Why is the cGMPs enforced by FDA?

cGMPs enforced by FDA

 

This article describes why is the Current Good Manufacturing Practices cGMPs enforced by FDA.

Due to some mistakes in the manufacturing process that caused several dead time-ago, the USA government created legislation and an enforcement agency (FDA) to make sure that the products are safe and secure for the patients.

Current Good Manufacturing Practices (cGMPs) are the effective rules required in order to comply with the government enforcement agencies (e.g. FDA, etc.) that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices in the interstate commerce. These rules are law enforced to ensure that the minimum requirements that a manufacturer shall meet to guarantee that their products are consistently high in quality, from batch to batch, for their intended use.

The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end-user.  GMP’s are intended to ensure the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel is well trained, and the product has been checked for quality more than just at the end phase. Moreover, GMP is typically ensured through the effective use of a Quality Management System (QMS) to make sure that the product is validated and made in a clean and appropriate facility qualified.

 In the United States, the GMPs has revised annually. So, it is important to always refer to and use the actual version of the GMP, called current Good Manufacturing Practices (cGMP). The GMP consist of several volumes and parts of a federal law called Code of Federal Regulations (CFR) which are grouped and segregated by the type of business.

Good manufacturing practices, along with good agricultural practices, good laboratory practices, and good clinical practices, are overseen by regulatory agencies in the United Kingdom, United States, Canada, Europe, China, India, and other countries.

Code of Federal Regulations (CFR).  FDA’s portion of the CFR is in Title 21, which interprets the Federal Food, Drug and Cosmetic Act and related statutes, including the Public Health Service Act. The pharmaceutical or drug quality-related regulations appear in several parts of Title 21, including sections in parts 1-99, 200-299, 300-499, 600-799, and 800-1299.

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Quality procedures templates

Three (3) Options to Create Quality Management Procedures following the Good Manufacturing Practices GMP:

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 Good Manufacturing Practices GMP.

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 Good Manufacturing Practices GMP.

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: cGMPs enforced by FDA

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: cGMPs enforced by FDA

  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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