This course provides a solid introduction to Good Manufacturing Practice (GMP) for pharmaceutical products through control and management of manufacturing and quality.
Objectives
- 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
Topics and Content
- 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?
- 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
- Caring 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
Participants
This course is designed for induction of personnel new to GMP as well we refresher training for those already working in GMP operations.
Assessment / Certificate
There is a 10-question quiz assessment at the end of the course with a pass mark of 80% and 3 attempts.
A PDF Certificate is issued upon passing the quiz.
Duration
The course is expected to take approximately 1 hour.
Access
For organisations looking to setup once-off or ongoing training for group of personnel, SeerPharma can create a dedicated company account in our online Learning Management System (LMS) or we can licence courses for you to host in your own LMS or QMS. Request pricing for organisations.
For individuals and small groups, you buy now and your licence grants you access to the course for 30 days.
Contact us with any questions.
