Current Good Manufacturing Practice (CGMP) is a term that is familiar worldwide for the control and management of manufacturing, testing and overall quality control of food and pharmaceutical products. CGMP takes quality assurance approach, which ensures that the products are consistently produced and controlled to the quality standard which is appropriate to their proposed use and as required by the marketing authorization.
CGMP addresses the issues including documentation, record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most CGMP requirements are very general and open ended, allowing each manufacturer to decide how to best implement the necessary controls.
The quality approach of CGMP ensures manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn that protects the consumer from purchasing a product, which is not effective or even hazardous. Failure of firms to comply with CGMP regulations can result in very serious penalty including recall, seizure and fines.
The word “current” was added to say to companies that they need to be up to date with the latest technology rather than running on what was a good practice in the past. Pharmaceutical and biotechnology companies strictly follow CGMP processes to ensure their items are manufactured to specific requirements fulfilling the FDA regulations, that include identity, strength, quality, and purity with Compliance regulated by the Food and Drug Administration (FDA) US.
IAS is one of a leading CGMP certification body in Asia and we provide the service of Various International ISO Certification & product Certification. IAS in Asia guides you to get compliance with CGMP and provide CGMP certification.
CGMP stands for Current Good Manufacturing Practices, the name given to quality systems used by U.S. Food & Drug Administration regulated product manufacturers to ensure compliance with FDA regulations.
Stage 1Audit : Readiness Audit
Stage 2 Audit : Verifying the effectiveness of the System