Good manufacturing practice

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Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5] These guidelines provide minimum requirements that a manufacturer must meet to assure 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. [2] Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and the product has been checked for quality more than just at the end phase. [2] GMP is typically ensured through the effective use of a quality management system (QMS). [1] [2]

Contents

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.

High-level details

Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use. Many countries have legislated that manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.

All guideline follows a few basic principles [2] [6] :

Good manufacturing practices are recommended with the goal of safeguarding 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 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 guidelines 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 requirements. It is the company's responsibility to determine the most effective and efficient quality process that both meets business and regulatory needs. [1] [2]

Guideline versions

GMPs are enforced in the United States by the U.S. Food and Drug Administration (FDA), under Title 21 CFR. The regulations use the phrase "current good manufacturing practices" (CGMP) to describe these guidelines. [7] [8] [9] [10] Courts may theoretically hold that a product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards. [11] However, since June 2007, a different set of CGMP requirements have applied to all manufacturers of dietary supplements, with additional supporting guidance issued in 2010. [4] Additionally, in the U.S., medical device manufacturers must follow what are called "quality system regulations" which are deliberately harmonized with ISO requirements, not necessarily CGMPs. [9]

The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over 100 countries worldwide, primarily in the developing world. [3] The European Union's GMP (EU-GMP) enforces similar requirements to WHO GMP, as does the FDA's version in the US. Similar GMPs are used in other countries, with Australia, Canada, Japan, Saudi Arabia, Singapore, Philippines, Vietnam and others having highly developed/sophisticated GMP requirements. [12] In the United Kingdom, the Medicines Act (1968) covers most aspects of GMP in what is commonly referred to as "The Orange Guide," which is named so because of the color of its cover; it is officially known as Rules and Guidance for Pharmaceutical Manufacturers and Distributors. [13]

Since the 1999 publication of GMPs for Active Pharmaceutical Ingredients, by the International Conference on Harmonization (ICH), GMPs now apply in those countries and trade groupings that are signatories to ICH (the EU, Japan and the U.S.), and applies in other countries (e.g., Australia, Canada, Singapore) which adopt ICH guidelines for the manufacture and testing of active raw materials. [12]

Enforcement

Within the European Union GMP inspections are performed by National Regulatory Agencies. GMP inspections are performed in Canada by the Health Products and Food Branch Inspectorate; [14] the United Kingdom by the Medicines and Healthcare Products Regulatory Agency (MHRA); [15] in the Republic of Korea (South Korea) by the Ministry of Food and Drug Safety (MFDS); [16] in Australia by the Therapeutic Goods Administration (TGA); [17] in Bangladesh by the Directorate General of Drug Administration (DGDA); [18] ; in South Africa by the Medicines Control Council (MCC); [19] in Brazil by the National Health Surveillance Agency (ANVISA); [20] in India by state Food and Drugs Administrations (FDA), reporting to the Central Drugs Standard Control Organization; [21] in Pakistan by the Drug Regulatory Authority of Pakistan; [22] in Nigeria by NAFDAC; [23] and by similar national organizations worldwide. Each of the inspectorates carries out routine GMP inspections to ensure that drug products are produced safely and correctly. Additionally, many countries perform pre-approval inspections (PAI) for GMP compliance prior to the approval of a new drug for marketing.

CGMP inspections

Regulatory agencies (including the FDA in the U.S. and regulatory agencies in many European nations) are authorized to conduct unannounced inspections, though some are scheduled. [7] [13] [16] [17] [18] [19] [21] [22] [23] FDA routine domestic inspections are usually unannounced, but must be conducted according to 704(a) of the Food, Drug and Cosmetic Act (21 USCS § 374), which requires that they are performed at a "reasonable time". Courts have held that any time the firm is open for business is a reasonable time for an inspection. [24]

Other good practices

Other good-practice systems, along the same lines as GMP, exist:

Collectively, these and other good-practice requirements are referred to as "GxP" requirements, all of which follow similar philosophies. Other examples include good guidance practices, and good tissue practices.

