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Pharmaceutical Manufacturing Handbook: Production and Processes, Unit operations are defined as the individual basic steps in a process that when. Linking Material Attributes and Process Parameters to Drug Substance CQAs . purge of impurities through every step of a manufacturing process. opment, manufacturing, and quality assurance steps through innovation in product and process development, process control, and analysis.Manufacturing plans address operations from the receipt and manufacturing of materials to production, packaging, labeling, relabeling, storage and distribution, Pharmaceu- tical manufacturing is divided into two major stages: the production of the active ingredient or drug (primary processing, or manufacture) and. Good Manufacturing Practice for Active Pharmaceutical Ingredients. Step 5 process steps may be subject to GMP but are not covered by this Guide.