title: Development and implementation of a quality assurance program for a hormonal contraceptive implant.
abstract: 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.
  
  
  METHODS
  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.affiliation: FHI 360, Research Triangle Park, NC 27709, USA. dowen@fhi360.org
authors.forename: Derek H
authors.initials: DH
authors.lastname: Owen
authors.forename: David
authors.initials: D
authors.lastname: Jenkins
authors.forename: Aida
authors.initials: A
authors.lastname: Cancel
authors.forename: Eli
authors.initials: E
authors.lastname: Carter
authors.forename: Laneta
authors.initials: L
authors.lastname: Dorflinger
authors.forename: Jeff
authors.initials: J
authors.lastname: Spieler
authors.forename: Markus J
authors.initials: MJ
authors.lastname: Steiner
mesh_terms: D002681:China; D003271:Contraceptive Agents, Female / Q000008:administration & dosage / Q000592:standards*; D016912:Levonorgestrel / Q000008:administration & dosage / Q000592:standards*; D011358:Product Surveillance, Postmarketing; D011785:Quality Assurance, Health Care / Q000379:methods*; D006113:United Kingdom; D014481:United States
chemical_list: D003271:Contraceptive Agents, Female; D016912:Levonorgestrel