BCK Passes 2026 EXCiPACT International Audit
On March 3, 2026, Beijing Cotecna Kaixin Certification Co., Ltd. (hereinafter referred to as "BCK") successfully passed the annual audit by the EXCiPACT Office, marking that the company's professional capabilities and compliance standards in providing GMP/GDP certification services for pharmaceutical excipients have once again been internationally recognized. This audit was fully hosted by Mr. Bi, the Quality Manager of EXCiPACT China and a seasoned expert, and the review scope covered core dimensions such as the standardization of the certification process, the management of auditor capabilities, and the operation of the quality system.
During the review period, Mr. Bi, with over three decades of experience in quality management in the pharmaceutical industry and a background in multinational pharma sector, conducted a detailed review of BCK's review process, document management, technical support, etc. He particularly affirmed the company's outstanding performance in quality record storage and the continuous improvement of auditor capabilities, believing that it fully complies with EXCiPACT's quality system requirements and auditor capability regulations for certification bodies. The company has been simultaneously recognized by the China National Accreditation Service for Conformity Assessment (CNAS) and the American National Accreditation Board (ANAB). This successful passage of the EXCiPACT annual audit further validates BCK's international standard and credibility of its certification services.
EXCiPACT is a non-profit international organization that was established in Belgium in 2014. Its GMP/GDP certification scheme for pharmaceutical excipients is globally recognized as an authoritative standard by regulatory bodies in the EU, the US, and many other countries. The core value of this sheme lies in minimizing risks and maximizing trust through independent third-party certification. It not only reduces the cost of repetitive audits for excipient suppliers but also provides reliable grounds for pharmaceutical companies to select qualified suppliers. The certification system strictly adheres to the requirements of the relevant appendices of ISO 9001, imposing extremely strict regulations on the quality system of certification bodies and the professional capabilities of auditors. Obtaining the review means that the institution is qualified to provide international compliance certification services for the production, supply, and distribution of pharmaceutical excipients.
In the future, BCK will continue to leverage the EXCiPACT international standard standards framework, focus on the quality improvement needs of the pharmaceutical excipient industry, provide customers with more targeted certification services and technical support, help upstream and downstream of the industrial chain to reduce compliance costs and optimize supply chain security, and ultimately contribute to ensuring the quality of drugs and the safety of patients.
About Cotecna Kaixin Certification
Beijing Cotecna Kaixin Certification Co., Ltd. is a third-party certification body accredited by CNAS and ANAB. Focusing on providing certification services covering quality and safety, agri-food products, intellectual property, information security, energy, and sustainability, we have served over 20,000 clients, and remains committed to delivering premium and efficient service to clients, contributing to economic prosperity, environmental sustainability, and social responsibility.