ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 11.4: Issue authentic, signed certificates of analysis on request that show the product, batch, release date, dating, each test with limits and numerical results, and the original manufacturer

What does 11.4 require?

On request, a genuine certificate of analysis should be provided for every intermediate or API batch, giving the product name and grade where relevant, batch number and release date, and the expiry date (on label and certificate) or the retest date (on label and/or certificate). Each test performed to compendial or customer requirements should be listed with its acceptance limits and numerical results where numerical. Each certificate should carry the date and signature of authorised quality unit staff and show the original manufacturer's name, address and telephone number. Where a repacker or reprocessor did the analysis, the certificate should show its details with reference to the original manufacturer; new certificates issued by or for repackers, reprocessors, agents or brokers should identify the laboratory that tested, refer to the original manufacturer and the original batch certificate, and attach a copy of it.