What is Good Manufacturing Practice GMP?

What is good manufacturing practice gmp

 

This article explains what is the Good Manufacturing Practice GMP. The GMP regulations are intended to maintain the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations that may affect the patients or their caregivers.

The Good Manufacturing Practice GMP is a set of government regulations, rules, and laws, enforced by the Food and Drugs Administration FDA in the United States.  It is important to note that the GMP’s requirements are mandatory.  Its implementation is the responsibility of each manufacturer.  Keep in mind that the Good Manufacturing Practice GMPs are not guidelines or recommended practices.

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.

They are included in VOLUME 21–FOOD AND DRUG for the nine (9) types of industries that may want to distribute and sell their products in the United States.   The top nine (9) types of industries that the FDA enforce the GMPs are:

  1. Pharmaceutical Drugs
  2. Radiation Emitting
  3. Cosmetics
  4. Medical Devices
  5. Biological
  6. Dietary Supplements
  7. Foods and Beverages
  8. Animal and Veterinary
  9. Vaccines and Blood

The following table describes some of the applicable codes of federal regulations for each type of industry.

APPLICABLE INDUSTRIES

GMP CODES OF FEDERAL REGULATIONS AND TITLE DESCRIPTION
1. PHARMACEUTICAL DRUGS 21 CFR Part 211 – CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

21 CFR Part 210. – CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS;

2. RADIATION EMITTING

21 CFR Part 211 – CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

21 CFR Part 212 – CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS

3. COSMETICS

21 CFR Part 211 – CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

21 CFR Part 212 – CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS

4. MEDICAL DEVICES

21 CFR Part 820 – QUALITY SYSTEM REGULATION

5. BIOLOGICAL

21 CFR Part 600 –  BIOLOGICAL PRODUCTS: GENERAL

21 CFR Part 606 –  CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS

6. DIETARY SUPPLEMENTS

21 CFR Part 110 – CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

21 CFR Part 111 – CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

7. FOODS AND BEVERAGES

21 CFR Part 110 – CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

8. ANIMAL AND VETERINARY

21 CFR Part 225 – CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

21 CFR Part 226 – CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES

9. VACCINES AND BLOOD

21 CFR Part 600 –  BIOLOGICAL PRODUCTS: GENERAL

21 CFR Part 606 –  CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS

Many countries have legislated that manufacturers follow GMP’s procedures and create their own GMP guidelines that correspond with their legislation.  GMP’s is typically ensured through the effective use of a Quality Management System (QMS).

The main purpose of GMP’s is always to prevent harm from occurring to the patient and end-user ensuring 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.

Good manufacturing practices are intended to safeguard the health of consumers and patients as well as producing quality products. In the United States, a food or drug may be deemed “adulterated” if even it has passed all of the specifications tests but is found to be manufactured in a facility or condition which violates or does not comply with current good manufacturing guideline.

GMP’s are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP’s requirements. It is the company’s responsibility to determine the most effective and efficient quality process that both meet business and regulatory needs.

GMP’s should not be confused with cGMP’s.

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:  What is Good Manufacturing Practice 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: What is Good Manufacturing Practice 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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