ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 6.4: Prepare master production instructions for each intermediate and API, signed by one person and independently checked and signed by the quality unit, with the full content set

What does 6.4 require?

To keep batches uniform, each intermediate and API should have master production instructions written, dated and signed by one person, then separately checked, dated and signed by a member of the quality unit. They should give: the product name and a document reference code; the full list of raw materials and intermediates, with names or codes specific enough to show special quality characteristics; the quantity or ratio of each with units (and calculations for variable batch sizes, with justified variations); the production location and major equipment; detailed instructions on sequences, process parameter ranges, sampling and in-process controls with acceptance criteria, time limits for steps or the whole process, and expected yield ranges at suitable stages; special notations and precautions or cross-references; and storage instructions for the product including label and pack materials and any special storage conditions with time limits.