Records
Article 22
1. Adequate records shall be kept to enable the entire history of a batch to be traced. As a minimum, the following shall be documented: (a) receipt records for each delivery of materials used in the manufacture of the veterinary medicinal products including bulk products, intermediate products, and packaging materials. The receipt records shall include: — the name of the material on the delivery note and the containers as well as any in-house name or internal code, if appropriate; — the name of the supplier and manufacturer; — the supplier’s batch or reference number; — the total quantity and number of containers received; — the date of receipt; — the batch number assigned after receipt; — any relevant comment; (b) a batch processing record which shall contain the following information: — the name of the product and batch number; — the dates and times of commencement, of critical intermediate stages, and of completion of production; — the batch number or analytical control number and quantities actually weighed of each material used; — an identification (e.g. by means of initials or another suitable system) of the operator who performed each significant step and, where appropriate, of the person that checked these operations; — a record of the in-process controls and the initials of the operator who carried them out; — details of the manufacturing operations carried out and identification of major equipment used; — the product yield obtained at relevant stages of manufacture; — notes on any problems or unusual events that may impact on the quality of the product, including relevant details, with signed authorisation for any deviation from the manufacturing instructions; — the approval of the batch processing record by the person responsible for the processing operations. Where a validated process is continuously monitored and controlled, the batch record may be limited to automatically generated reports with compliance summaries and exception or out-of- specification data reports; (c) a batch packaging record which shall contain the following information: — the name of the product and batch number; — the dates and times of the packaging operations; — an identification (e.g. by means of initials or another suitable system) of the operator who performed each significant step and, where appropriate, of the person who checked those operations; — records of checks regarding the conformity with the packaging instructions, including the results of in-process controls; — details of the packaging operations carried out and identification of major equipment and the packaging lines used; — whenever possible, samples of printed packaging materials used, including the batch coding, expiry date and any additional overprinting; — notes on any problems or unusual events that may have an impact on the quality of the product including details, with signed authorisation for any deviation from the packaging instructions; — the quantities and reference number or identification of all printed packaging materials and bulk product issued, used, destroyed or returned to stock and the quantities of obtained product, in order to provide for an adequate reconciliation. This information may be omitted where electronic controls are in place; — the approval of the batch packaging record by the person responsible for the packaging operations. 2. Records shall be made or completed at the time each action is taken and in such a way that all significant activities concerning the manufacture of veterinary medicinal products are traceable. 3. Logbooks shall be kept for major or critical analytical testing, for production equipment and for areas where a product has been processed. They shall be used to record in chronological order, as appropriate, any use of the area, equipment or method, calibrations, maintenance, cleaning or repair operations, including the dates and identity of people who carried out such operations. 4. Relevant records shall form the basis for assessment of the suitability for certification and release of a particular batch.