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VOL. 34 NO. 1 (2022)
QUALITY MATTERS
Four generations of quality: a new
approach
John P. Hammond
Technical Manager, Starna Scientific Limited, 52–54 Fowler Road, Hainault, Essex IG6 3UT, UK
Introduction this series of articles is no different. pharmacovigilance and by agencies
As stated in the last article, this Discussed below are two new areas regulating these industries.
article marks a change in this series of interest, their associated termi- In recent years, certaintly since
because from this point forward, we nology, standards and guidance on the publication of the revised ISO/
will concentrate on specific areas of the topic. IEC 17025:2017 standard,1 “Risk
interest in the Quality environment Management” is one of these new
in which we are/will be working in The “new” quality topics. It is included in ISO/IEC
the future. “tools” of Analysis 17025 as section “8.5 - Actions to
As an unexpected consequence of Risk and Lifecycle address risks and opportunities”
of the COVID-19 Pandemic, the Management where specifically in 8.5.2 it states:
enforced isolation of the last two Whilst neither of these concepts 8.5.2 The laboratory shall plan:
years has allowed time for reflec- can be described as new in the a) actions to address these risks
tion in all aspects of life. In the fundamental definition of the term, and opportunities.
scientific area, the postponement their use and application in our b) how to:
or reassignment to virtual events areas of interest certainly is. — integrate and implement these
of major international conferences, actions into its management
e.g. Pittcon 2022 at the time of Analysis of Risk system.
writing this article, has prompted In a simple definition, risk may — evaluate the effectiveness of
an explosion of on-line webinars, be defined as the combina- these actions.
presentations etc. on a whole host tion of the probability of occur- NOTE Although this document
of topics, and the Quality environ- rence of harm and the severity of specifies that the laboratory plans
ment is no exception. Available to that harm. However, achieving a actions to address risks, there is no
a much wider audience than by shared understanding of the appli- requirement for formal methods
physical attendance at a confer- cation of risk management among for risk management or a docu-
ence, this “information explosion” diverse interested parties is diffi- mented risk management process.
in these areas of interest is summa- cult because each stakeholder Laboratories can decide whether
rised below and reinforced by the might perceive different potential or not to develop a more extensive
author’s direct involvement in these harms, place a different probability risk management methodology
areas of interest. on each harm occurring and attrib- than is required by this document,
Regular readers of this Quality ute different severities to each e.g., through the application of
Matters column will be familiar harm. In addition, subjectivity can other guidance or standards.
with the regulatory environments directly impact the effectiveness of So, we now have “considera-
and standards often discussed by risk management activities and the tion of risk” incorporated into this
the authors; and in that respect decisions made. fundamental quality standard, and
However, as stated below, in whilst the note states that there
regulated environments there is is no requirement for formal risk
DOI: 10.1255/sew.2022.a4 clearly an increasing perception as management, we live in an evolv-
© 2022 The Author to the benefit of the analysis of risk ing World, and I’ll leave you to draw
associated with any given process, your own conclusions.
Published under a Creative and, therefore, risk management So, this has elevated the role
Commons BY-NC-ND licence principles are effectively utilised in of Risk Management in modern
many areas of business and govern- Quality Management systems,
ment including finance, insurance, because just like we have learnt to
occupational safety, public health, distinguish between “Variants of
40 SPECTROSCOPYEUROPE www.spectroscopyeurope.comVOL. 34 NO. 1 (2022)
QUALITY MATTERS
Interest” and “Variants of Concern” the appropriate structures and and manufacturing. A proactive
in this pandemic, “guidance” is often terminology. approach to quality risk manage-
perceived exactly as stated, i.e. ICH Q9(R1) is a draft revision of ment facilitates continual improve-
additional information for consider- the document first produced on ment and is of strategic importance
ation, but as soon as this becomes 9 November 2005, and currently in achieving an effective pharma-
stated as a requirement within a open for public comment as this ceutical quality system. Additionally,
standard, it takes on a whole new revision (R1) until 15 March 2022. use of quality risk management can
meaning. Within the pharmaceutical indus- improve the decision making if a
On a related topic, it will be inter- try, the principles and framework of quality problem arises.
