Because of the thalidomide tragedy in the U.S., the FDA (FOOD AND DRUG ADMINISTRATION introduced in 1940, GMP (GOOD MANUFACTURING PRACTICES). In 1963, the World Health Assembly supported CGM and stated that all companies, factories should follow GMP. In 1978, GMP was modified to CGMP and regulated by the FDA. CGMP works to ensure a quality standard of drugs used in the U.S. From 1978 to till, it changes now every year in April CGMP, but till now, not any tremendous change is made by the FDA.
FDA GMP consultants controls pharmaceuticals activities in U.S. CGMP (CURRENT GOOD MANUFACTURING PRACTICES) are regulated by the FDA. According to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) quality standards, all pharmaceutical industries must follow GMP guidelines. CGMP consulting provides guidelines for manufacturing processes, proper design, quality standard, monitoring, durability, authenticity, the strength of pharmaceutical products. In CGMP, C- stands for current, which means technology, innovation, as per the current date. Components of CGMP
- Consistency in producing quality products
- Provides QA (quality assurance)
- It is legal
- It stands for both and quality and quantity
- As per WHO, the major role of GMP is to avoid contamination and mix up of drugs.
In 1978, GMP used traditional production methods. It was using conventional machines and huge manpower to increase the quantity of the products, and human error often was compromised the quality of the products.
When GMP is improvised CGMP, it ensures to use the more day science and technology for the production. It uses automation and instrumentation for the quality standard. In CGMP, other than GMP, one must follow the present-day innovation in the pharmaceutical industry.
CGMP guidelines are governed by 21 CFR (guidelines followed by U.S. FDA) for drug manufacturing and finished products. CFR (Code of Federal regulation published by Federal Govt. IN CFR, there are a total of 50 chapters.
Chapter 3- For U.S. president Chapter 50- For fisheries and wildlife preservation Chapter 21- Food and drug manufacturers
U.S. GMP has 3 parts. 210- It states the CGMP framework for regulations, i.e., manufacturing, processing, packing, or holding of drugs. 211- It states CGMP finished pharmaceuticals
Title 21- It has 11 subparts, A to K.
A- General provisions B- Organisation and personnel C- Building and facilities D- Equipment E- Production and process control F- Packaging and labelling control G- Holding and distribution H- Lab controls I- Records and reports J- Returned and salvaged drug products.
Merits of CGMP Guidelines
- By GMP, the quality of drugs was stagnant, but because of the implementation of CGMP, it would improve the quality of products.
- Money-saving- As in the old days, traditional methods with large no of manpower were used, which was time and money consuming, and the error by humans could not be detected. But with present technology, manpower not much required as instrumentation has covered almost all the fields.
- Less Time consumption- because of using of heavy advanced machinery.
- Ensure safety and less hazard- As implementation of fire alarm and huge usage of CCTV camera ensures the safety of human lives.
- GMP provided a working culture to follow while CGMP provides guidelines to profit the pharmaceutical industry.
- Application of Information Technology and automation increases exponentially