GMP (GOOD MANUFACTURING PRACTICE)
There are several different sections to cGMP as detailed in CFR’s so it is essential to study those applicable to your processes. i.e. Medical Device, Biotech, Human Food, or Pharmaceuticals. Most of the requirements for the Pharmaceutical branches of the industry are legal requirements, failure to comply is therefore a criminal offence and can lead to severe fines or even 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 distribution processes. Companies are required to implement processes and procedures that comply with the requirements listed in the applicable Good Manufacturing Practice (cGMP's) and gain approval from their regulatory authority that they comply with all of these regulations prior to being allowed to release their produce for public or prescribed use. They are subject to continuous monitoring of this regulated state.
GMP Enforcement. cGMP's are enforced in the United States by the US FDA, under Section 501(B) of the 1938 Food, Drug, and Cosmetic Act (21USC351). The regulations use the phrase "current good manufacturing practices" (CGMP) to describe these guidelines. Courts may theoretically hold that a drug product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards.[citation needed] By June 2010, the same CGMP requirements will apply to all manufacturers of dietary supplements.[1] The World Health Organization (WHO) version of cGMP 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 similar requirements to WHO cGMP, as does the Food and Drug Administration's version in the US. Similar cGMPs 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", which is named so because of the color of its cover; it is officially known as Rules and Guidance for Pharmaceutical Manufacturers and Distributors.[2] Since the 1999 publication of cGMPs for Active Pharmaceutical Ingredients, by the International Conference on Harmonization (ICH), GMPs now apply in those countries and trade groupings that are signatories to ICH (the EU, Japan and the U.S.), and applies in other countries (e.g., Australia, Canada, Singapore) which adopt ICH guidelines for the manufacture and testing of active raw materials.
GMP RELAXATION FOR PHASE 1 TRIALS.A year ago the FDA announce a relaxation in the continued GMP (cGMP's) 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 GMP (cGMP's) 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.
CURRENT GOOD MANUFACTURING PRcfACTICE 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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