Procurement and Purchase meet GMP

3-4 May 2017

Vienna, Austria

Seminar Nr. 15987

Unser Seminarservice

Kosten

Die Veranstaltung hat bereits stattgefunden

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

Speakers

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

Objectives

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.

Background

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.

Target Group

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.

Programme

Procurement for GMP manufacturing – Regulatory Requirements and Expectations

Supplier Qualification
Qualification and Validation
Manufacturing and Import Licensing
Marketing Authorisation

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 - What regulations apply?
Risk-based qualification and procurement

Supplier Contract Management

Quality and Risk Management
Technical Agreements
cGMP Requirements
Control of Content

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

GMP Requirements on Raw Materials

Responsibility from a purchasing department
Additionally responsibility from a pharma-purchasing department (handle the risk)
Focus your strength

Documentation for GMP Materials – What is necessary? Retention Periods

Regulatory Requirements
Defense against legal claims
Liabilities
Limitations

Purchase of production equipment under consideration of qualification requirements

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

Change Control

What does it mean?
Impact and Consequences?
Examples for Typical Changes

GDP Effects on Procurement and Purchase

GDP requirements to manufacturer
Ideas to handel the requirements
Discussions between the involved departments

Case Study: Changing consumables – Costs and Benefits shown by the examples from cleaning and disinfecting

GMP Requirements for Disinfectants
Reasons for a Change and Challenges
Validation and Costs

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