All You Need to Know About Good Manufacturing Practices GMPs

All You Need to Know About Good Manufacturing Practices

 

What are Good Manufacturing Practices GMP’s?

The Good Manufacturing Practice GMP is a set of government regulations and laws, enforced by the Food and Drugs Administration FDA in the United States.  It provides the principles to make the industry operations, testing, and quality assurance in order to ensure that a manufactured product is safe, effective, reliable, and secure for human consumption or use.

The Good Manufacturing Practices GMPs are divided into several parts called the Code of Federal Regulations CFR. (e.g. Part 211, for pharmaceutical drugs industries, etc)  These rules are published in the Federal Register by the Executive departments and agencies of the Federal Government.  Read more

What is the difference between the current Good Manufacturing Practices (cGMP’s) GMP versus cGMP?

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.  The regulations require that manufacturers follow Good Manufacturing Practices GMP.  The “current” in front of that just acknowledges that what is considered ‘actual, effective, improved’ over time.  Read more

For the medical devices industry, the 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

When are the GMP’s applicable?

Applicability

These principles are applicable to the companies involved in the manufacturing process, from raw materials to storage and transport, of food items, drugs, and medical devices. In addition to processes, Good Manufacturing Practices GMP’s also applies to the involved buildings and facilities, staff, and pieces of equipment.  Read more

What topics are covered by the cGMP?

The Good Manufacturing Practices GMP’s regulation is divided into six (6) main elements:  Read more

  • Materials,
  • Buildings,
  • Equipment,
  • Records,
  • Procedures

Why is the Good Manufacturing Practices cGMP’s enforced by the 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 (cGMP’s) 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.  Read more

Statutory and Regulatory Requirements:

Good Manufacturing Practices GMP

The QS regulation applies to finished device manufacturers who intend to commercially distribute medical devices. A finished device is defined in 21 CFR 820.3(l) as any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

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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:  Good Manufacturing Practices GMP

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: Good Manufacturing Practices GMP

  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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