Recent changes to Schedule M of Indian Good Manufacturing Practice refer to guidelines of World Health Organisation . The applicable guidleine is WHO TRS 1019 Annex 3 published in 2019 provides guidelines on validation. Within this Annex, Appendices 5 and 6 cover validation of computerised systems and qualification of equipment respectively. Can these Appendices be applied to the practical and flexible qualification of analytical instruments and validation of laboratory computerised systems used in regulated Analytical Development and Quality Control laboratories? The answer is no.

The first part of the presentation will be a critique of these two appendices from WHO and why they are more applicable to production equipment and systems than those used in laboratories.

Next will be an introduction to United States Pharmacopoeia 1058 on Analytical Instrument Qualification effective in 2018 which offers a flexible, risk-based and integrated approach to AIQ for apparatus, instruments and systems. The USP is the only pharmacopeial to have a general chapter on AIQ.

USP 1058 uses a 4Qs model and a risk-based classification of items into one of three Groups A (apparatus), B (instruments) and C (systems) each with 2 or 3 sub-types. The basis of any qualification approach is the definition of intended use of an item from which the item is classified. This means that the qualification / validation approach can vary for the same make and model of instrument depending on the intended use in a laboratory. A flow chart will be presented to classify items with worked examples.

Intended use is defined in a user requirements specification (URS). USP 1058 states that for commercial instruments user requirements are expected to be minimal. The presentation will provide examples for common analytical instruments.

Considering Group C systems controlling analytical instruments usually consist of commercially available GAMP software category 3 and 4. Often a GAMP 3 software with limited functionality (e.g. UV-Vis spectrophotometer) can be validated with a single Integrated Validation Document (IVD) to save time and effort. How can a supplier’s software development and testing be used for reducing in-house validation of more complex software?

Lastly, USP 1058 is being updated and the 4Qs model will be replaced by a flexible three phase lifecycle. An example of a similar lifecycle from the European Compliance Academy Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation (AIQSV) will be presented. You will need to register for free membership of the Analytical Quality Control Group of ECA and then download this and other Guides free from: Documents - ECA Analytical Quality Control Group (analytical-quality-control-group.org). This is a 153 page document which has six appendices of how to examples for a variety of apparatus, instruments and systems.

Biography

Bob McDowall is an analytical chemist with over 50 years’ experience including 15 years working for two pharmaceutical companies, 30 years as a consultant and over 35 years CSV. Bob writes the Questions of Quality column for LCGC and Focus on Quality Column for Spectroscopy. He edited the first book on LIMS and is the 1997 LIMS Awardee. He has written two books on Validation of Chromatography Data Systems and one on Laboratory Data Integrity plus contributed to the GAMP Records and Data Integrity Guide and four GAMP Good Practice Guides.

He is the co-author of the draft of the current version of USP 1058 on Analytical Instrument Qualification (AIQ) as well as the co-author of the European Compliance Academy (ECA) Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation (AIQSV).

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