The IPEC-Americas: Excipient master file guide

Pharmaceutical Technology North America

Volumn 26, Issue 6, 2002, Pages 36-44

  DeMerlis, Christopher C ^a  

^a Div Berwind Pharmaceut Serv Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DATABASE SYSTEMS; ELECTRONIC COMMERCE; INTERNATIONAL COOPERATION;

MASTER FILES;

DRUG PRODUCTS;

DRUG ADDITIVE; EXCIPIENT; NEW DRUG;

ARTICLE; COLOR; DRUG ANALYSIS; DRUG CONTROL; DRUG INFORMATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG QUALITY; DRUG SAFETY; FLAVOR; ORGANIZATION; PRACTICE GUIDELINE; QUALITY CONTROL; RISK ASSESSMENT; UNITED STATES;

EID: 0036627963     PISSN: 15342131     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (11)

1. Harmonized Tripartate Guideline: The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Safety. Nonclincial Summaries and Organization of Module 4 (International Conference on Harmonization, Geneva, Switzerland, 2000).
2. Center for Drug Evaluation and Research, Guidance for Industry: M4Q CTD - Quality (FDA, Rockville, MD, August 2001).
3. The International Pharmaceutical Excipients Council's Significant Change Guide for Bulk Pharmaceutical Excipients (IPEC-Americas, Arlington, VA, 2000).
4. IPEC-America's Guide for the Development of an Impurity Profile (IPEC-Americas, Arlington, VA; 2001).
5. IPEC-America's Certificate of Analysis Guide for Bulk Pharmaceutical Excipients (IPEC-Americas, Arlington, VA, 2000).
6. M. Steinberg et al., "A New Approach to the Safety Assessment of Pharmaceutical Excipients," Regul. Toxicol. Pharmacol. 24 (2), 149-154 (1996).
7. "General Chapter (1074) Excipient Biological Safety Evaluation Guidelines," in USP 24-NF 19 (United States Pharmacopeial Convention, Rockville, MD, 2000), pp. 2037-2040.
8. IPEC Europe Safety Committee, "The Proposed Guidelines for the Safety Evaluation of New Excipients," Eur. Pharm. Review 13-20 November (1997).
9. ICH, Harmonized Tripartate Guideline. Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (International Conference on Harmonization, Geneva, Switzerland, 1997).
10. D.J. George and A.M. Shipp, "Exposure Assessment," in Excipient Toxicity and Safety, M. Weiner and L. Kotkoskie, Eds. (Marcel Dekker, New York, NY, 2000), pp. 283-303.
11. ICH, Harmonized Tripartate Guideline. Impurities: Guideline for Residual Solvent (International Conference on Harmonization, Geneva, Switzerland, 1997).