Moving From Quality Control To Quality Assurance

Download as pdf or txt
Download as pdf or txt
You are on page 1of 5

Reprinted from

PHARMACEUTICAL ENGINEERING
THE OFFICIAL TECHNICAL MAGAZINE OF ISPE

MARCH/APRIL 2014, VOL 34, NO 2


quality systems
©Copyright ISPE 2014
Pharmaceutical Quality Management
www.PharmaceuticalEngineering.org

Moving from Quality Control to


Quality Assurance
by Guy Wingate, PhD

This article provides ways to implement an effective quality management


system to allow manufacturers to meet their ethical and regulatory obligations.

T 
his article is based on content from and into Quality Assurance (QA).1,2 Today’s modern busi-
the presentation, “Moving from Qual- nesses are becoming more proactive and less reactive.3
ity Control to Quality Assurance” held The World Health Organization defines Quality Control
during the ISPE Proactive Compliance (QC) as “the sum of all procedures undertaken to ensure
Conference on 13-14 January 2014 by the identity and purity of a particular pharmaceutical.”3
Dr. Guy Wingate, VP and Compliance The purpose of QC is to ensure the safety and efficacy of
Officer (Global Manufacturing and Sup- a finished drug product before it is released to the public.
ply), GSK. As reflected in the theme of Supporting quality systems need to detect whether items
the conference, a collective challenge such as raw materials, components, containers, labeling and
facing the industry is to achieve proactive compliance. This packaging fail to meet pre-existing specifications. The QC
involves effective management and control of the manu- Department is responsible for conducting this work as well
facturing environment to avoid problems rather than just as testing the finished product to ensure it meets regulatory
responding to problems after they have happened. requirements. For pharmaceuticals, QC may involve analyti-
As it applies to many of us, this means assuring sustained cal procedures ranging from simple substance screenings to
higher performance (often during a period of significant complex pharmacopoeia monographs.
change) with no nasty surprises. Central to our thinking Quality control at its core is a reactive process. The pre-
must be the person at the end of our supply chain and their market checks and inspections do their best to assure phar-
trust in us to comply with regulatory requirements and
ensure the products we make are fit for purpose. In the phar- Quality Control vs. Quality Assurance
maceutical industry, the Quality Department is playing an
Quality Control Quality Assurance
increasingly pivotal role in running a sustainably profitable
business that is also committed to meeting the expectations Product Process
of the patient and the public. Executive managers, R&D,
Reactive Proactive
manufacturing, and sales and marketing all feel the pres-
sures of productivity challenges, organizational changes and Corrective tool Preventative tool
increasing regulatory requirements, but the fundamentals
Completed by experts Implemented by managers
of quality and compliance must never be compromised. The
implementation of an effective quality management system Ensures and checks Develops and defines
allows manufacturers to meet their ethical and regulatory Failure detection Failure prevention
obligations. It is good business sense to remove defects, re-
duce deviations and eliminate waste. To achieve the highest Identify and correct defects Prevents defects
level of safety, purity, and efficacy of drug products, quality Identification through Prevention with statistical and
management teams are moving beyond Quality Control (QC) inspections and peer review managerial tools

