Current Good Manufacturing Practice (CGMP)

• Indian government is exploring the feasibility of establishing WHO-approved Current Good Manufacturing Practice (CGMP) facility for yellow fever drugs.
• Such a facility will help in supplying yellow fever vaccine to African and Latin American countries as well.
• Indian government has launched its first facility for CGMP compliance for DPT(diphtheria, pertussis, and tetanus) and TT vaccines(tetanus toxoid) is inaugurated at the Central Research Institute (CRI) in Kasauli in Himachal Pradesh.
• CRI is involved in manufacture and supply of various life-saving therapeutic anti-sera for snake bites, rabies and diphtheria and yellow fever vaccine.
• A consumer usually cannot detect that a drug product is safe or if it will work.So, it is important that drugs are manufactured under conditions and practices required by the CGMP regulations to assure that quality is built into the design and manufacturing process at every step. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how CGMP requirements help to assure the safety and efficacy of drug products.

About Current Good Manufacturing Practice (CGMP)

• Good Manufacturing Practices (GMP, also referred to as 'cGMP' or 'current Good Manufacturing Practice') is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
• GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals including vaccines.
• GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints.
• Specific GMP requirements relevant to classes of products such as sterile pharmaceuticals or biological medicinal products are provided in a series of annexes to the general GMP requirements
• The first WHO draft text on GMP was adopted in 1968. In 1969, when the World Health Assembly recommended the first version of the WHO Certification Scheme on the quality of pharmaceutical products moving in the global market, it accepted the WHO GMP as an integral part of the Scheme. A supplementary annex on biological medicinal products was adopted by the Expert Committee on Biological Standardization (ECBS) in 1991 and establishes the general approach to the quality control of biological medicines that include products such as vaccines, blood and blood products, antigens, cell and tissue therapies, biopharmaceutical products, and others.
• More than 100 countries have incorporated the WHO GMP provisions into their national medicines laws, and 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.

By: Vishal