Here we will provide International pharmaceuticals GMP and cGMP Guidelines like USFDA cGMP, ICH GMP, WHO GMP etc. We will also provide important GMP guidelines from India (Schedule M).
GMP refers to the Good Manufacturing Practice. GMP covers all aspects that could affect the quality of the finished product ( drug). USFDA maintain GMP guidelines as cGMP, which stands for current good manufacturing practice.
GMP Guidelines covers in detail all process of production, record keeping, raw materials, premises, equipment, packaging and personnel etc. It signifies that pharmaceutical company must keep upgrading itself with modern technology, equipment etc.
Most Important GMP guidelines around the world are following
An company desirous of exporting pharmaceutical products to USA or manufacturing in USA must ensure that its facilities get USFDA approval. USFDA cGMP guidelines along-with ICH GMP guidelines can be followed to ensure the compliance.
FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
You can view and download US FDA Pharmaceuticals GMP guidelines from below links:
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. It seeks harmonization in regulatory guidelines of different countries i.e Europe, USA and Japan. Also applies in other countries (e.g., Australia, Canada, Singapore) which adopt ICH guidelines for the manufacture and testing of active raw materials
The ICH health topics are divided into the four categories. Quality Guidelines Safety Guidelines Efficacy Guidelines and Multidisciplinary Guidelines. Quality Guidelines are concerned with the GMP requirements.
The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over 100 countries worldwide, primarily in the developing world. Many more countries have adopted its provisions and approach in defining their own national GMP requirements. The WHO GMP continues to be used as a basis for the WHO Certification Scheme and prequalification of vaccines for procurement by UN agencies.
The European Medicines Agency (EMA) and the United States FDA have fully implemented the Mutual Recognition Agreement beginning July 11, 2019. This agreement allows the European member states and the FDA to rely on each other’s GMP inspections of pharmaceutical manufacturers.1
In June 2017, the EU commission confirmed that the US FDA has the capability to carry out GMP inspections at a level equivalent to the European Union. The FDA confirmed the capability of the following EU member states to carry out GMP inspections equivalent to the level of FDA:2
Schedule M In India
Schedule M of drugs and cosmetics rules define the GMP requirements in India for pharmaceuticals. Schedule M Defines GMP requirements for various dosage forms of Allopathic medicines.
The ministry of health has decided to revise regulations pertaining to manufacturing practices under Schedule M of the Drugs and Cosmetics Rules of 1945 to make them on par with the World Health Organisation good manufacturing practice (WHO-GMP) standards.
More International GMP Guidelines
Above we have already provided most used international Pharmaceutical GMP and cGMP Guidelines. Below we are providing GMP guidelines from more countries.
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