cGMP, AN INTRODUCTION.
GMP refers to the FDA's "current Good Manufacturing Practice ". There are different sections to CFR’s and so a variation in cGMP’s depending on which section of the Pharma industry you are involved in. i.e. Medical Device, Biotech, Human Food, or Pharmaceuticals. Most of the cGMP requirements for the Pharmaceutical branches of the industry are legal statuary requirements, failure to comply is therefore a criminal offence and can lead to severe fines or custodial sentences. Manufacturers must adapt a very positive and proactive approach in conforming and enforcing the rules and guidelines throughout their entire manufacturing, inspecting, storing and distributed processes. Companies are required to implement processes and procedures that comply with the requirements listed in the applicable cGMP’s and pass a certification inspection of these processes and the allied documentation prior to be allowed to release their produce for public or prescribed use. They are subject to continuous monitoring of this certified state. GMP RELAXATION FOR PHASE 1 TRIALS.A year ago the FDA announce a relaxation in the continued Good Manufactuing Procedures requirements for production of drug batches for use in Phase 1 trials. The guidance relaxation only applies to Phase 1 Trials which include initial studies to determine the metabolism and pharmacological actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness. At this stage, drugs are tested in a small group of healthy volunteers to determine the drug's activity.
The move is part of the FDA's new commitment to modernise existing cGMP regulations to streamline clinical development and is part of the Agency's Critical Path Initiative, launched in March 2004, with the goal of reducing the time and resources expended on candidate products that are unlikely to succeed, by creating new tools to distinguish earlier in the process those candidates that hold promise. It is hoped that this will improve the process for bringing safe and effective drugs for potentially serious and life-threatening diseases, such as cancer, heart disease and neurological disorders to the market.
In the new guidance and an accompanying regulation, the FDA outlines a suggested approach to complying with cGMP requirements for drugs intended for use solely in phase 1 studies. In addition, the FDA formally recognizes specific standards for the manufacture of small amounts of drug product for phase 1 studies and formulating an approach to cGMP compliance that is appropriate for the particular stage of drug development. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS cGMP. Subpart A--General Provisions
211.1 - Scope. 211.3 - Definitions. Subpart B--Organization and Personnel 211.22 - Responsibilities of quality control unit. 211.25 - Personnel qualifications. 211.28 - Personnel responsibilities. 211.34 - Consultants. Subpart C--Buildings and Facilities 211.42 - Design and construction features. 211.44 - Lighting. 211.46 - Ventilation, air filtration, air heating and cooling. 211.48 - Plumbing. 211.50 - Sewage and refuse. 211.52 - Washing and toilet facilities. 211.56 - Sanitation. 211.58 - Maintenance. Subpart D--Equipment cGMP 211.63 - Equipment design, size, and location. 211.65 - Equipment construction. 211.67 - Equipment cleaning and maintenance. 211.68 - Automatic, mechanical, and electronic equipment. 211.72 - Filters. Subpart E--Control of Components and Drug Product Containers and Closures GMP 211.80 - General requirements. 211.82 - Receipt and storage of untested components, drug product containers, and closures. 211.84 - Testing and approval or rejection of components, drug product containers, and closures. 211.86 - Use of approved components, drug product containers, and closures. 211.87 - Retesting of approved components, drug product containers, and closures. 211.89 - Rejected components, drug product containers, and closures. 211.94 - Drug product containers and closures. GMP. Subpart F--Production and Process Controls 211.100 - Written procedures; deviations. 211.101 - Charge-in of components. 211.103 - Calculation of yield. 211.105 - Equipment identification. 211.110 - Sampling and testing of in-process materials and drug products. 211.111 - Time limitations on production . 211.113 - Control of microbiological contamination. 211.115 - Reprocessing. Subpart G--Packaging and Labeling Control 211.122 - Materials examination and usage criteria. 211.125 - Labeling issuance. 211.130 - Packaging and labeling operations. 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 211.134 - Drug product inspection. 211.137 - Expiration dating. Subpart H--Holding and Distribution 211.142 - Warehousing procedures. 211.150 - Distribution procedures. Subpart I--Laboratory Controls 211.160 - General requirements. 211.165 - Testing and release for distribution. 211.166 - Stability testing. 211.167 - Special testing requirements. 211.170 - Reserve samples. 211.173 - Laboratory animals. 211.176 - Penicillin contamination. GMP. Subpart J--Records and Reports GMP 211.180 - General requirements. 211.182 - Equipment cleaning and use log. 211.184 - Component, drug product container, closure, and labeling records. 211.186 - Master production and control records. 211.188 - Batch production and control records. 211.192 - Production record review. 211.194 - Laboratory records. 211.196 - Distribution records. 211.198 - Complaint files. Subpart K--Returned and Salvaged Drug Products GMP 211.204 - Returned drug products. 211.208 - Drug product salvaging.
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