GMP is the abbreviation of Good Manufacturing Practices. The term “Good Manufacturing Practices” is a popular term in the pharmaceutical industry. The company needs to be certified according to the GMP in order to produce and sell the products to the market.
GMP is the guidelines that are laid out by the agencies for the authorization and control of manufacturing of products such as pharmaceutical products, medical devices, active pharmaceutical ingredients, etc. Adhering to GMP guidelines assure the agencies about the quality of the products and that the manufacturers’ practices have met the guideline to ensure the safety of the product.
The fundamental standard for ensuring the quality of human pharmaceuticals is the cGMPs regulation according to FDA guidelines. Adherence to the cGMP requirements assures the identity, strength, high quality, and purity of drugs by requiring that manufacturers of products adequately inspect manufacturing processes. This comprises establishing consistent quality management systems, obtaining appropriate quality of raw materials, robust procedures of management and manufacturing processes and, detecting and investigating product deviations, and maintaining reliable testing laboratories. It’s a formal system of controls at a pharmaceutical company if it is adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. In this way, the implemented system assures that drug products meet their quality standards.
cGMP consists of a great number of practices that focus on several phases of manufacturing as well as Quality. However, they’re just minimum requirements that companies have already implemented in their quality and risk management systems.
On the other hand, The European Medicines Agency (EMA) lays down these regulations for the pharmaceutical manufacturers in their manufacturing processes. EMA coordinates inspections to make sure compliance with regulations and performs a key role in harmonising GMP activities at European Union (EU) level.
Any manufacturer who intends to sell their products in the EU market, no matter the company is located, must comply with Good manufacturing practice (GMP).
GMP requires that drugs:
are of consistent high quality;
are appropriate for their intended use;
meet the requirements of the marketing authorisation or clinical trial authorisation.
Good manufacturing practices are supervised by regulatory agencies in the United States, Canada, Europe, China, and other countries.
The most common guidelines for GMP are:
Part 314 For FDA approval to market a new drug.
Part 210. Current Good Manufacturing Practice in Manufacturing Processing, Packing, or Holding of Drugs.
Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals.
Part 212. Current Good Manufacturing Practice for Positron Emission Tomography Drugs.
Part 600. Biological Products: General.
WHO Good Manufacturing Practices for pharmaceutical products,
Pharmaceutical Inspection Co-operation Scheme (PICs)
References for relevant standards and GMP guides/codes
(1) EU Annex 11 to the EU guidelines of Good Manufacturing Practice for Medicinal Products.
(2) Annex 11 to PIC/S Guide to Good Manufacturing Practice for Medicinal Products, Document PH 1/97 (Rev. 3), PIC/S Secretariat, 9-11 rue de Varembé, CH-1211 Geneva 20
(3) GAMP Guide for Validation of Automated Systems, GAMP4 (ISPE (GAMP Forum), 2001)
(4) Australian Code of GMP for Medicinal Products, August 2002.
(5) WHO Guideline for GMP for Manufacture of Pharmaceutical Products.
(6) Relevant CFR sections of the US FDA Register: Hardware
- 21 CFR 211.63, 67, 68
- 21 CFR Part 11 Electronic Records: Electronic Signatures Software
- 21 CFR 211.68, 180, 188, 192
- 21 CFR Part11 Electronic Records: Electronic Signatures Quality System
- 21 CFR 820 Quality system regulation - GLP
- 21 CFR 58 Good laboratory practice for non-clinical laboratory studies
(7) ISO standards: Quality management and quality assurance
- ISO 9000-1 Part 1: Guidelines for selection and use.
- ISO 9000-3 Part 3: Guidelines for the application of ISO9001:1994 to the development, supply, installation and maintenance of computer software.
- See also current Tick-IT Guide for construction, software engineering, assessment and certification (see ref. 12 re:BSI DISC London)
Quality Management and quality system elements
- ISO 9004-1 Part 1: Guidelines.
- ISO 9004-2 Part 2: Guidelines for Services .
- ISO 9004-4 Part 4: Guidelines for quality improvement.
- ISO 10005: 1995 Quality management - Guidelines for quality plans.
- ISO 10007: 1995 Quality management - Guidelines for Configuration Management Life cycle management
- ISO/IEC 12207:1995 Information Technology - Software Life Cycle processes
- ISO/IEC 17799:2000 (BS 7799-1:2000) Information technology – Code of practice for information security management.
(8) IEEE Publications:
- IEEE 729 Glossary of Software Engineering Terminology
- IEEE 730 Quality Assurance Plan
- IEEE 828 Software Configuration Management Plans
- IEEE 829 Software Test Documentation
- IEEE 830 Guide to Software Requirements Specification
- IEEE 983 Guide to Software Quality Assurance Planning
- IEEE 1012 Software Verification Plans
- IEEE 1298 Software Quality Management System Part 1: Requirements
(9) British Standards:
BS 7799: 1999 “Information Security Management”, BSI DISC 389
BS 7799: 2000 Information technology – Code of practice for information management
(10) DISC BSI Guides
- DISC PD 5000 series of ‘Codes for Electronic Documents and e-Commerce Transactions as Legally Admissible Evidence’ (including DISC PD 0008:1999 in Pt 1):
- Pt 1 Information Stored Electronically
- Pt 2 Electronic Communication and e-mail policy
- Pt 3 Identity Signature and Copyright
- Pt 4 Using Certification Authorities
- Pt 5 Using trusted Third Party Archives
- DISC PD 3002 Guide to BS 7799 Risk Assessment and Risk Management (ISBN 0 580 29551 6)
- DISC PD 3005 Guide on the selection of BS 7799 controls (ISBN 0 580 33011 7)
(11) ‘Guidance for Industry, Part 11, Electronic Records; Electronic Signatures – Scope and Application’, US Dept. of Health and Human Services and all FDA Centers/ Offices, February 2003. (\\CDS029\CDERGUID\5505dft.doc) – draft guidance for comment.