Good Manufacturing Practices
GMP, also known as cGMP, stands for current Good Manufacturing Practices, and is a set of regulations set forth by the U.S. Food and Drug Administration (FDA) to help ensure that various products intended for human consumption and use are safe and effective.GMP is part of a quality system covering the manufacture and testing of pharmaceutical dosage forms or drugs and active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries now require that pharmaceutical and medical device companies must follow GMP regulations, and have created their own GMP guidelines
Principles Of Good Manufacturing Practices :-
- Design and construct the facilities and equipments properly.
- Follow written procedures and Instructions.
- Document work.
- Validate work.
- Monitor facilities and equipment.
- Write step by step operating procedures and work on instructions.
- Design ,develop and demonstrate job competence.
- Protect against contamination
- Control components and product related processes.
- Conduct planned and periodic audits.