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Quality Agreement Api Supplier

03 Oct

The International Pharmaceutical Excipient Council (IPEC) saw this challenge as an opportunity to improve communication between users and suppliers of adjuvants and developed the IPEC Quality Agreement Template in June 2009. The guide and presentation were the result of several years of work by the IPEC Quality Agreement Souscommittee, composed of excipient manufacturers, distributors and users of IPEC-Americas and IPEC-Europe. IPEC is an international trade association composed of members of the pharmaceutical and ancillary products industry. One of the objectives of IPEC is to develop and implement voluntary sectoral guidelines that improve the quality of auxiliaries used in pharmaceutical products. IPEC sees the quality agreement as an instrument that creates a quality partnership between two companies. The parties to the drafting of the agreement must therefore be flexible. The objective of the IPEC Quality Agreement is to provide users and suppliers of auxiliaries with a common starting point for establishing their own quality agreements, which address basic quality issues specific to the production and use of auxiliaries. Recent regulatory requirements and several supply chain violations for pharmaceutical substances (APIs) and auxiliaries have increased the pharmaceutical industry`s awareness of supply chain monitoring and control and the need to improve it. One result has been the increasing use of quality agreements between drug ingredient manufacturers (including manufacturers), suppliers and distributors. .

 
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