Overview of the Current GxP Requirements (bold: widely accepted as reference standard); Note: please check for applicable regional/domestic requirements
| Requirement Issued By | Research | GLP | GCP | GPvP | GMP for API | GMP for Excipients | GMP for Drug Product | GDP |
|---|---|---|---|---|---|---|---|---|
| ICH | - none - | ICH M3(R2): “Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals” ICH S6: “Preclinical Safety Evaluation of Biotechnology–derived Pharmaceuticals” | ICH E6: “Good Clinical Practice” and related ICH efficacy topics | ICH E2E: “Pharmacovigilance Planning” | ICH Q7: “GMP for API” | - none - | For biological products see: ICH Q5 series: Quality of Biotechnological Products | - none - |
| US | - none - | 21CFR Part 58: Good Laboratory Practices for Non Clinical Laboratory Studies | 21CFR 50 and 21 CFR 56 http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm155713.htm FDA guidance on assessing clinical trials is found at: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/default.htm | Adopted ICH guideline—21 CFR 314.80 | see ICH Q7 guideline | - none - | 21 CFR Part 210 and 211 21 CFR Part 11 (CSV) 21 CFR 600 (Biological products) | U.S. Code of Federal Regulations Title 21 Parts 11, 210, 211 and 820 U.S. Code of Federal Regulations Title 49 - USP: Good Storage and Shipping Practices (USP 28, NF 23, Chapter 1079, 2005) |
| EU | - none - | DIRECTIVE 2004/10/EC: Application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) DIRECTIVE 2004/9/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) | Annex IV GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Sponsor and CRO Version: 28 May 2008: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol10_en.htm A Practical handbook for Clinical Audit, Clinical Governance Support Team, NHS, 2005 (UK) | Adopted ICH guideline Requirements for the Qualified Person for Pharmacovigilance (QPPV): Directive 2001/83/EC (as amended) and regulation 726/2004 | EUDRALEX Vol. 4: Good Manufacturing practice: Part II (API; including ICH Q7) | - non; however requested by the falsified medicines directive | EUDRALEX Vol. 1 (legislation): EU Council Directive 2001/83/EC, Medicinal Products Directive and 2001/20/EC (IMPs) EUDRALEX Vol. 4: Good Manufacturing practice: Part I and II: Chapters (medicinal products); Annexes (regarding specific product categories or additional regulations (e.g., process validation))* GMP for Medical Devices/Combination products: EU Council Directive 93/42/EEC, Medical Devices Directive. The amendment is 2007/47/EC and was implemented as of March 2010. | EEC: Guidelines on Good Distribution Practice of Medicinal Products for Human Use (No: 94/C 63/03); April 4th, 1992; currently under revision |
| Japan | - none - | Ministry of Health and Welfare Ordinance No.21 of March 26, 1997 | Pharmaceutical Administration and Regulations in Japan, 2008.3, Good Clinical Practice. See also http://www.jpma.or.jp/english/and the JSQA Guideline for GCP Auditing, 2007, Japan Society for Quality Assurance | - Adopted ICH guideline - | see ICH Q7 guideline | - none - | Good Manufacturing Practice (GMP): Ordinance: No 179 Good Quality Practice (GQP): Ordinance: No 136 (incl. Batch Release and PQS requirements) GMP for Medical Devices/Combination products: 21 CFR 820, Quality System Regulation 21 CFR Part 4, Current Good Manufacturing Practice Requirements for Combination Products, Proposed Rule, September 23, 2009 | None—WHO guidelines as reference |
| WHO | - none - | UNDP/World Bank/WHO: Special Program for Research and Training in Tropical Diseases (TDR) HANDBOOK GOOD LABORATORY PRACTICE (GLP) | WHO Library Cataloguing-in-Publication Data Handbook for good clinical research practice (GCP) Guidance for implementation (WHO 2002) Guidelines for good clinical practice (GCP) for trials on pharmaceutical products (1995) | WHO Technical Report Series, No. 850, 1995, Annex 3 | WHO Technical Report Series 957, Annex 2, 2010 GMP for Active Pharmaceutical Ingredients | WHO Technical Report Series 885, Annex 5, 1999: “GMP: supplementary guidelines for the manufacturer of pharmaceutical excipients” | Good manufacturing practices and inspection, Volume 2 of Quality assurance of Pharmaceuticals, A compendium of guidelines and related materials Other best practices are available e.g. “Recommendations for the evaluation of animal cell cultures.” | Good distribution practices for pharmaceutical products, WHO Technical Report Series, No. 957: Annex 5, 2010 Guide to good storage practices for pharmaceuticals, WHO Technical Report Series, No. 908, Annex 9—Good trade and distribution practices for pharmaceutical starting materials, WHO Technical Report Series, No. 917, Annex 2 |
| Others | While there is no specific regulatory requirement, companies should apply sound scientific principles, including appropriate documentation and record keeping in order to form the basis for a development report | Organisation for Economic Co-operation and Development (OECD) principles on chemical safety and biosafety: (http://www.oecd.org; specific: Good Laboratory Practice (GLP) http://www.oecd.org/document/1/0,3746,en_2649_37465_48477249_1_1_1_37465,00.html) including the Mutual Acceptance of Data (MAD) in the Assessment of Chemicals | The engaged Auditing Guideline for GCP Compliance and Quality Management Systems Auditing, by the European Forum for GCP Audit Working Party: http://www.efgcp.be/Downloads/Revised%20ENGAGE%20Auditing%20Guideline.pdf | - none - | - none - | IPEC: Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients | In addition GMPs for biological starting materials and raw materials such as bovine serum, cell banks, viral seeds need to be considerd | GDP for Excipients: IPEC: Good Distribution Practices Audit Guideline UN Recommendations on the Transport of Dangerous Goods e.g. International Carriage of Dangerous Goods by Road (ADR); International Carriage of Dangerous Goods by Inland Waterways (ADN) IATA Perishable Cargo Regulations—Chapter 17 IATA Dangerous Goods Regulations (52nd edition) Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment (revised 2007), PDA Technical Report No 39 - Guidance for Good Distribution Practices for 368 Pharmaceutical Products to the End User PDA Technical Report No 46, 2009. |
↵* Note: Also implemented by PIC/S as GMP excluding Annex 16 on release of products (QP requirements).