CGMP Certification

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CGMP Certification

GMP is an acronym for Good Manufacturing Practices. These are production, testing and quality control guidelines that are set up by the FDA (U.S.) or Health Canada (Canada). GMP’s are enforced in most countries around the world.

The GMP guidelines include requirements for documentation, clean rooms/equipment, personnel, quality control, production, and process controls. This is not an exhaustive list of the protocols as some countries have specific additional guidelines.
The GMP’s for a dietary supplement can be thought of as being on par with those used for pharmaceuticals. However, the GMP standards are not law even though most manufacturers follow them so you cannot necessarily hold a manufacturer to these standards in a court of law.

The reason why the GMP’s are not enforced by law is that dietary supplements are not drugs so they cannot be regulated as drugs. However, you can regulate them as if they were “foods" or “dietary ingredients." Under this consideration, it is helpful for manufacturing companies to follow the GMP guidelines in order to be in compliance with FDA regulations.

The FDA can and has inspected dietary supplement manufacturers and required them to make changes in their facilities and processes when there are violations of the GMP guidelines. These inspections can lead to removing products from store shelves or even shutting down a manufacturing building. It is important for you as a consumer to remember that GMP’s will not guarantee a safe product.

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 a 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 Certification

GMP Vs cGMP Certification

GMP and cGMP guidelines provide a framework of processes, procedures, and documentation to assure that the end product is safe for its intended use. GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff; whereas cGMP refers more specifically to the actual controls within the process such as establishing specifications and standard operating procedures, performing production and process control, testing the product to ensure it is safe for its intended use.

The two are different in that compliance with cGMPs does not ensure that products have met the appropriate GMP’s. The difference between these two concepts can be likened to providing a child care center with an acceptable cGMP inspection. The requirements for a child care center normally include items such as proper food storage, cleanliness of the facility, and appropriately trained staff. These are all important considerations that directly affect the health and welfare of children or patients who use products that require GMP’s.

The FDA does not normally inspect a product for ‘GMP compliance’ but they do enforce cGMP requirements. For example, if a dietary supplement company manufactures products for retail companies, the FDA will typically inspect the manufacturing facility to ensure that products are produced in compliance with cGMP regulations. The reason for this is simple; it is much more likely that an issue or violation of product safety would occur in the manufacturing of the product versus the quality control testing of finished goods.

The final point to consider is that all dietary supplement products must be manufactured under current Good Manufacturing Practices (cGMP) in order to meet FDA cGMP guidelines, regardless of whether or not they are included on a company’s certificate of analysis (CoA). 

Coverage of cGMP Certification and Implementation 

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, which include identity, strength, quality, and purity with Compliance regulated by the Food and Drug Administration (FDA) US.

IAS is one of the leading CGMP certification bodies in Asia and we provide the service of Various International ISO certifications & product Certifications. 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.

Process To Obtain cGMP Certification

  • It is mandatory to have a cGMP compliant Manufacturing Facility and Personnel with prior experience 
  • Perform a Risk-Based Audit of your CGMP operations 
  • Get queries resolved from the FDA on issues that are related to cGMPs 
  • Plan out corrective action for all non-compliant areas/ aspects within 90 days of audit 
  • Implement the corrective actions within 120 days of the audit 
  • Make sure it is implemented as planned and no issues are left unattended at any stage 
  • Prepare a final cGMP compliance report to summarize all aspects related to cGMP 
  • Submit the cGMP compliance report along with all certificates for audit verification to IAS 
  • Get the cGMP compliance report audited by IAS, your Authorized Certification Body (ACB) 
  • If the audit is successfully completed within 60 days of submission, you are ready for cGMP certification 
  • Receive cGMP certificate from IAS after successful completion of audit. This is your proof of cGMP compliance
  • Apply for FDA Pre-Approval Inspection (PAI) and get your manufacturing site inspected by the FDA regulators 

cGMPs are an essential requirement if you want to do business in the U.S. and avoid FDA recall and regulatory fines that can shut down a company.

Benefits Of cGMP Certification:

  • Compliance with FDA regulations and demonstrating that you care about the quality of the product 
  • Greater regulatory flexibility and freedom 
  • Improved control over operations and processes 
  • Better management controls and procedures 
  • Quality products at lower costs; reduces risk related to untested or illegal products entering the US market 

cGMP compliance is essential for any foreign manufacturer that wants to sell their product in the US.

IAS provides expert advice and guidance to help you obtain cGMP certification and comply with FDA regulations. We offer: 

  • Customization of the program to fit your specific needs and requirements 
  • Detailed documentation and audit reports 
  • 24/7 technical support 
  • Assistance in getting FDA pre-approval inspections (PAI) 

IAS is the world leader in the certification of products and management systems. We provide third-party product, system, personnel, and facility certification against relevant standards including ISO 9001:2000 for quality management systems, ISO 13485:2003 for medical devices

How to get ready for GMP Certification?

  • Identify the right cGMP standard for your product and organization 
  • Understand what is needed to achieve, maintain, and demonstrate compliance with cGMP standards 
  • Identify the appropriate management systems needed to ensure your facility, processes, products meet cGMPs requirements 
  • Ensure that personnel are fully aware of and understand their responsibilities in terms of cGMP compliance and the necessary work processes
  • Identify any current noncompliance issues with cGMPs 
  • Apply, register, get inspected by IAS for certification to the relevant standard 
  • You need expert advice from an independent third party to help you through this process. We are committed to provide your guidance and support throughout the process. We offer: 
  • Customized certification programs designed to meet your specific needs and requirements 
  • Detailed documentation and audit reports 
  • Technical support by experienced cGMP (current Good Manufacturing Practices) experts and consultants 
  • Assistance in getting FDA pre-approval inspections (PAI) 

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