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
Qualification of Technical Suppliers - a Risk-based Approach
- Technical Equipment and Utilities
- Analytical Equipment & Reagents
- Supplies, Disposables and Consumables - Which regulations apply?
- Risk-based qualification and procurement
Supplier Contract Management
- Quality– and Risk Management
- Technical Agreements
- cGMP Requirements
- Control of Content
Implementation of procurement in the Quality System – Practical aspects from Disposables to Equipment
- Risk based approach
- Life cycle management
- Procurement of disposables and materials versus purchase of equipment
- Required documentation and SOPs
Change Control
- What does it mean?
- Impact and Consequences?
- Examples for Typical Changes
Case Study: Purchase and Quality – Integration of both expectations in one Quality System
- Supplier Qualification
- Vetter – a Company Overview
- Balance of expectations
- Classic “Purchase” Processes
- Interaction and Communication between Purchase and Quality at Vetter
- Factors of Success
Documentation for GMP Materials – What is necessary? Retention Periods
- Regulatory Requirements
- Defense against legal claims
- Liabilities
- Limitations
Requirement on primary and secondary Packaging Materials
- Liabilities
- Limitations
- The challenge for packaging purchasing
- Regulations and their requirements for packaging materials
- New products and their applicators
- Extended challenges for packaging purchasing
Change Control
- What does it mean?
- Impact and Consequences?
- Examples for Typical Changes
GDP – Effects on Procurement and Purchase
- GDP requirements to manufacturer
- Ideas how to handle the requirements
- Discussions between the involved departments
Case Study: Changing consumables – Costs and Benefits shown by examples from cleaning and disinfecting
- GMP Requirements for Disinfectants
- Reasons for a Change and Challenges
- Validation and Costs