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APPENDIX C

BIBLIOGRAPHY

Bulk Pharmaceutical Chemicals (BPCs), Drug Quality Assurance, Chapter 56, Program 7356.002F, FDA Compliance Program Guidance Manual, October 2000.

Code of Federal Regulations Title 21 Food and Drugs Parts 210 and 211, US Food and Drug Administration (FDA), Washington DC, USA.

Codex Alimentarius – Food Hygiene – Basic Texts – Second Edition, Food Hygiene, Food and Agriculture Organization of the United Nations and World Health Organization, Rome, 2001.

European Commission, Committee for Proprietary Medicinal Products, CPMP/QWP/1529/04 Guideline on control of Impurities of Pharmacopoeial Substances, April 2004.

Rules and Guidance for Pharmaceutical Manufacturers and Distributors, Medicines and Healthcare products Regulatory Agency, 2002.

UK Guidance on Certificates of Analysis in Rules and Guidance for Pharmaceutical Manufacturers and Distributors, Medicines and Healthcare products Regulatory Agency, 2002, page 32.

European Commission, Committee for Proprietary Medicinal Products, The Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practices.

European Commission Guideline on Dossier Notification Requirements for Part 1A, March 2005 and Part 1B, July 2003.

European Union, Commission Directive, 2004/27/EC, amending Directive 2001/83/EC on the community code relating to medical products for human use.

European Union, The Rules Governing Medicinal Products in the European Union, Notice to Applicants, Volume 2B CTD (June 2004).

European Union, Council Directive, 93/43/EEC, on the hygiene of foodstuffs.

Guide to Inspection of Bulk Pharmaceutical Chemicals, (Reference Materials and Training Aids for Investigators), Food and Drug Administration, Div. of Field Investigations (IBC-130), Division of Manufacturing and Product Quality (HFD-320), Rev. Sept. 1991.

Hazard Analysis and Critical Control Point Principles and Application Guidelines, FDA - August 1997.

International Conference on Harmonization (ICH), Stability Testing and Data, Q1 series, 1996 – 2003.

International Conference on Harmonization (ICH), Validation of Analytical Methods, Q2 series, 1994 – 1998.

International Conference on Harmonization (ICH), Note for Guidance on Impurities: Residual Solvents Q3C, 1997.

International Conference on Harmonization (ICH), Note for Guidance on Good Manufacturing Practices for Active Pharmaceutical Ingredients Q7A, 2001.

International Conference on Harmonization (ICH), Quality Risk Management Q9 (Consultation), 2005.

Copyright © 2006 The International Pharmaceutical Excipients Council and Copyright © 2006 Pharmaceutical Quality Group

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