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pharmaceutical, radiopharmaceutical, and biological) and those used to manufacture drugs for clinical trials are regulated under the Divisions 1A and 2, Part C of the guidelines, GUI-0104, are designed to facilitate compliance by the regulated industry and to enhance consistency in the application of the regulatory requirements.
It should be noted that these guidelines do not cover safety aspects for the personnel engaged in the fabrication, packaging/labelling, and testing of APIs and intermediates, or aspects of protection of the environment.
GMP are the part of quality assurance that ensures that APIs are consistently produced and controlled in such a way to meet the quality standards appropriate to their intended use, as required by the approved specifications in the market authorization of the drug in dosage form.
Quality control is the part of GMP that is concerned with sampling, specifications, testing, documentation, and release procedures.
Any other further processing steps after the APIs are in their final labelled container are subject to GUI-0001.