What is CGMP certification ?

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. 

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 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.

Process to obtain CGMP Certification

  • Contact IAS by sending the Application Form and call us for a discussion and we are here to guide you in getting ISO CGMP certification.
  • Make your Organization ready for certification by implementing and practice the standard, monitored and continually improved.
  • Majorly, the process of ISO certification includes 2 stages

                       Stage 1Audit : Readiness Audit

                       Stage 2 Audit : Verifying the effectiveness of the System

  • The organization applying for ISO certification will be audited based on an extensive sample of its sites, services, process, products & functions.
  • Any deviation is observed during the audit, deviation report will be submitted along with the detailed audit report. According to the grading of the deviations IAS determines the time required for its closure including the correction and corrective actions which has to be approved by IAS. After the effective closure of Non conformity, the Certificate is issued limiting to the scope that was audited.

 

 certificacion gmp