Professional Documents
Culture Documents
GMP
GMP
Pool of contents:
Introduction Part I Part Ia, Ib, Ic, Id, Ie, If. Part II Common Problems in GMP Execution How do GMPs of different countries compared???
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What is GMP???
GMP is the part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standard appropriate to their intended use and as required by the marketing authorization. Good Manufacturing Practices (GMPs) are regulations that describe the methods, equipment, facilities, and controls required for producing: Human and veterinary products Medical devices Processed food In short GMP makes the difference between nearly right and exactly right.
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What is cGMP???
The fact is that production is a very dynamic process--people change, machines wear down, deliveries come in that may or may not be what you ordered. This dynamic system poses some unknowns.
It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
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minimize contamination
consistent quality.
Why GMP?
To eliminate error.
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In a testing approach to establish manufacturing product quality, you must depend on some kind of measurement of selected attributes. Another problem with the testing approach is that only small samples of the products are tested and the results of those tests are extrapolated to the untested units. However, the connection may not be valid.
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EVOLUTION OF GMP
1963:- first GMP publication -USA 1971:-first revision 1978:- Major revision
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Code of Federal Regulations (CFR): The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations (sometimes called administrative law) published in the Federal Register by the executive departments and agencies of the Federal Government of the United States.
Current regulations of GMP appear in part 210 (title 21) of code of federal regulations published by USFDA.
21 Code of Federal Regulations Part 210. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs. 21 Code of Federal Regulations Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals.
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PART - I
2. 3. 4. 5. 6. 7. 8. 9.
Requirements for QA Systems Ensure products are developed correctly. Identify managerial responsibilities. Provide SOPs for production and control. Organize supply and use of correct starting materials. Define controls for all stages of manufacture and packaging. Ensure finished product correctly processed and checked before release Ensure products are released after review by authorized person Provide storage and distribution Organize self-inspection.
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Quality Audit
Detect short comings in implementati on of GMP
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It is an important part of organization's quality management system and is a key element in the ISO quality system standard, ISO 9001.
INTERNAL
EXTERNAL
REGULATORY
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Cont
personal, whereby every individual does a self-check to make sure that he/she is complying with all appropriate standards; internal audit, which should be performed by the quality assurance department as required by GMP, external audits, which can consist of an FDA audit, a consultant checking your compliance status
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All complaints thereof concerning product quality shall be carefully reviewed and recorded according to written procedures. Each complaint shall be investigated /evaluated by the designated personnel of the company and records of investigation and remedial action taken thereof shall be maintained. Reports of serious adverse drug reactions resulting from the use of a drug along with comments and documents shall be forthwith reported to the concerned Licensing Authority. There shall be written procedures describing the action to be taken, recall to be made of the defective product.
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21. Distribution Records: Records for distribution shall be maintained in a such manner that finished batch of a drug can be traced to the retail level to facilitate prompt and complete recall of the batch, if and when necessary.
22. Validation: periodic validation to ensure that they remain capable of achieving the intended results. Critical process shall be validated, prospectively or retrospectively. When any new master formula or method of preparation is adopted, steps shall be taken to demonstrate its suitability for routine processing.
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DIFFERENT
SUBPARTS
OF
PART I
PART IA: Specific requirements for manufacture of sterile products, parenteral preparations (small volume injectables and large volume parenteral) and sterile ophthalmic preparations. PART IB: Specific requirements for manufacture of oral solid dosage forms (Tablets and capsules) The general requirements as given in part-I
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PART IC: Specific requirements for manufacture of oral liquids (syrups, elixirs, emulsion, suspension) PART ID: Specific requirements for manufacture of topical products i.e. external preparation (creams. Ointments, pastes, emulsions, lotions, solutions, dusting powders and identical product.
PART IE: Specific requirements for manufacture of metered dose inhalers (MDI).
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PART IF: Specific requirements of premises, plant and materials for manufacture of active pharmaceutical ingredients (BULK DRUGS). The general requirements as given in part-I Additional requirements are as following: 1. Building and civil works 2. Utility cervices 3. Equipment design, size and location 4. In-process controls 5. Product containers and closures
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PART-2
Basic installation
30 sq. m 30 sq. m 80 sq. m 30 sq. m 30 sq. m 25 sq. m 30 sq. m 25 sq. m 20 sq. m 20 sq. m 30 sq. m
Ancillary Area
10 sq. m 10 sq. m 20 sq. m 10 sq. m 10 sq. m 10 sq. m 100 sq. m(svp) 150 sq. m (lvp) 150 sq. m 100 sq. m (lvp Packaging)
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3. Equipment:
No calibration No performance check of balance before use Rusty Parts not kept improperly
4. Laboratory Testing:
Poor reference standard keeping Poor data recording Reagent with no label
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6. Labelling:
Status not defined clearly Poor labelling control Release label not kept securely Inadequate reconciliation of batch label Defective equipment with no label
7. Validation:
Insufficient validation Insufficient raw data No validation programme
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Cont.
The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world. The European Union's GMP (EU-GMP) enforces more compliance requirements than the WHO GMP, as does the Food and Drug Administration's version in the US. Similar GMPs are used in other countries, with Australia, Canada, Japan, Singapore and others having highly developed/sophisticated GMP requirements. In the United Kingdom, the Medicines Act (1968) covers most aspects of GMP in what is commonly referred to as "The Orange Guide", because of the colour of its cover, is officially known as The Rules and Guidance for Pharmaceutical Manufacturers and Distributors.
GMPs are enforced in the United States by the FDA; within the European Union, GMP inspections are performed by National Regulatory Agencies (e.g., GMP inspections are performed in the United Kingdom by the Medicines and Healthcare products Regulatory Agency (MHRA); in Australia by the Therapeutical Goods Administration (TGA); in India and Pakistan by the Ministry of Health
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References :Good manufacturing practices for pharmaceutical. A plan for total quality control by willig. The Gazette of India .Sch M. The Theory and practice of industrial pharmacy by Lachman. Pg:- 804 www.fda.gov
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