The PIC/S has published a document to harmonise how inspectors assess quality risk management as detailed in ICH Q9.
Publication of the aide-memoir gives manufacturers an understanding of what inspectors are looking for when they assess implementation of quality risk management (QRM) at a plant. Exact details the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) looks for vary between facilities though.
“The level of effort, formality and documentation of the QRM-process should be commensurate with the level of risk. Expectations on the formality and extent of the application of QRM principles during the inspection will depend upon circumstances and the operations being examined”, PIC/S wrote .
PIC/S based the document on International Conference on Harmonisation (ICH) Q9 guidelines. ICH Q9 was adopted in November 2005 to improve implementation of risk-based approaches. Along with ICH Q8 and Q10 the guideline provides support for manufacturers adopting quality by design (QbD).
The aide-memoir is viewed as a continuation of the harmonisation process. While the main goal of the document is to assist GMP (good manufacturing practice) inspectors, in doing so it will also help harmonise the approach to QRM between the different PIC/S members.
PIC/S separates theaide-memoirinto five categories: overall systems; expectations on how QRM should be implemented; specific areas and activities where implementation of QRM might be expected; review of residual risk; and review and improvement of QRM activities.
Within each group the PIC/S lists bullet points of specific things to look for – such as is there evidence senior management is committed to QRM – and paragraphs of general advice for GMP inspectors.
“Inspectors should be cautious when reviewing assessments which include other business related risks, [such as environmental], in addition to quality risk assessments. Whilst these factors are important in a holistic sense there is a danger that they may compromise quality”, PIC/S wrote.