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  • Describe a quality system model focusing on the management responsibilities, resources, manufacturing operations, and evaluation activities, and how they relate to GMPs.
  • Describe the classic V-Model and how it aligns testing activities to specification documents, to confirm that the equipment being validated is fit-for-purpose
  • Describe why regulatory audits inspect GMP requirements for Validation within pharmaceutical manufacturers and detail the typical documentation that will be required for such an inspection
  • Describe the characteristics of GMP that are embedded in the rules, regulations, and guidelines of the manufacturing process for a typical chemically derived Active Pharmaceutical Ingredients, OR for a typical Biopharmaceutical Protein Therapeutics, OR for a typical Medical Device
  • Describe the methodologies to generate, store and distribute purified water, and their relationship to the GMPs for manufacturing safe medicines, vaccines, or medical devices.
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