Dr Hiltrud Horn, Horn Pharmaceutical Consulting
Sabine Kuntz, bene Arzneimittel GmbH
Dr Bernd Renger, Immediate Past Chair of the EQPA
Dr Franz Schönfeld, Government of Upper Franconia
Axel Schroeder, Concept Heidelberg
Robert Schwarz, Shire
Timo Usinger, Vetter Pharma Manufacturing
During this course, experts from purchase, quality management, consultants and authorities will show you the critical fields of purchase and procurement for pharmaceutical manufacturing. Furthermore you become acquainted with examples of the coordination and practical implementation of the GMP requirements on QC, supplier qualification, packaging materials and maintenance. And last but not least, the speaker team provides you with information about the expectations of the responsible authorities and the relevant guidelines.
During the last years, the developments of computer technologies gave purchasers a lot of possibilities to optimise content management and merchandise management, reduction of suppliers. Direct connection with supplier systems enabled a faster, clearly arranged and more effective procurement. The World Wide Web, online tendering and auctions made the comparison of suppliers and costs easier than ever before.
But for the manufacturing of products under the regulations of drug licensing and GMP, like drug substances, drug products and medical devices, during all optimisation of purchase and procurement, purchasers must be aware of these regulatory requirements. Especially the change of suppliers, process relevant materials or parts of the qualified production plant must be planned in a direct cooperation with the quality management. Such changes necessities maybe a new validation of the process, a new qualification of the manufacturing plant and for sure, a change control procedure. This can effect additional costs, maybe more then the saving effect of the change and in a worst case, a not coordinated change can cause the lost of a product licensing.
This course is for people who are involved in purchase and procurement for GMP regulated manufacturing as well as for responsible persons from QC and QA who are in cooperation with the purchase and procurement of their companies.
Procurement for GMP manufacturing – Regulatory Requirements and Expectations
Where does GMP start? Procurement for Development and Clinical Phases
- Supplier Qualification
- Qualification and Validation
- Manufacturing and Import Licensing
- Marketing Authorisation
Qualification of Technical Suppliers - a Risk-based Approach
- 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
Supplier Contract Management
- Technical Equipment and Utilities
- Analytical Equipment & Reagents
- Supplies, Disposables and Consumables - What regulations apply?
- Risk-based qualification and procurement
Case Study: Purchase and Quality – Integration of both expectations in one Quality System
- Quality and Risk Management
- Technical Agreements
- cGMP Requirements
- Control of Content
GMP Requirements on Raw Materials
- 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
- Responsibility from a purchasing department
- Additionally responsibility from a pharma-purchasing department (handle the risk)
- Focus your strength
Purchase of production equipment under consideration of qualification requirements
- Regulatory Requirements
- Defense against legal claims
- We know what we want, purchasing department just has to negotiate the deal
- Purchase of production equipment – rational decision or based on gut good feelings?
- From URS to SAT – steps and pitfalls
GDP Effects on Procurement and Purchase
- What does it mean?
- Impact and Consequences?
- Examples for Typical Changes
Case Study: Changing consumables – Costs and Benefits shown by the examples from cleaning and disinfecting
- GDP requirements to manufacturer
- Ideas to handel the requirements
- Discussions between the involved departments
- GMP Requirements for Disinfectants
- Reasons for a Change and Challenges
- Validation and Costs