ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 8.1: Weigh and subdivide materials accurately into identified containers, witness critical operations, compare actual and expected yields, investigate deviations and show equipment processing status

What does 8.1 require?

Raw materials should be weighed or measured in conditions that leave them fit for use, using devices accurate enough for the purpose. Subdivided material should go into suitable containers labelled with the material name or item code, the receipt or control number, the quantity now in that container and, where relevant, the re-evaluation or retest date. Critical weighing, measuring or subdividing should be witnessed or subject to an equivalent control, and production staff should check before use that each material matches the batch record; other critical activities should also be witnessed or equivalently controlled. At designated steps, real yields should be checked against expected yields, which are set from laboratory, pilot or manufacturing data, and yield deviations at critical steps investigated for quality impact. Every deviation should be recorded with an explanation, and critical ones investigated. The processing status of major equipment should be shown on the unit or by documentation or system, and materials to be reprocessed or reworked controlled against unauthorised use.