This course looks at the role of GMP documentation in providing a history of manufacturing from supplier to customer, including the requirements of master instructions, Standard Operating Procedures (SOPs), batch records, quality control records and how to complete GMP records.
Objectives
- Recognise the importance of procedures
- Recognise the importance of record keeping
- Identify the possible consequences of not completing and certifying GMP documents
- Identify how to complete batch records and associated supporting documents
Topics
- Introduction
- Requirements
- GMP documentation
- Record keeping
- Case study
- Conclusion
Participants
This course is designed for induction of personnel new to GMP or as a refresher for experienced GMP personnel because good documentation and record keeping practices apply to all 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.
Your licence grants you access to the course for 30 days.
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Completion
The following certificates are awarded when the course is completed:
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Certificate of Completion |
