Good manufacturing practices - GMP is a group of guidelines those are regulated by WHO since 1975 throughout the world. The aim of GMP is to ensure the quality of the pharmaceutical products. Therefore, the GMP is considered as quality seal for the pharmaceutical products. The guidelines ensure the good production conditions in production area and good testing of the product in quality control. Many countries in the world adopted the GMP regulations provided by the WHO for their pharmaceutical production. Some countries developed their own GMP guidelines for pharmaceuticals but the basic concept of all GMP guideline is to produce the good quality medicines. According to GMP guidelines if any pharmaceutical product passes all specified tests produced in GMP violating manufacturing area that should not be reach in market.
Following are the basic GMP facility requirements that have to be followed by the pharmaceutical manufacturers:
• Manufacturing processes should be properly defined and controlled. All critical processes should be validated to ensure consistency of the process. Results of the validation of the processes should comply with specifications.
• Batch Manufacturing Records should be controlled, and any changes to the process should be evaluated. Changes that can have any impact on the quality of the product must be validated.
• Procedures and any instructions should be written in clear language to understand the properly.
• Personnel should be trained for production, quality control and to carry out the documentation.
• At the time of production and testing of final products, the records made manually or by instruments that provide the evidence that all the steps defined in procedures and instructions were done properly. Any deviation from the written procedure should be investigated and documented.
• Documents of manufacturing including distribution with complete history of a batch should be retained till expiry of the batch.
• A well defined procedure should be available to recalling any batch from market.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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