Once the Pharmaceutical Quality System (PQS) (as per ICHQ10: Pharmaceutical Quality System) is implemented, it must be ensured that it continues to be effective, and for this to happen there has to be a clear commitment from senior management to a Quality Culture.
There are several ways senior management can demonstrate their commitment to the PQS and quality in general. As per PIC/s Part I, section 1.5 (pe009-15-gmp-guide-part-1-basic-requirements-medicinal.PDF):
“Senior management has the ultimate responsibility to ensure an effective Pharmaceutical Quality System is in place…”.
PIC/s Part I, section 1.5 also states:
“Senior management’s leadership and active participation in the Pharmaceutical Quality System is essential. This leadership should ensure the support and commitment of staff at all levels and sites within the organisation to the Pharmaceutical Quality System”.
Interestingly, there is no mention of “Quality culture” anywhere in this PIC/s guide. It’s then fair to ask the question: why should a pharmaceutical company then consider implementing a Quality culture?
Why should a pharmaceutical company then consider implementing a Quality culture?
“Culture”: Can be described as the ideas, customs and social behaviour of a people or society.
“Quality”: This can be described as the degree to which:
- the intrinsic properties of a pharmaceutical product,
- its manufacturing processes, and
- all supporting processes
- fulfils the pre-determined criteria (GMP compliance and specifications).
So, a Quality culture can then set expectations of the behaviour and customs of everyone in the company (including senior management) required to ultimately achieve the pre-determined criteria of the pharmaceutical product, being GMP compliance and meeting all specifications. This should in turn reduce the chance of any product defects.
For a Quality culture to be successful it must be driven by senior management. Their commitment and accountability are essential.
Where in the guidelines is a requirement for a Quality culture mentioned, if not in PIC/S Part I or II?
And if it’s not in the GMP guidelines, it is not required, or is it?
Well, the term has started appearing in some newer guidelines relating to the hot topic of Data Integrity and in a recent FDA White Paper: Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals. It is therefore likely that this term will be included in future updates of PIC/s.
The term “quality culture” is found in the PIC/S Guidance PI-041 Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments, published in July 2021, This is a guide developed for inspectors for interpretation of GMP/GDP requirements in relation to good data management and the conduct of inspections. In general, the word “culture” is used in the context of “organisational culture” several times in this document.
Section 6.3 is dedicated to the topic of “Quality culture”. It states that a quality culture “is transparent and open, one in which personnel are encouraged to freely communicate failures and mistakes, including potential data reliability issues so that corrective and preventive actions can be taken. Organisational reporting structure should permit the information flow between personnel at all levels”.
The role of senior management is also discussed in that it states that senior management is responsible for establishing and maintaining a quality culture.
This guide is in the context of ensuring data integrity, but, this would then have to be carefully integrated into the PQS.
More recently, in April 2022, FDA published a White Paper: Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals, it is stated that a key element is that a Quality culture is an environment in which those who have responsibility for oversight and control over manufacturing are taking ownership for quality and that a Quality culture is demonstrated by organizations in which the objectives drive quality.
How can Senior Management implement a Quality culture?
Below are listed some ideas of actions senior management can take to implement a Quality culture program and be ahead of simply complying with cGMP.
Focus on a Quality culture requires engagement from all areas of the organisation and should not merely be the Quality Manager’s (or quality department’s) responsibility. Sustaining a Quality culture requires ongoing commitment.
Leading a Quality Culture could include the following:
|Current reality||Assess and understand the current reality, e.g. how would you describe the company’s quality culture? Is that described anywhere?||Brainstorm the current status, including obtaining feedback from all levels of the organisation.
See Quality Management Maturity Model below
|Quality Culture Vision||Set a compelling, unifying direction and expectations about the Quality Culture (the Quality Culture vision)||What is Senior Management’s philosophy on quality?|
|Resources||Ensure adequate resources (technical and personnel) are in place to implement and monitor the effectiveness||Who’s going to champion, implement, train, receive and assess feedback, and monitor the program?|
|Document it!||Document the vision and Quality Culture program and the goals||Should be signed by all senior management members and displayed.
Include a Quality Policy statement, the metrics/KPIs to be monitored and ongoing reviews.
|Training||Provide training in the vision and expectations of the Quality Culture||Include WHY it’s needed, and WHY it is important to the organisation and its immediate team.
Define HOW it will be implemented and monitored. Get everyone engaged!
Include the importance of personal integrity, honesty and how it’s OK to make mistakes.
Integrity = Doing what is right even when no one is looking.
Ensure that it’s communicated that all individuals have specific and important roles and are responsible and accountable for ensuring product quality and patient safety.
|Commitment||Show commitment, “Walk the Talk” and be excited about it||E.g. if during a client site tour a small puddle of water is noticed on the floor outside a manufacturing room that had recently undergone cleaning - contact the supervisor immediately to organise wiping of the floor. Or if you are trained, wipe it yourself.
How do people see that quality is important to the leaders of the business?
The values, beliefs, thinking, and behaviours should be demonstrated consistently by Senior Management
|Risks||Demonstrate a risk‐reduction mindset, always referencing patient safety||Assess and rank the risks|
|Consistency||Be consistent when other factors conflict||Product quality comes first (ahead of the cost of rejection, the time required to resolve deviations etc.)|
|Feedback||Introduce feedback pathway across the organisation about risks to the Quality Culture||Demonstrates to employees that they can make a difference.
Encourage feedback e.g. whistle-blower Form used for Quality Culture risks reporting
How is the success measured – e.g. metrics/KPIs? Use visual cues/ status boards.
|Risk Assessment||Feedback topics are risk assessed, ranked and any learnings communicated||Set up a Quality Risk Register with a ranking of risks|
|Incentives||Provide incentives and rewards where the Quality Culture is demonstrated||This demonstrates that there is a focus on this and encourages engagement.|
|Monitor||Monitor progress and effectiveness regularly and take proactive action where required||Communicate status to everyone. Use the CAPA system for continuous improvement actions|
PharmOut has been involved in helping companies implement customized Quality culture programs.
If you would like more information or advice on compliance with PIC/S GMPs, feel free to contact us at one of our offices around the world and we will try to help.
If you liked this blog and want to read more on similar topics, the following blogs may also be of interest:
- Continuous Improvement – An integral part of the Pharmaceutical Quality System (PQS)
- PIC/S GMP – 3 reasons why you should care
- Why PIC/S compliance is so important
Other useful resources:
ISPE has recognised the importance of this topic with this guidance document: The Cultural Excellence Report – Six Key Dimensions, published in 2017. It identifies specific aspects of quality systems and culture and provides recommendations for tools, techniques, and processes to use.
APQ Guide: Management Responsibilities & Review (MRR), provides a quality management framework for assessing and advancing leadership systems. It provides a systematic and proactive approach to evaluating management responsibilities highlighted in ICH Q10 and more.