See also

References

  1. 1 2 3 Institute of Food Science & Technology (2012). Food and Drink - Good Manufacturing Practice - A Guide to its responsible management. Wiley-Blackwell. p. 280. ISBN   9781118318232.
  2. 1 2 3 4 5 6 Moore, I. (2009). "Chapter 5: Manufacturing Cosmetic Ingredients According to Good Manufacturing Principles". In Lintner, K. Global Regulatory Issues for the Cosmetic Industry. Elsevier. pp. 79–92. ISBN   9780815519645.
  3. 1 2 Nally, J.D., ed. (2007). Good Manufacturing Practices for Pharmaceuticals (6th ed.). CRC Press. p. 424. ISBN   9781420020939.
  4. 1 2 "Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide". U.S. Food and Drug and Administration. 12 November 2017. Retrieved 2 February 2018.
  5. Ramakrishna, S.; Tian, L.; Wang, C.; et al., eds. (2015). "Chapter 3.: Quality management systems for medical device manufacture". Medical Devices: Regulations, Standards and Practices. Woodhead Publishing Series in Biomaterials. 103. Elsevier. pp. 49–64. ISBN   9780081002919.
  6. World Health Organization (2007). "Chapter 1: WHO good manufacturing practices: Main principles for pharmaceutical products". Quality Assurance of Pharmaceuticals: A compendium of guidelines and related materials - Good manufacturing practices and inspection. 2 (2nd updated ed.). WHO Press. pp. 17–18. ISBN   9789241547086.
  7. 1 2 "Facts About the Current Good Manufacturing Practices (CGMPs)". U.S. Food and Drug Administration. 6 October 2017. Retrieved 2 February 2018.
  8. "Current Good Manufacturing Practices (CGMPs)". U.S. Food and Drug Administration. 27 December 2017. Retrieved 2 February 2018.
  9. 1 2 "Quality System (QS) Regulation/Medical Device Good Manufacturing Practices". U.S. Food and Drug Administration. 2 February 2018. Retrieved 2 February 2018.
  10. "Draft Guidance for Industry: Cosmetic Good Manufacturing Practices". U.S. Food and Drug Administration. 3 November 2017. Retrieved 2 February 2018.
  11. "US CFR Title 21 §210.1(b) Status of current good manufacturing practice regulations". Electronic Code of Federal Regulations. Retrieved 24 August 2017.
  12. 1 2 Cartwright, A.C.; Matthews, B.R., eds. (2010). "Preface". International Pharmaceutical Product Registration (2nd ed.). CRC Press. pp. vi–x. ISBN   9781420081831.
  13. 1 2 Medicines and Healthcare Products Regulatory Agency. "Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017". Pharmaceutical Press. Retrieved 2 February 2018.
  14. "Good Manufacturing Practices". Health Canada. Government of Canada. 27 February 2015. Retrieved 2 February 2018.
  15. Medicines and Healthcare Products Regulatory Agency (20 October 2017). "Good manufacturing practice and good distribution practice". Gov.uk. Retrieved 2 February 2018.
  16. 1 2 Ministry of Food and Drug Safety (April 2017). "Guide to Drug Approval System in Korea" (PDF). National Institute of Food and Drug Safety Evaluation. Retrieved 2 February 2018.
  17. 1 2 "Good manufacturing practice - an overview". Department of Health, Therapeutic Goods Administration. 29 September 2017. Retrieved 2 February 2018.
  18. 1 2 Anisfeld, M.H.; Kim, E.M.; Aimiuwu, J.; Thumm, M. (May 2015). "Assessment of the Good Manufacturing Practices Inspection Program of the Bangladesh Directorate General of Drug Administration". World Health Organization. Retrieved 2 February 2018.
  19. 1 2 Medicines Control Council (August 2010). "Guide to Good Manufacturing Practice for Medicines in South Africa" (PDF). Medicines Control Council. Retrieved 2 February 2018.
  20. World Trade Organization (13 May 2015). "Draft Technical Resolution nº 42, May 13th 2015" (PDF). Retrieved 2 February 2018.
  21. 1 2 "Updated list of WHO GMP Certified Manufacturing Units for Certificate of Pharmaceutical Products (COPP) in various States of India as on December 2016". Central Drugs Standard Control Organization. 10 June 2017. Retrieved 2 February 2018.
  22. 1 2 "S.R.O. 1012(I)/2017" (PDF). The Gazette of Pakistan. Government of Pakistan. 9 October 2017. Retrieved 2 February 2018.
  23. 1 2 "GMP Guidelines". National Agency for Food and Drug Administration and Control. Retrieved 2 February 2018.
  24. U.S. Food and Drug Administration (October 2014). "Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection" (PDF). Retrieved 2 February 2018.