased output.
9. Avoidance of capital expenditures
10. Fewer complaints about processrelated failures.
11. Reduced testing in process and in finished goods
18. VALIDATION CONSIDERATION
SITUATION
Totally new process;
New equipment;
Process and equipment which have been altered to suit
changing priorities; and
Process where the end-product test is poor and an
unreliable indicator of product quality.
20. PHASES IN PROCESS VALIDATION
Phase 1 :
Pre-validation phase or the Qualification phase, which covers all
activities relating to product research and development, formulation,
pilot batch studies, scale-up studies, transfer of technology to
commercial scale batches, establishing stability conditions, storage and
handling of in-process .
Phase 2 :
Process validation phase Operational (Process Qualification phase)
designed to verify that all established limits of the critical process
parameters are valid and that satisfactory products can be produced
even under the “worst case” conditions.
Phase 3 :
Validation Maintenance phase requiring frequent review of all process
related documents, including validation audit reports to assure that
there have been no changes, deviations, failures, modifications to the
production process.
21. BLUEPRINT FOR VALIDATION OF
METHODS
Develop a validation protocol or operating procedure for
the validation;
Define the application purpose and scope of the
method;
Define the performance parameters and acceptance
criteria;
Define validation experiments;
Verify relevant performance charact-eristics of the
equipment;
Select quality materials, e.g., standards and reagents;
22. ORGANISATION FOR VALIDATION
Quality Assurance Committee
(Head of quality control/quality assurance,
Production, Engineering and GMP section)
Validation Steering Committee
(Members represent the above departments)
Validation Team
(Those responsible from Quality control, production
and engineering)
23. REGULATIONS OF VALIDATION
Quality assurance
Quality variations among units within a batch, or among different
batches, are seldom detected by testing of finished product samples
Economics
The direct economics benefit of validation is a reduction in the cost
associated with process monitoring, sampling and testing.
Compliance
Specific current Good Manufacturing Practices (cGMP) references
to variation are found in following sections of 21CFR211
211.884(d) - Variation of suppliers test result for components
when these results are accepted in lieu of in-house testing after receipt.
211.165(e) - Validation of analytical methodologies. The
requirement of validation is also implied in 211.100(a).
24. VALIDATION REPORT
A written report should be available after completion of the
validation. If found acceptable, it should be approved and
authorized (signed and dated). The report should include at
least the following:
Title and objective of study;
Reference to protocol;
Details of material;
Equipment;
Programmes and cycles used;
Details of procedures and test methods;
Results (compared with acceptance criteria); and
Recommendations on the limit and criteria to be applied on
future basis.
25. REFERENCES
Pharmaceutical Press. "Rules and Guidance for Pharmaceutical Manufacturers and Distributors - Edition:
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"FDA Issues Dietary Supplements Final Rule" (Press release). U.S. Food and Drug Administration.
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Good Manufacturing Practices (GMP) for Pharmaceutical product ; WHO Expert Committee on
specification for pharmaceutical preparation Forty Eight report , Annex 2 , WHO Technical report
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Bankert, Elizabeth A; Robert J. Amdur (2006). Institutional Review Board. Jones & Bartlett Publishers.
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About www.ich.org
"About us". www.gov.uk. Medicines and Healthcare products Regulatory Agency. Retrieved 13 March
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