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Guide to validation – drugs and supporting activities (GUI-0029)
: The Active Pharmaceutical Ingredient (API) is the core of the medicine. Its concentration in bulk mixes must be strictly monitored to ensure each final unit dose is accurate. Dosages Bulked Up GUI
Official guidance documents, such as those from Health Canada (GUI-0001) or ZAMRA , outline the standards for bulk drug handling: Guide to validation – drugs and supporting activities