WCG’s Quality Assurance Department is committed to collaborating with manufacturing partners to ensure the delivery of safe, effective products, and ensuring GMP compliance to global regulatory requirements.  Prior to commercial distribution, each manufacturing partner is qualified by the WCG QA team. A GMP assessment is conducted to determine the manufacturer’s state of compliance, which includes verification of current regulatory status and performance of an onsite cGMP audit at the manufacturing facility. Inspection and test results are verified for compliance to product specification for each production lot, and corrective action requests are issued to manufacturers to address any identified nonconformities.  Additionally, distributed products are monitored for post market surveillance issues.

WCG QA currently provides quality operations support to government sponsors and global pharmaceutical and medical devices manufacturing partners, including the United States Agency for International Development (USA – USAID EECO Project); Evofem Biosciences (USA – Non-Hormonal Contraceptive Gel), Shanghai Dahua Medical Apparatus Company (China – Woman’s Condom), Medicines 360 (USA – Levonorgestrel Intra-Uterine System), Kessel MEDintim (Germany – SILCS Diaphragm and Gel), Grünenthal Chilena (Chile – Progesterone Vaginal Ring).