Description
This cGMP: Introduction to Good Manufacturing Practice (GMP) course includes sections on:
- Introduction to current good manufacturing practices (cGMPs)
- Maintaining product quality
- Scope of GMP rules
- Cleaning and sanitation
- Proper documentation
- Summary.
The course explores a list of essential packaging and production controls, reviews guidelines detailing the proper way to execute GMP records, describes GMP personal hygiene requirements, clarifies the four key product quality attributes, explains the purpose of GMP codes and regulations, and offers explanations of why companies are required to follow GMP guidelines, and the consequences if they do not.
Introduction
– What is GMP?
– Objectives
– Reviews and assessment
– Events that have shaped GMP
– Evolution of GMP
– Introduction to GMP codes
– GMP regulatory bodies (EMA, FDA, Health Canada, Medsafe, MHRA, PIC/S, TGA, WHO)
– Specific GMPs (FDA, EU, PIC/S)
– What is GxP?
– Why are GMPs important? Select all that apply.
– GMP stands for?
– Match the GMP regulatory body to the region Quality
– What do you think?
– What do the GMP rules state?
– What is product quality?
– Purity
– Identity
– Effectiveness
– Safety
– Why does quality matter?
– Pharmaceutical Quality System (PQS)
– Select true or false for each statement
– Fill in the blanks
Scope of GMP rules
– What do you think?
– What do the GMP rules state?
– Scope by EU and PIC/S Guide to GMP chapters
– Comparing GMPs of the EU and PIC/S with the FDA
– Personnel and training
– Premises
– Equipment
– Manufacturing areas
– Manufacturing controls
– Self inspection / internal audit
– How much is true?
– What’s the impact?
– Why are self inspections needed?
Cleaning, hygiene and gowning
– What do you think?
– What do the GMP rules state?
– Housekeeping
– Cleaning and sanitation
– Personal hygiene and gowning
– Topic review
Documentation
– What do you think?
– What do the GMP rules state?
– Proof of product quality
– Manufacturing records
– Rules for completing records
– Which correction is correct?
– Electronic data
– Data integrity
– True or false?
– Select all that apply
Conclusion
– Summary
Objectives:
This course provides a solid introduction to control and management of manufacturing and quality of pharmaceutical products.
– Explain why your company has implemented GMP
– State the purpose of GMP regulations
– State the four key product quality attributes
– State the requirements for personal hygiene
– Describe the correct way to complete records
– List the essential production and packaging controls
