On April 30, 2020, the International Pharmaceutical Excipients Council (IPEC) Federation published a position paper on the relevance of data integrity guidance documents to the manufacture and supply of excipients.
“Although data integrity is clearly relevant to excipient manufacturing and distribution, excipient suppliers may implement different data integrity controls than DP manufacturers. Data integrity should be applied to excipient manufacturing processes, distribution or other activities where the loss of data integrity would jeopardize compliance with excipient GMPs/GDPs, impact confidence in excipient quality, pose potential harm to the patient, or cause the failure or rejection of the DP. Excipient suppliers should identify risks to their critical data and establish and document controls to implement mitigating measures wherever feasible and appropriate.”
The paper provides recommendations for excipient suppliers, users, and standards.
Download the guidance here.