Procurement and Purchase meet GMP
Im Auftrag der ECA Academy

Procurement and Purchase meet GMP Im Auftrag der ECA Academy

Vienna, Austria

Seminar Nr. 17015


Kosten

Non ECA Member: EUR 1790,--
ECA-Member: EUR 1590,--
EU/GMP Inspectorates: EUR 895,--
APIC Member Discount: EUR 1690,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Andrea Hauser, University Hospital Regensburg
Dr Hiltrud Horn, Horn Pharmaceutical Consulting
Stephan Schmitt-Koopmann, sk pharma consulting
Dr Franz Schönfeld, Government of Upper Franconia
Axel Schroeder, Concept Heidelberg
Timo Usinger, Vetter Pharma Fertigung

Zielsetzung

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. 

Hintergrund

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 suppliers 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 than the saving effect of the change and in a worst case, a not coordinated change can cause the lost of a product licensing.

Zielgruppe

This course is for those 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.

Programm

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

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