esting to see how the ISO remit of ICH Q9, coupled with the official In the development phase, quality
ISO TC/334 to convert the ISO/ ICH training material that supports risk management is part of building
REMCO Guides into corresponding this guideline, are instrumental in knowledge and understanding risk
standards is perceived, but that’s a enhancing the application of effec- scenarios, so that appropriate risk
discussion for another article/day. tive quality risk management by control can be decided upon during
Thereafter, two more recently industry and regulators. As previ- technology transfer, for use during
published documents also for ously stated on many occasions, the commercial manufacturing
consideration are ISO 31000:20182 quality systems are a fundamental phase. In this context, knowledge is
and ICH Q9(R1).3 requirement in the pharmaceutical used to make informed risk-based
To assist organisations in imple- industry, and it is evident that qual- decisions, trigger re-evaluations
menting risk management in a ity risk management is a valuable and stimulate continual improve-
structured manner, ISO have added component of an effective quality ments.
“ISO 31000:2018 – Risk manage- system. Effective and proactive qual-
ment – A practical guide” to their If we customise the previously ity risk management can facilitate
portfolio of standards, and have described ISO interested parties/ better, more informed and timely
made freely available in electronic stakeholder statement in rela- decisions throughout the lifecycle.
format (.pdf) a guidance document tion to pharmaceuticals—although This can provide regulators with
for ISO 31000:2018.4 The aim of there are a variety of stakehold- greater assurance of a company’s
this standard is to assist organisa- ers, including patients and medical ability to deal with potential risks
tions seeking guidance on how to practitioners as well as govern- and avert problems and can bene-
integrate risk management into ment and industry—the protection ficially affect the extent and level of
their activities. The handbook, of the patient by managing the risk direct regulatory oversight.
therefore, includes information on to quality and availability, when The application of digitisation
risk management principles, the availability risks arise from quality/ and emerging technologies in the
framework, roles and responsibili- manufacturing issues, should be manufacture and control of medici-
ties, planning, processes, communi- considered of prime importance. nal products can present certain
cation, monitoring and review, and The manufacturing and use of a challenges. The application of qual-
continual improvement; and was drug (medicinal) product, including ity risk management to the design,
written for those who are either its components, necessarily entail validation and technology transfer
starting their risk management jour- some degree of risk. The risk to of advanced production processes
ney or require additional guidance its quality is just one component and analytical methods, advanced
on how to improve their current, of the overall risk. It is important data analysis methods and comput-
risk management programme. to understand that product qual- erised systems is important.
In the standard itself, ISO 31000 ity is assured based on appropri- In this revision of ICH Q9 the
explains the fundamental concepts ate risk-based decision-making following paragraph uses the term
and principles of risk manage- throughout the product lifecycle, “lifecycle”, as discussed below.
ment, describes a framework, and such that the attributes that are The purpose of this document is
outlines the processes of risk iden- important to the quality of the drug to offer a systematic approach to
tification and management. ISO (medicinal) product are maintained quality risk management for better,
31000 is supplemented by IEC and the product remains safe and more informed, and timely decisions.
