Procedures for complaints and recalls for manufacturers
Article 65
1. A system shall be put in place to ensure that all quality-related complaints, whether received orally or in writing, are recorded and thoroughly investigated and that appropriate actions are implemented, including the recall of the active substance where appropriate. Operating procedures shall be developed describing the actions to be taken upon the receipt of a quality-related complaint. 2. Complaint records shall include the following: (a) name or company name and permanent address or registered place of business of complainant; (b) name, title, where appropriate, and contact details of the person submitting the complaint; (c) nature of the complaint, including name and batch number of the active substance; (d) date the complaint is received; (e) action initially taken, including dates and identity of person taking that action; (f) any follow-up action taken; (g) response provided to the originator of the complaint, including the date of the response; (h) final decision on the intermediate or active substance batch concerned. 3. When a quality defect is discovered or suspected in a batch, consideration shall be given whether it is necessary to check other batches or, as appropriate, other products to determine if they are also affected. Batches that may contain portions of the defective batch or components shall be investigated. 4. The priority during an investigation shall be to ensure that appropriate risk-minimisation measures are taken. All decisions and measures adopted shall reflect the level of risk and shall be documented. The effectiveness of the corrective and preventive measures implemented shall be monitored. 5. Procedures for the recall of active substances shall be established, which shall include how a recall is to be initiated, who is to be informed in the event of a recall (including relevant authorities) and how the recalled material is to be treated.