The International Pharmaceutical Excipients Council Federation (IPEC) has published a position paper urging pharma stakeholders to create strategies that ensure the quality of critical data for excipients. Though data integrity is an essential part of any GMP application, much of the regulatory guidance currently available does not outline data integrity requirements for inactive drug products.
IPEC suggested several ways excipient suppliers could improve their data integrity, including the ensured maintenance of product life cycles and the use of training and internal auditing to guarantee compliance with documented data integrity controls. Excipient users were also advised to “manage expectations appropriately when auditing excipient suppliers” as their data integrity controls may differ depending on the type of products developed.
The paper is available at https://bit.ly/2A2QYOJ
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