Describe why regulatory audits inspect GMP requirements for Validation within pharmaceutical manufacturers, and detail the typical documentation

Introduction 

Big Idea 1 – GMPs, Regulations and Quality Systems – 400 words

What do I need to cover in this Big Idea:

(Major Supporting Point a) Good Manufacturing Practices – 200 words
Describe the content of a typical GMP, and identify some regulatory agencies that issues them (e.g. ISO, FDA, etc.).

(Major Supporting Point b) Quality Systems Approach to cGMP Regulations – 200 words
Describe a quality system model focusing on the management responsibilities, resources, manufacturing operations, and evaluation activities, and how they relate to GMPs.

Big Idea 2 – GMP Requirements for Validation – 400 words

What do I need to cover in this Big Idea:

(Major Supporting Point a) Validation and the V-Model – 200 words
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

(Major Supporting Point b) PQ, OQ and IQ Documentation needed for Inspections – 200 words
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

Big Idea 3 – Manufacturing Regulations as they relate to GMPs – 400 words

What do I need to cover in this Big Idea:

(Major Supporting Point a) Manufacturing Rules, Regulations & Guidelines – 200 words
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 (API), OR for a typical Biopharmaceutical Protein Therapeutics, OR for a typical Medical Device

(Major Supporting Point b) Purified Water Generation, Storage & Distribution – 200 words
Describe the methodologies to generate, store and distribute purified water (PUW), and their relationship to the GMPs for manufacturing safe medicines, vaccines or medical devices.