31010:2019, “Risk management – effective. An effective quality risk It serves as a foundation or resource
Risk assessment techniques” and management approach can further document that is independent of,
ISO 31073, “Risk management – ensure the high quality of the drug yet supports, other ICH Quality
Vocabulary”, and, therefore, with (medicinal) product to the patient documents and complements exist-
this set of three standards, effec- by providing a proactive means ing quality practices, requirements,
tive risk management can be to identify and control potential standards, and guidelines within
planned, and implemented, using quality issues during development the pharmaceutical industry and
www.spectroscopyeurope.com SPECTROSCOPYEUROPE 41VOL. 34 NO. 1 (2022)
QUALITY MATTERS
regulatory environment. It specifi-
cally provides guidance on the prin- Initiate
ciples and some of the tools of quality Quality Risk Management Process
risk management that can enable
more effective and consistent risk- Risk Assessment
based decisions, both by regulators
Hazard Identification
and industry, regarding the quality of
drug substances and drug (medicinal)
products across the product lifecy- Risk Analysis
cle. It is not intended to create any
new expectations beyond the current
Risk Evaluation
regulatory requirements. An under-
standing of formality in quality risk unacceptable
Risk Communication
management may lead to resources
being used more efficiently, where Risk Control
Risk Management
lower risk issues are dealt with via less
formal means, freeing up resources Risk Reduction
Tools
for managing higher risk issues and
more complex problems that may
require increased levels of rigour and Risk Acceptance
effort. An understanding of formality
can also support risk-based decision-
making, where the level of formality
Output Result of the
that is applied may reflect the degree Quality Risk Management Process
of importance of the decision, as well
as the level of uncertainty, complex-
ity and criticality which may be pres-
Risk Review
ent. Appropriate use of quality risk
management can facilitate but does Review Events
not obviate industry’s obligation to
comply with regulatory requirements
and does not replace appropriate
Figure 1. Risk Management cycle. Redrawn from ICH Q9(R1).3 © European
communications between industry Medicines Agency, 2021
and regulators. Quality risk manage-
ment should not be used in a manner
where decisions are made that justify Performance Qualification, Significantly, and to bring
a practice that would otherwise, in and Procedure Performance this discussion up to date, USP
accordance with official guidance Verification5 General Chapter has been
and/or regulations, be deemed unac- 2) Fitness for Use: Decision processed through the USP voting
ceptable. Rules and Target Measurement and review process and becomes
Uncertainty6 an official chapter on 1 May 2022.
Lifecycle Management 3) A n a l y t i c a l Ta r g e t P ro b e : A synopsis of this new chapter is
During the 2015–2020 cycle, Structure and Application as follows:
within the Expert Committee struc- Throughout the Analytical Analytical Procedure Life
ture of USP, an Expert Panel was Lifecycle7 Cycle. This new chapter presents an
formed to investigate the exten- 4) Analytical Control Strategy8 enhanced framework for analytical
sion of PAT and QbD principles into 5) Proposed New USP General procedures that holistically incorpo-
the analytical arena. The output Chapter: the Analytical rates all the events that take place
from this Analytical Procedure Life Procedure Lifecycle 9 over the procedure lifecycle that
Cycle Expert Panel resulted in the This set of Stimuli articles summa- are designed to demonstrate that
following Stimuli articles, published rised the Lifecycle approach and its a procedure is, and remains, fit for
on this topic in the Pharmacopeial implementation in the Analytical the intended purpose.
