ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 1.3-start: Designate and justify the point at which API production begins (the API starting material) and apply GMP from that step onward, with stringency rising towards final steps

What does 1.3-start require?

The company should decide, record and justify where API manufacture starts. For a synthetic route this is the step at which the API starting material (an input, whether a raw material, an intermediate or an API, built into the molecule as a significant structural fragment) enters the process; for fermentation, extraction, purification and similar routes the point is set case by case, using Table 1 as a guide. From that point the guide's GMP applies to the intermediate and API steps, including validation of the critical steps that affect API quality (validating a step does not of itself make it critical). Controls should tighten as the process moves from early steps to final isolation, purification and packing, and physical processing such as granulation, coating, milling or micronising should be run at least to the guide's standards. Steps before the starting material is introduced are outside the guide.