Certificates of analysis
Article 47
1. Upon request, certificates of analysis shall be issued for each batch of intermediate or active substance. 2. The certificate of analysis shall contain at least: (a) the name of the intermediate or active substance including, where appropriate, its grade; (b) the batch number; (c) the date of release; (d) the expiry date for intermediates or active substances with an expiry date; (e) the retest date for intermediates or active substances with a retest date; (f) each test performed in accordance with compendial or customer requirements, including the acceptance limits, and the numerical results obtained, if appropriate. 3. Certificates shall be dated and signed by authorised personnel of the quality unit and shall include the name, address and telephone number of the original manufacturer. 4. Where the analysis has been carried out by entities involved in repackaging or reprocessing, the certificate of analysis shall include the name, address and telephone number of the entity involved in repackaging or reprocessing and a reference to the name of the original manufacturer. 5. Whenever new certificates are issued by or on behalf of entities involved in repackaging or reprocessing, those certificates shall include the name, address and telephone number of the laboratory that performed the analysis. They shall also contain a reference to the name and address of the original manufacturer and to the original batch certificate, a copy of which shall be attached.