Procurement for GMP Manufacturing – Regulatory Requirements and Expectations
- Which regulations are applicable?
- Marketing authorisation
- Manufacturing and import licensing
- Supplier Qualification: equipment, starting materials, disposables and consumables
- Risk-based qualification and validation
Where does GMP start? Procurement for Development and Clinical Phases
- Considerations for EU and USA?
- Why should we know ICH Q7, Q8, Q9, Q10 and Q11?
- What is essential for development?
- Changes for routine manufacturing?
- Case study
Consumables for GMP Areas – “C-items” and their Impact
- What impact do consumables have in terms of cost and Quality?
- Specifications of the user and effective action of the purchasing department
- Risk assessment and evaluation in the event of a possible product change (change control)
- Possible internal cots, depending on the respective consumable, in the case of a product change.
GMP Requirements for Raw Materials
- What are raw materials?
- What is “pharmaceutical grade” for excipients?
- GMP for raw materials – risk assessment
- GMP requirements for final intermediate & APIs
- Supplier qualification & traceability
Requirements of Packaging Materials
- The challenge for packaging purchasing
- Regulations and their requirements for packaging materials
- New products and their applicators
- Extended challenges for packaging purchasing
Supplier Contract Management
- Quality and risk management
- Technical agreements
- cGMP requirements
- Control of content
- What does it mean?
- Impact and Consequences?
- Examples for Typical Changes
Documentation for GMP Materials – What is necessary? Retention Periods
- Regulatory requirements
- Defense against legal claims
Qualification of Technical Suppliers - a Risk-based Approach
- Technical equipment and utilities
- Analytical equipment & reagents
- Supplies, disposables and consumables - What regulations apply?
- Risk-based qualification and procurement
GDP Effects on Procurement and Purchase
- GDP requirements to manufacturer
- Ideas to handle the requirements
- Discussions between the involved departments