GAMP: Improving Efficiency and Effectiveness in Equipment Qualification and Validation of Process Control Systems
Monday 22 - Tuesday 23 March 2010
Seminar Leaders: Sandro De Caris,GAMP® Italia (Italy) and Hilary Mills-Baker, CEL (United Kingdom)
The session will focus on methods and approaches that can be applied to efficiently achieve and maintain
compliance during the lifecycle of equipment and control systems using the newest ISPE Guides (GAMP, VPCS,
C&Q, and GEP). Case histories will be presented by both users and suppliers focusing on efficiency and
effectiveness. The presentations will highlight targets already achieved, lessons learned and items to be
addressed in the future, in a continuous improvement approach.
Communities of Practice (COPs)
Commissioning and Qualification (C&Q), Engineering Standards Benchmarking (ESB), Good Automated
Manufacturing Practice (GAMP), Oral Solid Dosage (OSD), Packaging
Take Back to Your Job:
• Learn about innovative approaches to achieve pragmatic, efficient and effective practices aimed at
managing risk to product quality and patient safety
• Understand viewpoints of both suppliers and users, thus enabling collaborative relationships, leveraging
the supplier capabilities
• Learn from practical experiences how to integrate the application of the newest ISPE/GAMP Guides and
approaches in a modern and efficient methodology to manage automation projects involving equipment and
control systems. Case histories presented are efficiency-oriented and actually implemented on the field.
Who Should Attend:
• Professionals from the areas of Engineering, Quality Assurance/Validation, Project Management, and
Manufacturing Operations
Related Technical Documents:
• GAMP 5, GAMP Good Practice Guides on VPCS and Calibration Management, ISPE Good Practice Guide
on Good Engineering Practice
(GEP), and C&Q Baseline® Guide
• Articles produced by GAMP Italia and published in Pharmaceutical Engineering during 2007
Programme
Day 1, Monday 22 March
10.00 – 10.15 Welcome and Introduction
Sandro De Caris, GAMP Italia (Italy); Hilary Mills-Baker, CEL (United Kingdom)
10.15 – 10.40 Update on Guideline
Sandro De Caris, GAMP Italia (Italy)
• GAMP 5 key concepts
• User and supplier perspectives
• Integration of GAMP 5 and GAMP Good Practice Guides
10.40 – 11.15 Update on GPG Validation of Process Control Systems (VPCS)
Hilary Mills-Baker, CEL (United Kingdom)
• Specific contents of the new VPCS GPG
• Integration/harmonisation of VPCS with GAMP 5 Key concepts
• Current status
11.15 – 12.15 Applying Risk Assessment to Improve Validation Efficiency and Effectiveness of a
Packaged System
Karen Ashworth, Karen Ashworth Consulting Ltd, (United Kingdom)
• GAMP 5 risk assessment process
• Practical application of risk management
• How VPCS can help improve efficiency
• Case study for applying risk assessment to a packaged system
12.15 – 13.45 Lunch and Networking Break
13.45 – 14.45 Revamping of a Liquid Formulation Control System
Marco Mattei, Abbott (Italy), Anna Lidia Vignoli, CTP System (Italy)
• Enhancement of the control system with the introduction of a batch execution module
• Electronic management of production data for integration with a MES system
• Process knowledge as mandatory condition for definition of correct scalable approach
14.45 – 15.45 Applying PAT to a Solid Dose Process
Gianfranco Pugno, GlaxoSmithKline Manufacturing S.p.A. (Italy)
• Product and process understanding in the project phase (specification, CQA, CPPs, etc)
• PAT principles
• Case study: applying PAT to a real process (solid dose)
15.45 – 16.15 Coffee Break and Exhibition
16.15 – 17.15 Modular Design Approach for an Efficient Automation Project Development
Stefano Siviero, Merck-Serono (Switzerland) – tbc
• Modular design: from a single valve to a complete skid
• Standard libraries usage during the whole lifecycle: from concept to verification
• How modularity can improve efficiency in verification and maintenance activities
• Standardised design as a framework for package exchange among sites in the same organisation
17.15 – 17.45 Questions and Answers, Close of Day 1
Sandro De Caris, GAMP Italia (Italy); Hilary Mills-Baker, CEL (United Kingdom)
17.45 – 18.45 Exhibition Networking Reception
Day 2, Tuesday 23 March
09.00 – 09.15 Review of Day 1, Introduction of Day 2
Sandro De Caris, GAMP Italia (Italy); Hilary Mills-Baker, CEL (United Kingdom)
09.15 – 09.30 Update on GAMP Italia and Equipment Validation SIG
Sandro De Caris, GAMP Italia (Italy)
• The importance of the ISPE COPs and the benefits of the involvement in the COP activities
• GAMP COP as a meeting point for experience exchange
• Activities of the equipment validation SIG
09.30 – 10.30 Leveraging Supplier Involvement for a Common and Efficient Lifecycle
Marco Bellentani, MG2 S.r.l. (Italy); Beny Fricano, IMA S.p.A. (Italy)
• Re-use of supplier experience and documentation to optimise efforts and improve efficiency
• Practical use of risk-based decision during test planning
• Design of modular equipment and validation package
• Supplier support in maintaining the validated state in operation
10.30 – 11.00 Coffee Break and Exhibition
11.00 – 12.00 Leveraging GAMP Content in the Food Industry
Marco Silvestri, University of Parma (Italy)
• How to transfer GAMP principles from pharma to the food industry
• GAMP as a valuable tool for regulatory issues in aseptic packaging of low acid food
• GAMP in academia: courses, industrial projects and thesis
12.00 – 12.30 Questions and Answers
All speakers
12.30 – 12.45 Close of Seminar
Sandro De Caris, GAMP Italia (Italy); Hilary Mills-Baker, CEL (United Kingdom)
12.45 – 14.15 Lunch and Networking Break
14.15 – 17.45 Keynote Session 1