Forum. arena, culminating in the final Validation of an analytical proce-
1) Lifecycle Management of version of the new USP General dure is defined in Validation of
Analytical Procedures: Method Chapter covering this topic Compendial Procedures
D e v e l o p m e n t , P ro c e d u re published in Pharmacopeial Forum.10 as “the process by which it is
42 SPECTROSCOPYEUROPE www.spectroscopyeurope.comVOL. 34 NO. 1 (2022)
QUALITY MATTERS
established, by laboratory stud- connections through the lifecycle Analytical Instrument Qualification
ies, that the performance char- approach. 1058. Qualifying the operation
acteristics of the procedure meet The concept of the analyti- and performance of an analyti-
the requirements for the intended cal procedure lifecycle is not cal instrument/system is a critical
analytical applications”. Generally entirely new. Some compo- part of a robust quality manage-
regarded as an event not a nents are described in the chap- ment system and is required in
sequence of events or activities ters mentioned previously, as well a current good manufacturing
being part of a journey from devel- as Statistical Tools for Procedure practice (GMP) environment. In
opment to retirement. Validation , and the concept pharmacopeial applications, the
International Council for is aligned with quality by design performance of an instrument
Harmonisation guideline ICH concepts. or system directly impacts the
Q2(R1) similarly defines “the objec- The evolutionary process of this data reported by establishing the
tive of validation of an analytical whole area of interest, is shown by reportable value of an analytical
procedure is to demonstrate that it this statement in the stim- test characteristic specified in a
is suitable for its intended purpose”. uli article: monograph. For this reason, USP’s
Considering these definitions The Analytical Procedure Life Cycle Analytical Instrument and System
more broadly, all activities that Expert Panel acknowledged that Qualification Joint Subcommittee
confirm that a procedure is suita- some of the life cycle concepts (AISQ JSC) is considering not only
ble for the intended purpose that may evolve as ICH Q14 guid- possible enhancements to 1058,
take place over the entire life of the ance is developed and ICH Q12 but also the impacts on analyti-
procedure can be considered under guidance is implemented. General cal instruments chapters below
the validation umbrella. Some chapter will be re-evalu- 1000, as well as other general
of these activities are currently ated for content and terminology chapters. As an example, Figure 1
described in Transfer of Analytical when ICH Q14 guidance is final- (see Reference 11) illustrates the
Procedures , ized and aligned where possible. In nature of these interdependencies
and Verification of Compendial the interim, this chapter provides for a number of the currently offi-
Procedures , which provide a general framework that encom- cial spectroscopic general chap-
guidance for formal validation, passes the entire procedure life ters.
transfer and verification of analyti- cycle that can be applied where The primary purpose of this Stimuli
cal procedures. These are important practical. to the Revision Process (SRP) article,
activities that provide assurance Having established the new is to share the JSC’s current think-
that an analytical procedure is suit- “Lifecycle” chapter, in the 2020– ing on AISQ within the USP–NF with
able for the intended purpose in the 2025 cycle the newly formed all stakeholders, and to gain input on
laboratory where the procedures Analytical Instrument and System potential revisions and enhancements
will be used. However, they are Qualification Joint Subcommittee to 1058. The discussion is focused on
often treated as discrete activities (AISQ JSC), risen as the phoenix the spectroscopic general chapters
that are completed at certain points from the ashes of the Life Cycle series 85x and 185x. The JSC intends
in the life of a procedure and may Expert Panel, turned its atten- to publish two additional SRPs, where
not be considered holistically. As tion to expanding the approach the second will present the topic of
such, these events can be discon- to the Qualification of Analytical Target Measurement Uncertainty
nected from each other and from systems, and has recently published (TMU), which is outlined later in the
other activities that are intended on 3 January 2020, a Stimuli arti- SRP article, and the third will expound
to confirm the procedure remains cle titled: “Analytical Instrument in more detail the qualification cycle
fit for the intended purpose. These and System (AIS) Qualification, of Analytical Instrument and Systems
other activities include establishing to support Analytical Procedure (AIS).
and ensuring adherence to proce- Validation over the Life Cycle”
dure controls such as system suit- the Abstract summary of which is 4th Generation: from
ability, implementing an appropriate stated below: 2021 forward
replication strategy for samples As previously stated in this series As we have seen in this article,
and standards and monitoring of articles, all analytical instru- expansion of the Quality process has
the procedure during routine use ments, and systems in regulated evolved and continues to date into
to ensure it continues to provide environments, need to be quali- this array of both newly defined,
reportable values that meet the fied to be “fit for intended use”. and completely new concepts, such
requirements for the measurement. In the USP, this is achieved using as Analytical Target Profile (ATP),
The proposed new chapter seeks the information provided in the “Fitness for Purpose”, “Proof of
to build a framework to link these currently official general chapter Control”, Data Integrity etc.
