Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.
Why is it require:
GMP regulations address issues including recordkeeping, personnel qualifications, sanitation,
cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business. GMP is aimed primarily at diminishing the risks inherent in any production, which may broadly be categorized into two groups:
cross contamination/mix-ups and false labeling. Above all, manufacturers must not place buyers at risk due to inadequate safety, quality or efficacy for this reason, risk assessment has come to play an important role in GMP quality assurance guidelines.
GMP regulations address issues including
- Process Validation
- Complaint Handling
- Equipment Verification
- Personal Qualification
Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.
Benefits of GMP Certification:
- Operations habits
- Enable employees to develop good production
- Reduce safety risk in product quality and safety
- Enhance the international credibility and public image
- Increase customer’s long-term confidence in the enterprise
- Timely detect production and management problems, reduce cost
- Better understand and comply with the relevant laws and regulations
- Prove enterprise’s management capabilities in product quality, safety assurance