This course looks at the controls for starting materials, dispensing and processing, then it addresses what actions to take when confronted with a deviation and how to calculate yield and reconciliation.
Objectives
- Identify controls required for receiving, storing and dispensing starting materials
- Identify process controls in room and line clearance, formulation, in-process checks and batch records
- State GMP requirements for handling deviations
- Recognise how yield and reconciliation are calculated
Topics and Content
- Introduction
- Objectives
- Reviews and assessment
- Overview
- Starting material control
- What do you think?
- What do the GMP rules state?
- Overview
- Introducing starting materials to production
- 1. Receiving
- 2. Sampling and testing
- 3. Status labelling
- 4. Storing
- 5. Issuing
- Order these steps of starting material control
- When does direct control over product quality begin?
- Why are storage conditions critical to product quality?
- Dispensing control
- What do you think?
- What do the GMP rules state?
- Overview
- Dispensing process
- 1. Room clearance
- 2. Setup
- 3. Weighing
- 4. Clean-up
- When does room clearance occur?
- Select true or false for each statement
- Processing control
- What do you think?
- What do the GMP rules state?
- Overview
- Room and line clearance
- Introducing materials
- Formulation controls
- In-processing checks
- Monitoring processes
- Testing line samples
- Batch records
- Cleaning-up
- Examples of GMP regulatory citations
- Match the terms and activities
- Select true or false for each statement
- Deviations
- What do you think?
- What do the GMP rules state?
- Overview
- Handing deviations and CAPA
- Describe the deviation
- Yield and reconciliation
- Overview
- Theoretical yield and expected yield
- Actual yield
- Reconciliation
- GMP for yield and reconciliation
- Match the terms
- True or false?
- 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 steps of manufacture and production 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.
