Drug Substance Starting Material Selection - Pharmaceutical Technology

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Drug Substance Starting Material Selection
The authors review the current regulatory framework for the selection of drug substance starting materials.

Pharmaceutical Technology
Volume 32, Issue 12, pp. 52-57


1. R.J. Timko et al., "Drug Substance Starting Materials: A Regulatory Perspective on Requirements and Selection," poster presented at American Association of Pharmaceutical Scientists Annual Meeting, Nashville, TN, Nov. 2005.

2. ICH Q8 Pharmaceutical Development (Geneva, Switzerland, May 2006).

3. ICH Q9 Quality Risk Management (Geneva, Switzerland, June, 2006).

4. FDA, Guidance for Industry: BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation, Feb. 2001, withdrawn, Fed. Regist. Notice June 1, 2006.

5. FDA, Guidance for Industry: Drug Substance: Chemistry, Manufacturing, and Controls Information, Jan. 2004, withdrawn Fed. Regist. Notice June 1, 2006.

6. ICH Q7 Good Manufacturing Guide For Active Pharmaceutical Ingredients, (Geneva, Switzerland, Aug. 2001).

7. FDA, Guidance for Industry: Guidance for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances (Rockville, MD, Feb. 1987).

8. FDA, Guidance for Industry: Changes to an Approved NDA or ANDA, Rev. 1 (Rockville, MD, Apr. 2004).

9. EMEA Committee for Proprietary Medicinal Products, Guidance on the Chemistry of New Active Substances, CPMP/QWP/130/96, Rev 1 (London, England, Dec. 17, 2003).

10. EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Part II, Basic Requirements for Active Substances used as Starting Materials (Brussels, Belgium, Oct. 2005).

11. EDQM Division Certification of Substances, Public Document PA/PH/Exp. CEP/T (06) 35, "Certification of Suitability of Monographs of the European Pharmacopoeia. How Can the Content of the Applications for a Certificate of Suitability for Chemical Purity Be Improved? The Top 10 Deficiencies found in applications" (Strasbourg, France, Dec. 2006).

12. MHLW, Pharmaceutical and Food Safety Bureau, Guidelines on Mentions in Manufacturing / Marketing Approval Application Dossiers for Pharmaceuticals and Others Based on Revised Pharmaceutical Affairs Law, PFSB/ELD 020001 (Tokyo, Japan, Feb. 10, 2005).

13. FDA, Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach, Final Report (Rockville, MD, Sept. 2004).

14. ICH Q3A R2 Impurities in New Drug Substances (Geneva, Switzerland, June 2006).

15. ICH Q3C Impurities: Residual Solvents (Geneva, Switzerland, Dec. 1997, and ICH Q3C Tables and Lists, Rev. 3, Nov. 2005).

16. ICH Q6A Specifications: Test Procedures and Acceptance Criteria For New Drug Substances and New Drug Products: Chemical Substances (Geneva, Switzerland, Oct. 1999).

17. L. Muller et al., "A Rationale for Determining, Testing, and Controlling Specific Impurities in Pharmaceuticals That Possess Genotoxicity," Regulatory Toxicology & Pharmacology 44, 198–211 (2006).

18. EMEA Committee for Medicinal Products for Human Use, Guideline on the Limits of Genotoxic Impurities, CPMP/SWP/5199 (London, England, June 28, 2006).

19. Code of Federal Regulations, Title 21, Food and Drugs, Volume 3, Chapter 1, Subpart B: Food Additive Safety, Section 170.39: Threshold of Regulation for Substances Used in Food-Contact Articles (General Services Administration, Revised Apr. 1, 2007).

20. D. Jacobson-Kram and T. McGovern, 'Toxicological Overview of Impurities in Pharmaceutical Products," Advanced Drug Delivery Reviews 59 (1), 38–42, 2007.


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