distribution records authentic certificate of analysis, including those of the original manufacturer expiry/retest date 17.3 Quality Management 17.30 Has the established a system of managing quality as defined in section 2? 17.4 Repackaging, Relabeling and Holding of APIs and IM 17.40 How does the Agent ensure that during repackaging, relabeling and holding of APIs/IM no mix-ups and loss of identity and purity of the API/IM occurs? Are these operations conducted under conditions described in Q7? 17.41 Is repackaging done under conditions to avoid contamination? 17.5 Stability 17.50 Are stability studies conducted if the API is repacked in a different type of container? 17.6 Transfer of Documentation 17.60 Does the Agent transfer all quality and regulatory information from the original manufacturer to the customer? 17.61 Does the agent provide the name of the original manufacturer and the batch number to the customer? 17.63 Is the specific guidance for Certificates of Analysis described in section 11.4 followed? 17.7 Handling of Complaints and Recalls
distribution records authentic certificate of analysis, including those of the original manufacturer expiry/retest date 17.3 Quality Management 17.30 Has the established a system of managing quality as defined in section 2? 17.4 Repackaging, Relabeling and Holding of APIs and IM 17.40 How does the Agent ensure that during repackaging, relabeling and holding of APIs/IM no mix-ups and loss of identity and purity of the API/IM occurs? Are these operations conducted under conditions described in Q7? 17.41 Is repackaging done under conditions to avoid contamination? 17.5 Stability 17.50 Are stability studies conducted if the API is repacked in a different type of container? 17.6 Transfer of Documentation 17.60 Does the Agent transfer all quality and regulatory information from the original manufacturer to the customer? 17.61 Does the agent provide the name of the original manufacturer and the batch number to the customer? 17.63 Is the specific guidance for Certificates of Analysis described in section 11.4 followed? 17.7 Handling of Complaints and Recalls
Auditing_Annex2_AideMemoire.docx