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 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.
Conclusion – 200 words