Q&As from the Live Online Training "Introduction to the AQCG's new AIQSV Guide" - Part 2

The ECA Analytical Quality Control Group (AQCG) has developed a new Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation. Version 1 of the new document was adopted at the ACQC Board Meeting in November 2023 in Düsseldorf/Neuss. The document was written by Dr Christopher Burgess (Chairman of the AQCG Board) and Dr Bob McDowall (Members of the AQCG Board and of the ECA IT Compliance Interest Group).

The Group organized a Live Online Training Introduction to the AQCG’s new ECA Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation on 29 April 2024. During the training, Dr Christopher Burgess and Dr Bob McDowall provided an insight into the new Guide and the rationale for the lifecycle approach. The training included a USP speaker update on the Analytical Procedure Lifecycle by Dr Amanda Guiraldelli-Mahr (Scientific Affairs Manager at USP).

In the Q&A session after the presentations, many interesting aspects were discussed. Part 2 of selected questions raised during the meeting are listed below with the teaching team's answers underneath. Part 1 (questions 1 to 7) can be found in our news archive.

Part 2 of the Questions and Answers

8. Starting from what USP category you need to have an URS rather than a description of intended use?

Answer: Groups B and C. 

The examples of the analytical balance and HPLC illustrate what is required for an analytical instrument. Software requirements are more extensive even for the Integrated Validation Document.

9. Where would you classify (record risk) the data for raw materials testing and environmental monitoring data?

Answer: It depends on what you are using raw materials and environmental monitoring for. Raw materials e.g. excipients are lower risk for topicals, going up for oral and highest for use sterile and aseptic products. Therefore, you could modify the risk assessment in the Guideline to include products made.

10. If electronic signatures function exists in the software, and it is turned on by default, you should not turn it on or turn it off, you can just decide to use it or to ignore it. Would it be category 3 or category 4 software in this case? Or the category will depend on your choice to use electronic signatures or not to use it?

Answer: Don't worry about the software category as use of electronic signatures will make your processes electronic and more robust that using a hybrid system. Of course, if you like using spreadsheets and transcription error checking carry on with the hybrid working!

11. If a qualification of an instrument fails, would you initiate and OOS, deviation, or...?

Answer: You do not have an OOS, in the usual sense of the term, in instrument qualification.

What you do have is a test failure which may also be a deviation.

However, the test failure must be documented in accordance with Test Plan and resolved (all data are part of the complete records of the qualification / calibration) and the qualification repeated. It is also essential to review the test step methodology before repeating the qualification. The usual method of documenting such an occurrence is via a File Note.

12. Because HPLC general chapters are not harmonized - the implication of this is that there is a difference in instrument compliance requirements between companies that export drug products and those that don't. For example, the Chinese Pharmacopeia HPLC general chapter contains NO instrument test requirements ! Another example - the Chinese Pharmacopeia GC general chapter states: The temperature controlled precision of the oven should be controlled +/- 1C, and fluctuations in temperature should not exceed 0.1 C per hour.

Answer: Sadly yes! However, your AIQSV procedure should cover your GC qualification requirements for all regulated markets. I have not seen this GC and am puzzled by the temperature fluctuation requirement which in my experience would be difficult, if not impossible, to achieve even with a Peltier thermostat!

13. How do you approach cloud-based environmental monitoring systems in laboratories?

Answer: The approach to any cloud-based system holding GMP data is the same. Think of cloud as your data on someone else's computer. The black hole analogy in the Q&A is also pertinent here. Carry out an assessment of the supplier do they meet Annex 11 requirements (see figure below)?

The agreement is crucial: who owns the data (i.e. you)? Can you decloud easily? Roles and responsibilities of each party defined? Escalation process? Performance and quality metrics of the service?

Above all, there must be a separate fail-over location in case of disaster - no secondary location - no agreement.