www.spectroscopyeurope.com SPECTROSCOPYEUROPE 43VOL. 34 NO. 1 (2022)
QUALITY MATTERS
Please be assured that any signif- (2021). https://www.ema. com/pharmacopeial-forum/
icant developments in these areas e u ro p a . e u /e n /d o c u m e nt s / pf-legacy-pdfs-archive-28-44
will be reported in future arti- scientific-guideline/draft-inter- 8. “Analytical control strategy”,
cles within Quality Matters by the national-conference-harmoni- Pharmacopeial Forum 42(5)
author(s)—so watch this space! sation-technical-requirements- (2016). https://www.uspnf.
Within the body of the article registration-pharmaceuticals_ com/pharmacopeial-forum/
are also key references to “digiti- en-1.pdf pf-legacy-pdfs-archive-28-44
sation of data”, computer systems 4. Risk Management: ISO 31000. 9. “Proposed new USP general
etc. and, of course, directly related International Organization for chapter: the analytical proce-
to these terms is the software used Standardization (ISO), Geneva, d u r e l i f e c y c l e < 1 2 2 0 > ”,
to control the systems and produce Switzerland (2018). https:// Pharmacopeial Forum 43(1)
the data. Therefore, logically, this w w w. i s o . o rg /p u b l i c a t i o n / (2017). https://www.uspnf.
fundamental component of modern PUB100426.html com/pharmacopeial-forum/
analytical systems, i.e. software and 5. “Lifecycle management of pf-legacy-pdfs-archive-28-44
data integrity, will be reviewed in analytical procedures: method 10.“ Analytical Procedure
the next article in this series. development, procedure perfor- Life Cycle”, Pharmacopeial
mance qualification, and proce- Forum 46(5) ( 2 0 2 0 ) .
References dure performance verification”, h t t p s : //o n l i n e . u s p p f. c o m /
1. I S O / I E C 1 7 0 2 5 , G e n e ra l Pharmacopeial Forum 39(5) u s p pf/d o c u m e nt / G U I D -
Requirements for the Competence (2013). https://www.uspnf. 35D7E47E-65E5-49B7-B4CC-
of Testing and Calibration com/pharmacopeial-forum/ 4D96FA230821_10101_en-US
Laboratories. International pf-legacy-pdfs-archive-28-44 11.C. Burgess, M.L.J. Weitzel,
Organization for Standardization 6. “Fitness for use: decision J.-M. Roussel, O. Quattrocchi,
(ISO), Geneva, Switzerland rules and target measurement J. Ermer, R. Slabicky, G.P.
(2017). uncertainty”, Pharmacopeial Marting and G. Vivó-Truyols,
2. I S O 3 1 0 0 0 : 2 0 1 8 , R i s k Forum 42(2) (2016). https:// “Analytical Instrument and
Management. International www.uspnf.com/pharmaco- System (AIS) qualification, to
Organization for Standardization peial-forum/pf-legacy-pdfs- support analytical procedure
(ISO), Geneva, Switzerland archive-28-44 validation over the life cycle”,
(2018). https://www.iso.org/ 7. “Analytical target probe: struc- Pharmacopeial Forum 48(1)
standard/65694.html ture and application through- (2022). https://online.usppf.
3. ICH, ICH guideline Q9 (R1) out the analytical lifecycle”, com/usppf/document/GUID-
on Quality Risk Management. Pharmacopeial Forum 42(5) 8A30D2D5-7056-460D-A7B0-
European Medicines Agency (2016). https://www.uspnf. E93446F9979B_10101_en-US
John Hammond is an experienced analytical scientist,
spectroscopist and technical marketing professional,
skilled in the development, production and marketing of
analytical systems into highly regulated and controlled
industries. A Fellow of the Royal Society of Chemistry
(FRSC), executive member of ISO/TC334 and an Expert
Advisor to the United States Pharmacopeia, General
Chapters, Chemical Analysis committee.
j.p.hammond@starna.com
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