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cGMP Certification

CGMP CERTIFICATION

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.

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.
Click here, For more information on application and audit procedure

Why IAS?

  • IAS is a well established body accredited to provide ISO Certification against various ISO standards and as has a range of Product Certification which includes Kosher, Green, BRC, Gost-R, CE Marking, ROHS Malaysia.
  • IAS conducts ISO Certification audits, Product Certification and provides the service of ISO Internal Auditor Trainings, ISO Lead Auditor Trainings and ISO Foundation Training in Malaysia. All these certification and Training services by IAS for the country is managed from its office in Malaysia where it covers all the major cities such as Penang, Johor, Selangor, Kualalumpur, langkawi etc…
  • IAS Having two decades of audit experience helps to attain the certification faster.
  • Incorporated in 2006, we stand with 13 years of professional experience in the certification field.
  • IAS conducts the audits in more sensible and value added manner to benefit the clients of small, medium and large organization. Our flexible procedure is simple to understand and the services are timely and cost effective.
  • Our presence is in Singapore, Malaysia, Indonesia, India, Oman, Saudi Arabia, UAE, Qatar, Kuwait, Philippines countries with more than 6000 clients
  • We have more than 300 experienced empanelled auditors to effectively asses an organization’s conformance to various product standards.
  • IAS certification services are rendered by our skilled professionals by following industry set guidelines and norms.

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 CGMP Certification audit and discuss the audit procedure specific to your organization.
  • Understand the requirement of CGMP and Implement in your organization before going for certification. E.g. Documenting, training the staffs, 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 decision to improve the Organization 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.
To know more about the audit details. Kindly click here.
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