Sprecher
Dr Christopher Burgess, Burgess Analytical Consultancy, UK
Dr Bob McDowall, McDowall Consulting, UK
Zielsetzung
Analytical instrumentation used within GMP analytical laboratories is computerised either via firmware inside the instrument or via a workstation with software loaded on to a workstation that is situated next to the instrument. However, the current situation regarding the qualification of analytical instrumentation and validation of computerised systems is unsatisfactory; qualification and validation are typically considered as separate activities with little if any interaction between the two disciplines.
For example, the AAPS have produced guidance on analytical instrument qualification (AIQ) that has been incorporated as General Chapter <1058> within the United States Pharmacopoeia (USP). This focuses on the instrument with little emphasis on computerised system validation. In contrast, the GAMP Good Practice Guide for Validation of Laboratory Computerised Systems second edition looks exclusively on the computerised system and ignores the instrument qualification aspects entirely.
The major problem is that you cannot validate the computer system without qualifying the instrument and vice versa.
The teaching team have been actively involved in bringing AIQ and CSV together during 2011 - 3: they have written a stimulus for revision paper for USP <1058> that was published in the January-February 2012 issue of Pharmacopoeial Forum. Also they have been involved with input and writing sections of the second edition of the GAMP Good Practice Guide for Validation of Laboratory Computerised Systems published in November 2012. In addition they have redrafted USP <1058> and are co-authors of an article published in Pharmaceutical Engineering mapping the GAMP and USP <1058> approaches together. The course will include material from these publications.
In addition there is now the new version of Annex 11 in combination with Chapter 4 in Europe: what is the impact of these regulations on laboratory systems?
This workshop will address these current concerns and present an integrated approach to analytical instrument qualification (AIQ) and computerised system validation (CSV) for laboratory systems including the latest information with USP and GAMP. This will be achieved by presentations coupled with workshops and discussions to reinforce the presentation principles. The number of participants is limited.
Note: This workshop will not discuss user training and the writing of SOPs for operating the instruments or systems.
Zielgruppe
Analytical scientists, laboratory managers, validation personnel working with laboratory equipment and systems, quality assurance personnel and any IT personnel involved with systems such as chromatography data systems and LIMS.
Programm
Introduction to the Course
Aims and objectives of the course
Course process (presentations / workshops)
Road map for the course
A Risk-based Approach - Working Smarter not Harder
Quality Management Systems in the analytical laboratory; implications of ICH Q10
Traditional approaches to calibration, qualification & validation
Impact of new technology changes on instruments & systems
New and novel regulatory expectations
Equipment, Apparatus, Instrument or System?
Establishing ‘fitness for purpose’ and ‘suitability for intended use’
Terms and definitions; the role of a technical glossary
Analytical Instrument Qualification: Where Are We Now?
Calibration or Qualification?; Modular & holistic approaches
USP <1058> Analytical Instrument Qualification
USP <1058> Stimulus to the revision process paper
Establishing risk-based criteria based on user ways of working
Software linking in USP <1058> now and future: the new sub groups proposed
Applying the principles of USP <1058> in practice to an
Analytical balance
Stand alone spectrometer
HPLC with a networked CDS data system
Computerised System Validation: Where Are We Now?
Regulators
FDA; Part 11, Predicate Rules & 2002 software validation guidelines
EU; the New Annex 11 and Chapter 4 requirements
PIC/S Good practices for computerised systems in regulated “GXP” environments
Industry
GAMP 5: risk based approach
GAMP Good Practice Guides: Laboratory computerised systems 2nd Edition
Applying CSV principles to
Analytical balance
Stand alone spectrometer
HPLC with a networked CDS data system
An Integrated Approach to AIQ and CSV for Analytical Systems – Part 1
Do I have to qualify or validate?
The new USP <1058> proposed risk assessment process:
Define intended purpose
Record impact
Software classification
System categorisation
If I do how much do I do?
An Integrated Approach to AIQ and CSV for Analytical Systems – Part 2
How can I minimise the validation/qualification effort?
Threads and Phases of the Integrated Model of AIQ & CSV
Applying integrated approach principles to
Analytical balance
Stand alone spectrometer
HPLC with a networked CDS data system
Documenting the Qualification and Validation Effort
How much do I really need to do?
Key documents to be produced
“Validation Lite” a simplified approach for low risk systems
Paper or electronic documentation
Traceability of the validation/qualification effort
Supporting documentary evidence
Managing sign off and operational release
Linking with a Quality Management System (QMS)
Component Installation and Integration
Nomenclature & mapping; the USP <1058> 4 Qs & GAMP
Factory acceptance testing; strengths and weaknesses
Vendor documentation; pros & cons
Vendor installation & commissioning
Leveraging vendor activities to reduce user testing
Configuration management and the change control baseline
Managing the IT interface
Applying the principles to
Analytical balance
Stand alone spectrometer
HPLC with a networked CDS data system
Configuring the Application to Meet User Needs
Establishing laboratory work flows & SOPs
How good is the fit with vendor materials?
Prototyping to determine/ensure the fit to the
business process
Defining mandatory user requirements as a consequence of the workflow
Operational ranges & conditions
Calibration procedures and reference standards
Do you need a configuration document for
Analytical balance,
Stand alone spectrometer,
HPLC with a networked CDS data system?
What are the implications for change control?
User Acceptance Testing – Instrument, Software and System
What to test and what not to test
What has the vendor to offer?
Risk assessment and the URS
Typical aspects to test
Test plans and test scripts
Assumptions exclusions and limitations of testing
White box and black box testing
Testing approaches
Setting sound acceptance criteria
Integrating calibration and qualification
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