Development and implementation of a quality assurance program for a hormonal contraceptive implant

摘要: Abstract Background The importance of the distribution safe, effective and cost-effective pharmaceutical products in resource-constrained countries is subject increasing attention. FHI 360 has developed a program aimed at evaluating quality contraceptive implant manufactured China, while product being registered an number distributed by international procurement agencies. consists (1) independent testing; (2) ongoing evaluation manufacturing facility through audits inspections; (3) post-marketing surveillance. Study Design This article focuses on laboratory testing product. various test methods were chosen from following method compendia, United States Pharmacopeia (USP), British (BP), International Organization for Standardization (ISO), American Society Testing Materials (ASTM), or lot release tests mandated Chinese regulatory requirements. Each independently tested prior to its supported this program. In addition, more detailed annual includes active ingredient (levonorgestrel), final packaging material. Results Over first 4 years 5-year project, all lots met established criteria. Conclusions assurance helped ensure that safe was introduced into developing country family planning programs. provides template establishing programs other have not yet received stringent approval are resource-poor settings.