EXCiPACT Certification
EXCiPACT certification offers an efficient and cost-effective solution for the pharmaceutical excipients industry to demonstrate that its quality management systems meet internationally recognized high standards. This is crucial for ensuring the final quality of pharmaceuticals and patient safety.
Introduction to EXCiPACT Certification
EXCiPACT certification is an international standard designed specifically for manufacturers, suppliers, and distributors in the pharmaceutical excipients supply chain. This certification aims to ensure that companies involved in the production and supply of pharmaceutical excipients adhere to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), ensuring the quality and safety of these excipients. Developed by experts in the excipients industry, the EXCiPACT standard is intended to reduce the need for pharmaceutical manufacturers to conduct multiple audits of excipient suppliers while providing a unified quality assurance benchmark.
Advantages of EXCiPACT Certification
1. Ensures the quality and safety of pharmaceutical excipients throughout the production and supply process by implementing GMP and GDP principles.
2. Provides pharmaceutical manufacturers with a reliable third-party certification system, reducing the need for repeated audits of excipient suppliers, saving time and resources.
3. Offers excipient suppliers an internationally recognized quality assurance standard, enhancing their global competitiveness.
How to Obtain Certification
Kaixin Certification can provides an accredited certification against the EXCiPACT standard. Clients and customers willing to undergo certification needs to complete the application and contract agreement process following which initial or re-certification audits will be carried out. Once the certificate is issued (with a 3 year validity), further surveillance audits will have to be carried out at pre-defined frequencies to maintain the validity of the certificate.