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 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: 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 Q4/2012. The course will include material from both of 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 directly user training and the writing of SOPs for operating the instruments or systems.