MET Institute of Pharmacy, India
Title: Current GMP guidelines
Abha Doshi is a Principal of MET Institute of Pharmacy, Mumbai, India. She has 20 years of teaching and administrative experience and 3 year of industrial experience in production in Ranbaxy Laboratories Ltd. She has guided many MPharm students and presented research work in various national and international conferences. She has published many research articles in national and international journals.
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. These are the system to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process every time a product is made. Many countries have formulated their own requirements for GMP based on WHO GMP guidelines. GMP is referred to as cGMP mostly in United States of America which refers to current good manufacturing practice. The current GMP guidelines are formulated with continuous improvement and addition in the recent past. These guidelines provide minimum requirement that a pharmaceutical or a food product manufacture must meet to assure that the products are of high quality and do not pose any risk to the consumer or public. These requirements concern methods, equipment or testing which are used for the production, processing, packaging and/or storage of drugs. This ensures that medicine products fulfil the necessary quality criteria. Good quality must be built-in during the manufacturing process; it cannot be tested into the product after wards. Current GMP is designed to ensure that mistakes do not occur again. Systems and equipment which are used to prevent contamination mix ups and error, which may have been top of the line 20 years ago, may be less than adequate by today’s standard. There has to be continuous improvement and updating in the systems, procedures and software’s from time to time by the company. It will be dealt in detail in the talk.