What is CGMP?
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.
Process to obtain CGMP Certification
Stage 1Audit : Readiness Audit
Stage 2 Audit : Verifying the effectiveness of the System
Benefits of Cgmp Certification
- Enhances the food safety management system
- Increases consumer confidence in your products
- Helps to decrease operating costs due to rework and penalties due to non-compliance
- Helps boost export opportunities.
- Reduced duplication of inspections
- Cost saving
What an Organization should do to achieve certification?
- Call IAS for conducting a CGMP Certification audit and discuss the audit procedure specific to your organization.
- Understand the requirement of CGMP and Implement it in your organization before going for certification. E.g. Documenting, training the staff, practicing the system, etc
- Conduct one internal Audit program through trained Internal Auditors.
- Compile the collected data and complete the analysis.
- Conduct a Management review with the help of analyzed data and effect some decisions to improve the Organization’s performance towards company objectives & goals.
- Complete the audit successfully. (Stage 1 and Stage 2)
- Closure of Non conformance, if any.
- Collect and maintain the CGMP certificate.
- Comply with the surveillance audit yearly.
Once you successfully achieve ISO certification, you can check the status of your certificate by visiting our Certificate Search Page!
CGMP by IAS
IAS is one of a leading CGMP certification body in Malaysia and we provide the service of Various International ISO Certification & product Certification. IAS in Malaysia guides you to get compliance with CGMPand 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.