PHARMACEUTICAL ENGINEERING MARCH/APRIL 2014 1


quality systems
Pharmaceutical Quality Management

maceutical manufacturers of the standard of products being short-term goals. Success depends on total commitment
made and sold, but QC alone cannot guarantee that a high of management and staff.
quality product will be consistently produced. Substantial • Product Knowledge – quality assurance must have com-
manufacturing waste (time and materials as a result of pro- plete documented product, system, and process knowl-
cess deviations) and post-market recalls are evidence of this. edge. Product knowledge must include raw material and
A better approach is needed as the FDA acknowledge in their specific production audit, testing, and validation require-
2006 Guidance for Industry, Quality Systems Approach to ments.
Pharmaceutical Current Good Manufacturing Practice Regu- • Facility Knowledge – quality teams should include
lations stated, “Quality should be built into the product, and personnel with expertise of equipment and access to edu-
testing alone cannot be relied on to ensure product quality.”4 cational resources to stay current with regulatory updates
Quality Assurance (QA) involves taking a proactive ap- and process validation changes.
proach to ensure drug products are made in accordance with • Basic GMPs – ensure basic cGMP compliance is robust
manufacturing standards and met their pre-defined product and sustained (in place, in use and effective). Never as-
specifications. The aim is for quality and compliance to be sume basic processes like deviation management, root
achieved “right the first time” rather than depend on detect- cause analysis and Corrective and Preventive Action
ing problems. The aim is to continually improve manufac- (CAPA) look after themselves. CGMP compliance is per-
turing standards, eliminating errors along the way. Quality ishable and needs nurturing to support quality assurance.
control still has a role to play, but with effective QA and reli- • Networking – quality assurance teams should be proac-
able operational performance during the process, it becomes tive in networking with regulatory agencies and peers
a component of the pharmaceutical quality system.2 with similar product lines. Opportunities should be made
The responsibilities of quality assurance include: available for education and current trends through con-
ferences and regulatory resources.
• Products intended for public are safe, effective, and ap- • Risk Analyses and Decision Allowances – risk analyses
propriate as to dosage. should be based on good science and data. Decision
• Predetermined quality standards are upheld when choos- making authority should be backed with expert process
ing and accepting products from suppliers. analyses and the ability to alter standard operating proce-
• Labeling and packaging meets regulatory requirements as dures.6


to storage and usage.
• Recall process is standardized and prepared for defects in
post-market products. The holistic approach
• Post-market communications are available for public
concerns and questions. to quality assurance needs
The leading guidance on pharmaceutical quality manage-
to promote transparency
ment systems is ICH Q10 published in 2009 by the Inter-
national Conference on Harmonisation (ICH). This Guide
in support of performance
describes quality system management integrating Good improvement.
Manufacturing Practice (GMP), based on science- and risk-
based approaches.1 Quality assurance is a part (along with Pharmaceutical companies must ensure they do not fall
quality control) of the broader concept of quality manage- down on the basics. A good example was discussed at the
ment. Pharmaceutical quality systems need to provide the ISPE Proactive Compliance event. Management often use
necessary framework for implementing continual improve- a single metric to track the effectiveness of CAPA manage-
ment and risk management in the drug manufacturing ment. The chosen metric can have unforeseen implications
process.4 This is also consistent with the concepts of Quality if it focuses on the corrective aspect of CAPA to return a pro-
by Design (QbD).5 cess to normal operation. CAPA actually comprises two dis-
A holistic approach to quality assurance is needed. The tinct activities as the name suggests. The first aspect focuses
internal control framework needs to cover governance, sys- on investigating, understanding, and taking action to correct
tems and processes, as well as distinct activities that encour- a problem. The second aspect focuses on defining and
age a supportive mindset and organizational behavior. Key implementing action to prevent recurrence. Fundamental
aspects to consider include: to both, in order to achieve successful quality performance
improvement, is the identification of the real root cause of
• Company Awareness – quality assurance is a part of the problem being fixed and not to rely or accept cursory or
normal business, an integral part of achieving long and superficial assessments based on assumptions. A separate

2 MARCH/APRIL 2014 PHARMACEUTICAL ENGINEERING


quality systems
Pharmaceutical Quality Management

Figure 1. Calculating cost of poor quality at your site (ISPE/PDA Figure 2. Evaluating the cost of improving quality (ISPE/PDA Survey
Survey September 2011). September 2011).

