+44 7706281187
Jan 27, 2022
  • 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.

Order this Assignment now

Total: GBP120

fables template