Good Manufacturing Practice (GMP):
Good Manufacturing Practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards.
However, the main purpose of Good Manufacturing Practice (GMP) is always to prevent harm from occurring to the end user. ensuring the end product is free from contamination, that it is consistent in its manufacture, It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. These GMP guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly.
The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. Good Manufacturing Practice (GMP) covers all aspects of production; that its manufacture has should be well documented from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, that the product has been checked for quality more than just at the end phase written procedures are essential for each process that could affect the quality of the finished product. Every time a product is made, There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process and Good Manufacturing Practice (GMP) is typically ensured through the effective use of a Quality Management System (QMS).
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.
WHO (Later ICH also) has established detailed guidelines for Good Manufacturing Practice (GMP).
Many countries have legislated that manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation based on WHO and ICH GMP. Others have harmonized their requirements and following GMP guidelines.
Good Manufacturing Practices (GMP), along with Good Agricultural Practices (GAP), Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), are overseen by regulatory agencies in the United Kingdom, United States, Canada, Europe, China, India and other countries.
Good Manufacturing Practice (GMP)