Quality assurance

We are committed to ensuring the quality, safety and effectiveness of our products.

In operation since 2004, our current manufacturing facility was designed and built to meet Good Manufacturing Practice (GMP) standards. Our facility received its GMP certification from the China Food and Drug Administration (CFDA) in 2004, and our certification has been continuously renewed since then through re-inspections in 2009 and 2013. Our facility was also deemed to be in compliance with World Health Organization (WHO) GMP first in 2013 and then again in 2015, following re-inspection.

We are also ISO 9001 and ISO13485 certified.

We implement a continuous evaluation process to ensure the quality of our products through lot-release testing prior to distribution. Based on methods approved by the CFDA for levonorgestrel silicone elastomer implants, these tests include identification, assay and dissolution of the active ingredient testing as well as product sterility testing.

In addition, since 2008, independent annual quality evaluations have been conducted by FHI 360, a leading international development organization based in the U.S. with over 20 years of experience testing the quality of public health products. This annual assessment has included independent lot-release testing as well as an extensive battery of tests on the active ingredients, final products, sterilization and packaging. FHI 360's testing uses standards from the United States Pharmacopeia (USP), European Pharmacopoeia (EP), the British Pharmacopoeia (BP), the International Organization for Standardization (ISO), and the ASTM (formerly the American Society for Testing and Materials). The findings have consistently shown Dahua's competency to produce contraceptive implants that meet international quality standards.

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