Difference between GMP & current Good Manufacturing Practices cGMP

current Good Manufacturing Practices cGMP versus GMP

 

current Good Manufacturing Practices cGMP versus GMP

Since the GMP’s are revised and updated annually in the United States, the most recent version is called the current Good Manufacturing Practices, (cGMP’s).

The “c” in GMP’s just means “current” revision.  The regulations require that manufacturers follow the current Good Manufacturing Practices cGMP.  The “current” in front of that just acknowledges that what is considered ‘actual, effective, improved’ over time.  Typically, each year the FDA expects companies to continually improve and implement the most recent regulatory changes in their facilities bringing training to their employees annually in the updates procedures and standards.

Following these practices ensures that the end product is completely safe for human use and consumption. It also means that the products are efficacious and pure, without any errors or contaminations.

For the medical devices industry, the current good manufacturing practices cGMP’s requirements are described in Volume 21 of the Code of Federal Regulations Part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act). Refer to https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820

For the Pharmaceutical industry, the cGMP requirements are described in Volume 21 of the Code of Federal Regulations Part 210 and 211 (21 CFR part 210 and 211).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=210

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211

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Quality procedures templates

Three (3) Options to Create Quality Management Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the quality procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill and adapt to your specific needs.

Silver Option. We Can Bring You a Formal Training on the current Good Manufacturing Practices cGMP.

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality System Procedures as per current Good Manufacturing Practices cGMP.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

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REFERENCES:

https://www.fda.gov/files/drugs/published/Overview-of-Quality-System-Regulation.pdf

https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/medical-devices-current-good-manufacturing-practice-cgmp-final-rule-quality-system-regulation

https://ispe.org/initiatives/regulatory-resources/gmp

https://www.fda.gov/media/73141/download

Food and Drug Administration References

  1. Glossary of Computerized System and Software Development Terminology (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, FDA 1995)
  2. General Principles of Software Validation; Final Guidance for Industry and FDA Staff (FDA, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, 2002)
  3. Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices (FDA, Center for Devices and Radiological Health, 1999)
  4. Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach; A Science and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems ApproachExternal Link Disclaimer (FDA 2002)
  5. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
  6. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1

Industry References: current Good Manufacturing Practices cGMP

  1. The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems, GAMP 4 (ISPE/GAMP Forum, 2001) (http://www.ispe.org/gamp/)
  2. ISO/IEC 17799:2000 (BS 7799:2000) Information technology – Code of practice for information security management (ISO/IEC, 2000)
  3. ISO 14971:2002 Medical Devices- Application of risk management to medical devices (ISO, 2001)
Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!

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