metric for each aspect of CAPA is therefore recommended ting to enhanced QA by eliminating inefficient processes and
which require equal management attention. streamlining manufacturing operations.
The holistic approach to quality assurance needs to In 2012, Richard Friedman, Associate Director of FDA’s
promote transparency in support of performance improve- CDER’s Compliance Office’s Office of Product Quality, ad-
ment. Staff, wherever they work, need to feel safe in raising dressed the need for pharmaceutical companies to mod-
deviations and other concerns with their line management. ernize the control process in which products are manufac-
An open and trusting relationship must be maintained so tured and better analyze the quality risks. This direction is
that production problems are raised as they occur for rapid supported by Generic Drug User Fee Program and the FDA
resolution. A learning culture needs to replace a “mistakes- Safety and Innovation Act. Friedman endorsed the intent
are-punished” or a “someone-is-to-blame” approach to of ICH Q10 which is optimal quality through knowledge
quality issues. A Speak-Up program should be established to management, change, and innovation.7 Pharmaceutical
provide an alternative means for staff to raise concerns to an quality management teams can modernize manufacturing
internal independent group. Such programs need to make by constructing their quality system on a holistic framework
provision that enable confidential disclosures to be made. It of key elements. Governing management, system processes,
is vital to sustain trust and prevent any retaliation against and a quality culture mindset become the basis of quality
those raising problems in good faith. It is better for organi- management, and therefore, quality assurance. Within this
zations to deal promptly with issues raised than wait for a structure, elements such as QbD and QRM support each
frustrated individual to feel their only option is to become a
whistleblower.
Although companies are finding the
value in moving toward the QA para-
digm, reaching optimal quality assurance
has its challenges. Quality systems in
manufacturing sites are often hindered
by cumbersome collections of documents
requiring reactive rewrites with process
or procedural changes. Manufacturers
also face a lack of Subject Matter Experts
(SMEs) with the necessary process
and product understanding to support
leading edge practices such as Qual-
ity by Design (QbD) and Quality Risk
Management (QRM). Pharmaceutical
manufacturing companies need to lead
the manufacturing industry by commit- Figure 3. Ghost in the Machine – Culture.

PHARMACEUTICAL ENGINEERING MARCH/APRIL 2014 3


quality systems
Pharmaceutical Quality Management

• Are people satisfied and engaged?


• Do policies and procedures acknowledge how real people
work and what they are capable of?
• Do managers have personal visibility into what people are
actually doing?
• Is there a supportive organisational culture in place?

Individuals can find themselves culpable for not taking these


expectations seriously.
Management must clearly communicate what needs
to be accomplished so that everyone understands what is
expected. Part of this should include explaining what is not
tolerated in terms of standards and behavior. The same
expectations should be applied equally, including any sup-
porting disciplinary processes, to all levels of the organiza-
tion.
To achieve higher quality through QA, manufacturing
Figure 4. Significant benefits achieved through the measurement of companies, as well as suppliers and regulators must work
cost of poor quality.
together. FDA Commissioner Janet Woodcock recommends
an investment in the mutual objective of “an agile, flex-
other. This facilitates sustained and continual improvement ible pharmaceutical manufacturing sector that can reliably
benefiting both patients and business stakeholders. produce high quality medicines without extensive regulatory
Quality can be better managed when it is recognized and oversight.”10 Shared beliefs, values, attitudes, and behavior
understood that the control of variability and prevention patterns are pieces of the jigsaw that must come together.


of waste is imperative to achieve a cost effective business8 -
Figure 1. In 2011, an ISPE/PDA joint survey found that more
than half of manufacturers had not calculated or evaluated Adopting a proactive
the projected outcomes of the Cost of Poor Quality (CPQ) -
Figure 2. Ideally, we strive to keep quality, cost, and supply approach to quality
in harmony, but when we need to prioritize, it is only pos-
sible to achieve two and quality must always be preserved -
management is essential to
Figure 3. Quality management when structured with quality
assurance using cost analyses as a business driver, reaps the
achieve the step change in
cost benefits of a proactive approach - Figure 4. quality performance expected
A company must set the “tone from the top” when raising
expectations of quality by implementing a systematic quality from our industry.
management approach. To move into quality assurance and
therefore a more proactive approach to quality, senior man-
agers must first understand the specific working principles Adopting a proactive approach to quality management is
of the site including its drivers, constraints, and manufactur- essential to achieve the step change in quality performance
ing goals. Taking these points into account, management expected from our industry. The energy and motivation for
must then strategically prioritize cost targets, quality expec- quality comes from the top. Management must acknowledge
tations, and their business scope.2 the challenge of change this will involve in their organiza-
The U.S. Department of Justice has set out clear expecta- tions and stay vigilant. Everyone must play their part. A
tions for company executives senior management when it culture of quality will empower teams to continually improve
comes to cGMP compliance.9 The following reflective ques- and solve problems. We must remember that the person at
tions give an indication of what is expected from company the end of our supply chain is depending on us to provide
leaders. safe and effective medicines.

