This course looks at the GMP requirements for the control of packaging materials and packaging operations.
Objectives
- Define mislabelling
- State requirements for packaging controls
- Describe GMP controls for pre-printed matter
- Identify GMP requirements of setting up a packaging line
- State the importance of on-line controls
- Perform basic reconciliation calculations
Topics and Content
- Introduction
- Objectives
- Reviews and assessment
- Overview
- Mislabelling
- What do you think?
- What do the GMP rules state?
- Overview
- Packaging controls
- Labelling recalls
- Printed material control
- What do you think?
- What do the GMP rules state?
- Overview
- Printing
- Receiving printed material
- Issue, coding and returns
- Match the controls to the process stages
- Select true or false for each statement
- Line clearance and setup
- What do you think?
- What do the GMP rules state?
- Overview
- Line clearance
- Line setup
- Clean-up
- Order these steps for a given batch
- True or false?
- What is the difference between line clearance and line clean-up?
- Online controls
- What do you think?
- What do the GMP rules state?
- Overview
- Checking fill volume and seal integrity
- Run charts
- Control charts
- For the 5 bottles examined, which is the best deviation description?
- Which checks are required during packaging operations?
- Select all that apply
- Reconciliation
- What do you think?
- What do the GMP rules state?
- Overview
- Calculating reconciliations
- Reconciliation walk-through
- Unsatisfactory reconciliation may indicate what?
- Select all that apply
- Select true or false for each statement
- Conclusion
- Summary
Participants
This course is designed for induction of personnel new to GMP or as a refresher for experienced GMP personnel in roles relating to packaging materials and packing processes of medicines.
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, you can buy now for $149 (ex GST) and your licence grants you access to the course for 30 days.
Contact us with any questions.
