The Role of the Qualified Person in European Pharmaceutical Regulations - Pharmaceutical Technology

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The Role of the Qualified Person in European Pharmaceutical Regulations
The authors provide a brief overview of the European pharmaceutical regulation with regard to batch certification by a qualified person and batch release for the European market.

Pharmaceutical Technology
Volume 10, Issue 34


1. FDA, "Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach," Final Report, (Rockville, MD, September 2004).

2. Code of Federal Regulations, Title 21, Food and Drugs, (Government Printing Office, Washington, DC), Part 210 and Part 211.

3. European Commission, EudraLex, Volume 4: EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use (Brussels, Feb. 2008).

4. European Commission, Commission Directive 2001/83/EC, "Community Code Relating to Medicinal Products for Human Use," (Brussels, Dec. 2008).

5. European Commission, Commission Directive 2001/82/EC, "Community Code Relating to Veterinary Medicinal Products," (Brussels, Nov. 2004).

6. European Commission, Commission Directive 2001/20/EC, "The Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use," (Brussels, May 2001).

7. European Commission, Commission Directive 2005/28/EC, "Laying Down Principles and Detailed Guidelines for Good Clinical Practice as Regards Investigational Medicinal Products for Human Use, as well as the Requirements for Authorisation of the Manufacturing or Importation of Such Products," (Brussels, Apr. 2005).

8. European Commission, Annex 16 to the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use: "Certification by a Qualified person and Batch Release," (Brussels, July 2001).

9. European Medicines Agency, Reflection Paper on a Proposed Solution for Dealing with Minor Deviations from the Detail Described in the Marketing Authorisation for Human and Veterinary Medicinal Products, Rev1, (London, Jan. 2009).

10. European Commission, Council Directive 75/318/EEC, "The Approximation of the Laws of Member States Relating to Analytical, Pharmaco-Toxicological and Clinical Standards and Protocols in Respect of the Testing of Proprietary Medicinal Products," (Brussels, May 1975).

11. Qualified Person Association, "Good Practice Guide No 2: Duties and Responsibilities for Qualified Persons in the EU," (Heidelberg, Germany, 2009).


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