• Do we have the right people (capability and attitude – *Disclamer: the views expressed are personal opinions and
employees, contractors, suppliers)? do not necessarily represent the views of GlaxoSmithKline.
• Do people have the right incentives to see, report and fix
problems?

4 MARCH/APRIL 2014 PHARMACEUTICAL ENGINEERING


quality systems
Pharmaceutical Quality Management

References About the Author


1. Dubey, Neetu, Himanshu Gupta, R.K. Sharma, Nitin Guy Wingate, PhD is currently Vice-
Dubey, and Nidhi Dubey, “Pharmaceutical Quality President and Compliance Officer for
Manangement System: Current Concept,” Journal of Ad- Global Manufacturing and Supply at
vanced Pharmacy Education and Research, 2: 120-124, GlaxoSmithKline and has more than 20
2011. years of experience working in the phar-
2. Caldwell, Pete, Alex Sifniotis, and Edite Laka, “Qual- maceutical industry. At GSK he has held
ity Assurance in the Pharmaceutical Industry,” Tefen several roles including overall responsibility for quality for
Tribune: Life Science Issue, 2012. one of GSK’s largest manufacturing sites, responsibility for
3. World Health Organization, Medicines: Quality Control, QA technology strategy, leading a major revision to the GSK
http://www.who.int/medicines/areas/quality_safety/ corporate quality management system, and overall responsi-
quality_assurance/control/en. bility for computer compliance standards and implementa-
4. US Food and Drug Administration, Guidance for an tion. Wingate has been involved with the GAMP COP for 21
Industry: Quality Systems Approach to Pharmaceutical years in various capacities; most recently he has chaired its
cGMP Regulations, Rockville: US Department of Health governing body GAMP Council 2000-2010. He has led the
and Human Services, 2006. Task Teams producing several ISPE guidance documents,
5. Khar, Dr. Roop Krishen, “Evolution of Quality Control including GAMP® 5 and the Science and Risk-based Ap-
in Pharmaceutical Technology,” Journal of Advanced proach for the Delivery of Facilities, Systems, and Equip-
Pharmaceutical Technology and Research, 4 (4): 172, ment Guide. Wingate served on the ISPE International
2013. Board of Directors between 2008-2012. He is a Chartered
6. Huxsoll, Jean F, “Quality Assurance for Biopharmaceuti- Engineer and holds a BSc, MSc, and PhD from University of
cals,” Wiley-Interscience, 1994. Durham in computing, advanced electronics, and engineer-
7. Shanley, Agnes, “FDA’s Friedman’s Challenge to Pharma ing science respectively. He is widely published in journals
Execs: Modernize!” pharma QbD, February, 2012. and books, and regularly chairs and speaks at conferences
8. Lynn, Stephen, “Product Manufacturing and Quality: in the US and Europe. He can be contacted by email: guy.
Pharmaceutical Current Good Manufacturing Practices as.wingate@gsk.com.
(CGMPs),” US FDA, 13 October 2013. GlaxoSmithKline, C Block Main Office Harmine Rd.,
9. Maame Ewusi-Mensah Frimpong, (Deputy Assistant At- Barnard Castle, County Durham, United Kingdom DL 12
torney General for DOJ’s Consumer Protection Branch), 8DT.
Pharmaceutical Compliance Congress, 29 January 2013.
10. Woodcock, Janet, “Driving Quality and Compliance
throughout the Product Life Cycle in a Global Regulatory
Environment,” FDA/PDA Joint Conference, Keynote
Speaker, 2013, Renaissance Washington DC Hotel,
Washington, DC.

PHARMACEUTICAL ENGINEERING MARCH/APRIL 2014 5

You might also like