This course provides an overview of how GMP applies to the warehouse for receipt, storage, issue and distribution.
Objectives
- Explain the role of the warehouse
- List the GMP procedures needed in the warehouse to control incoming goods
- Identify the GMP requirements of handling starting materials and finished products in
the warehouse - Recognise the GMP issues surrounding release of finished products to the marketplace
- Recognise issues around transport of goods to and from the public
- Recognise how to handle returns
- Identify the different documentation needed in the warehouse
Topics and Content
- Introduction
- GMP for the warehouse
- GDP and GWP
- Objectives
- Reviews and assessment
- Role of the warehouse
- What do you think?
- What do the GMP rules state?
- GMP for the warehouse
- What comes into the warehouse?
- Typical warehouse layout
- Repacking
- Personnel and training
- Preventing contamination and deterioration
- Preventing mix-ups
- Segregation
- In the BOM or not in the BOM?
- GMP rules for the warehouse
- What do you think?
- What do the GMP rules state?
- General GMP rules
- Housekeeping
- Unique Identification
- Status labels
- Product labels
- Storage requirements
- Protecting materials
- Pest control
- Air control
- Temperature control
- Cold storage
- Other sensitive materials
- Enter the missing words to complete this housekeeping phrase
- Select true or false for each statement
- Match the label information
- Receipt and issue to manufacturing
- What do you think?
- What do the GMP rules state?
- Approving suppliers
- 5-step process (receipt to production)
- Receiving starting materials
- Material Safety Data Sheet (MSDS)
- Receiving printed materials
- Storing materials
- Issue of materials
- Stock rotation
- Defective and expired materials
- MSDS - what is it good for?
- True or false?
- When does direct control over product quality begin?
- Finished product and handling returns
- What do you think?
- What do the GMP rules state?
- Overview
- Release process
- Picking, packing and dispatching
- Transportation and distribution
- Customer returns
- Managing recalls
- Ordering the process
- Select true or false for each statement
- Documentation
- What do you think?
- What do the GMP rules state?
- Traceability
- Purchase Orders (POs)
- Inward Goods
- Internal audit / Self-inspection
- Conclusion
- Regulatory inspection findings
- Summary
Participants
This course is designed for induction of personnel new to GMP warehouse operations (e.g. inwards goods, material picking and issue to production) as well we refresher training for those already working in GMP warehouses.
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.
