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PharmTech.com Regulating Innovation, Quality, and Risk eBook January 2024 Pharmaceutical Technology ® 51 Qualit y Qualit y Quartets are also in place. Any risk assess- ments t hat a re per for med to help deter m i ne t he extent of commissioning and qualification testing that is required will likely be more straightforward a nd easier to per for m, given t he extent of equip- ment and process knowledge that is in place. O ver a l l , a nd a s i nd ic ate d a bove, t he conce pt of Qu a l it y Qu a r te t s i s u sef u l to con sider when deter m i n i ng how much for ma l it y to apply when per form ing risk assessments and when apply ing QRM pr i nciples to com m ission i ng a nd qua l i f ica- t ion ac t iv it ies. T he presence (or absence) of doc- u mented Qua l it y Qua r tet s for a m a nu fac t u r i ng process and its associated facilities, systems, and equipment can help a site understand the degree of uncer taint y t hat may be present as wel l as t he relative importance of various process parameters and items of equipment (or their components). This u nderst a nd i ng ca n i n for m r i sk a ssessment a nd QRM activities. But uncertaint y and importance are not the f ull picture; complexity considerations are also usef ul to think about, and as noted above, complexit y is a key fac tor t h at ICH Q 9(R1) refers to when one is determ ining how much forma lit y to apply to a given QRM activit y. ICH Q 9(R1) indicates that the more complex a process or subject area is to a QRM activit y, the higher the level of formalit y that may be appl ied to a ssure produc t qua l it y. T hus, w it h scenarios A through D, it is usef ul to also consider the level of complexit y that is associated with the facilit y, system, or equipment that may be subject to QRM activities. Conclusion This paper illustrates the benefits of applying the concept of Quality Quartets, as introduced in refer- ence 1, to the risk-based commissioning and qual- ification of manufacturing facilities, systems and equipment, and it discusses how t he g uidance in ICH Q 9(R1) in relation to subjectivity and formality in QRM can be applied in practical terms. A ll commissioning and qua lif ication activities involve making important decisions. For example, decisions need to be made about wh ich item s of equipment require qualif ication and which don't. Related decisions concer n how much leveragi ng ca n be m ade of f ac tor y accept a nce tes t i ng, a nd how much i n-house qua l i f icat ion test i ng w i l l be requ i red. T he 2019 ISPE Ba sel i ne Gu ide places a heav y emphasis on the use of QRM principles when commissioning and qualif ying facilities, systems, and equipment. ICH Q 9(R1) states that "ef fective risk-based decision making begins with determin- ing t he level of ef for t, forma lit y, and documenta- tion that should be applied during the QRM process" (2). T he g uidel i ne a lso i nd icates t hat add ressi ng "u ncer t a i nt y t h roug h t he use of k nowledge" not on ly faci l itates i n for med decisions, it a lso helps recog n i z e "where u ncer t a i nt y rem a i n s, so t h at appropriate risk controls may be identif ied." The scena r ios d isc ussed i n t h is paper i l lust rate how t hose concept s i n ICH Q 9(R1) ca n be d i rec t ly ap- pl ied when developi ng r isk-ba sed approaches to commissioning and qualification. This is through t he u se of a k nowledge m a n agement con s t r uc t ca l led a Qua l it y Qua r tet, wh ich is a const r uct of a site's knowledge about the relationship between certain CQAs, CPPs, CAs, and CDEs. To m a x i m i z e t he u sef u l ness of t he 2019 C&Q Baseline Guide, and ta k ing into account t he new g uidance t hat t he 2023 ICH Q 9(R1) g uideline pro- vides, the authors suggest that the Quality Quartet concept would be usef ul to consider when ma nu- f ac t u r i ng sites a re work i ng tow a rd s ac h ie v i ng tr ue risk-based commissioning and qualif ication of their facilities, systems, and equipment. Disclaimer statement The views expressed in this paper are those of the authors and should not be taken to represent the v iews of t he Hea lt h Products Reg ulator y Aut hor- ity (HPRA). References 1. Campbell, C. Quality Quartets in Risk-Based Qual- ification. Pharm. Technol. 2023 47 (5). 2. ISPE. Baseline Guide Vol 5: Commissioning & Qualifi- cation 2nd Edition (ISPE, June 2019). www.ispe.org 3. ICH. Q 9(R1), Qualit y Risk Management (ICH, Janu- ary 2023), www.ich.org 4. ICH. Concept Paper on the revision of ICH Q 9, No- vember 2020, www.ich.org 5. ICH. Q10, Pharmaceutical Quality System (ICH, June 2008), www.ich.org. 6. O'Donnell, K.; Zwitkovits, M.; Greene, A.; Calnan, N. Qualit y Risk Management–Putting GMP Con- trols First. PDA J. Pharm. Sci. Technol., 2012 May/ June, Vol. 66, No. 3. pp 243-261. 7. PIC/S. A Recommended Model for Risk-based Inspec- tion Planning in the GMP Environment, PI 037-1 (PICS, January 2012). ■ Asymchem Lab ........................................................................................5 Thermo Fisher Scientific ..........................................................................3 Ad Index COMPANY PAGE