Document Detail


Development and implementation of a quality assurance program for a hormonal contraceptive implant.
MedLine Citation:
PMID:  22921687     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BACKGROUND: The importance of the distribution of safe, effective and cost-effective pharmaceutical products in resource-constrained countries is the subject of increasing attention. FHI 360 has developed a program aimed at evaluating the quality of a contraceptive implant manufactured in China, while the product is being registered in an increasing number of countries and distributed by international procurement agencies. The program consists of (1) independent product testing; (2) ongoing evaluation of the manufacturing facility through audits and inspections; and (3) post-marketing surveillance. STUDY DESIGN: This article focuses on the laboratory testing of the product. The various test methods were chosen from the following test method compendia, the United States Pharmacopeia (USP), British Pharmacopeia (BP), International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), or lot release tests mandated by Chinese regulatory requirements. Each manufactured lot is independently tested prior to its distribution to countries supported by this program. In addition, a more detailed annual testing program includes evaluation of the active ingredient (levonorgestrel), the final product and the packaging material. RESULTS: Over the first 4 years of this 5-year project, all tested lots met the established quality criteria. CONCLUSIONS: The quality assurance program developed for this contraceptive implant has helped ensure that a safe product was being introduced into developing country family planning programs. This program provides a template for establishing quality assurance programs for other cost-effective pharmaceutical products that have not yet received stringent regulatory approval and are being distributed in resource-poor settings.
Authors:
Derek H Owen; David Jenkins; Aida Cancel; Eli Carter; Laneta Dorflinger; Jeff Spieler; Markus J Steiner
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-8-23
Journal Detail:
Title:  Contraception     Volume:  -     ISSN:  1879-0518     ISO Abbreviation:  Contraception     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2012-8-27     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0234361     Medline TA:  Contraception     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 Elsevier Inc. All rights reserved.
Affiliation:
FHI 360, P.O. Box 13950, Research Triangle Park, NC 27709, USA.
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