“Why cGMP’s are Required to Consistently Manufacture Safe Medicines, Vaccines and Medical Devices”: Manufacturing Safe Medicines & Medical Devices, (GMP), WIT, Ireland

“Why cGMPs are Required to Consistently Manufacture Safe Medicines, Vaccines, and Medical Devices”

⦁ Introduction – 200 words
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 issue 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.

Big Idea 4 – Cleaning Approaches and their Validation – 400 words

What do I need to cover in this Big Idea:

⦁ (Major Supporting Point a) Cleaning – Mechanical and Chemical Approaches – 200 words
Discuss how to clean and decontaminate surfaces using CIP (clean-in-place), immersion, automated parts washers, ultrasonic cleaning, and manual cleaning, in addition to the chemical aspects of solubility, oxidation, etc.

⦁ (Major Supporting Point b) Cleaning Validation – 200 words
Describe how a typical cleaning validation sequence determines the cleanliness levels of surfaces coming into contact with the product, and how it aligns with the cGMPs for manufacturing in a regulated environment.

Big Idea 5 – Cleanrooms – 400 words

What do I need to cover in this Big Idea:

⦁ (Major Supporting Point a) Cleanroom Layout – 200 words
Describe a cleanroom configuration from the perspective of airflow direction, filter arrangements, cleanroom gowning, and personnel and material flows – to both contain high potency medicines from escaping into the environment, as well as preventing their contamination from external sources.

⦁ (Major Supporting Point b) Cleanroom Classification, Protection & Monitoring – 200 words
Discuss the range of airlock configurations typically used to maintain the critical environmental zones of cleanrooms, their impact on controlling the risk of contamination, and how they maintain product quality. In addition, discuss the relationship between the physical tests used to monitor cleanroom environments (e.g. pressure differentials, airflow velocity, etc,) to the GMPs required to consistently manufacture safe medicines, vaccines and medical devices.

Big Idea 6 – Quality Risk Management – 400 words

What do I need to cover in this Big Idea:

⦁ (Major Supporting Point a) Quality Risk Management – 200 words
Discuss how science based decisions can be made using the 4-step risk management process below:
⦁ Identify major risks with respect to product quality and patient safety.
⦁ Evaluate and prioritize the list of faults.
⦁ Decide what risks are currently acceptable, and subsequently decide on a suitable mitigation strategy(s) for priority risks.
⦁ List a post-implementation review strategy that ensures both successful risk-mitigation strategy(s) and identifies any new risks.

⦁ (Major Supporting Point b) Documenting the Quality Risk Management Process – 200 words
Discuss the relationship between documenting the overall risk management process to support the scientific basis of decisions made when deviations occur in the manufacturing process and the GMPs for maintaining product quality and patient safety.

Big Idea 7 – Any Other Big Idea – 400 words

Feel free to pick any other Big Idea covered in your course:

⦁ (Major Supporting Point a) Any Other Topics – 200 words
Use your course content to support your big idea and how it relates to GMPs for the manufacture of safe medicines, vaccines, and medical devices.

⦁ (Major Supporting Point b) Any Other Topics – 200 words
Use your course content to support your big idea and how it relates to GMPs for the manufacture of safe medicines, vaccines, and medical Devices.