ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 6.5: Issue a checked, uniquely numbered batch production record for each batch, document each significant step, and investigate critical deviations and failures across related batches

What does 6.5 require?

A batch production record should exist for every intermediate and API batch, holding complete information on its production and control. Before issue it should be checked to be the correct, legible copy of the current master instruction (or, if produced from part of the master, reference the current master). Records should carry a unique batch or identification number and be dated and signed on issue; in continuous production the product code with date and time can serve until a final number is assigned. Each significant step should be documented with dates and times, major equipment used, identification of each input batch with weights and measures, actual results for critical process parameters, sampling done, signatures of those performing and supervising or checking critical steps, in-process and laboratory results, actual yields, packaging and label description, a representative label if sold commercially, any deviation with its evaluation and investigation, and release test results. Written procedures should govern investigation of critical deviations and batch failures, and the inquiry should reach any other batch that could be linked.