In the therapeutic industry, the concept of “quality culture” has evolved from being a soft, intangible ideal into a measurable, essential component of good manufacturing practice (GMP) compliance. Increasingly, regulators such as the U.S. Food and Drug Administration (FDA) and international bodies like the International Society for Pharmaceutical Engineering (ISPE) are calling for manufacturers to build a culture of quality that goes beyond documentation and procedures. Instead, quality culture must be embedded at every level of an organisation, from senior leadership to operational teams on the manufacturing floor.

We are Quality Systems Now, a regulatory compliance consultancy serving therapeutic goods manufacturers, biotechnology companies, and testing laboratories. The development of a strong quality culture is not optional—it is foundational. A mature quality culture not only ensures compliance with global standards but also drives performance, integrity, and ultimately, patient safety.

This article explores the role of quality culture in the therapeutic sector, with a focus on how ISPE and FDA guidance shape industry expectations and how organisations can take meaningful steps toward improvement.

Defining Quality Culture

Quality culture refers to the collective values, beliefs, and behaviours that determine how quality is managed and prioritised within an organisation. Unlike SOPs and policies, which can be externally mandated and enforced, culture is intrinsic—it shapes how people act when no one is watching.

According to the FDA’s “Case for Quality” initiative, a robust quality culture empowers employees to identify and resolve quality issues proactively. The ISPE defines quality culture as “the environment in which quality is understood to be critical to success, and where everyone feels responsible for quality outcomes.”

In both definitions, the key idea is that quality is a shared responsibility. It is not the sole domain of the Quality Assurance (QA) department, but rather a company-wide commitment that permeates all activities, from research to release.

The FDA’s Position on Quality Culture

The FDA has increasingly emphasised the importance of quality culture in inspections and industry guidance. In its 2011 “Pharmaceutical Quality System” guidance based on ICH Q10, the agency recognises management responsibility as a key enabler of a successful quality system. Furthermore, the FDA’s “Quality Metrics” initiative, although voluntary, seeks to encourage the measurement of culture-related indicators such as Right First Time (RFT) rates, deviation frequency, and CAPA effectiveness.

The FDA’s shift from compliance-based enforcement to performance-based oversight, particularly through the “Case for Quality” program in the medical device sector, further illustrates this trend. Here, manufacturers with demonstrable quality maturity are seen as lower risk and may be subject to reduced regulatory burden.

This approach underlines the need for companies to move from a reactive compliance mindset to one that actively promotes continuous improvement and risk mitigation through cultural change.

ISPE’s Framework on Quality Culture

The ISPE has taken a proactive role in defining and promoting quality culture within the pharmaceutical and biotech industries. Its flagship publication, “Cultural Excellence Report” (2017), provides a comprehensive framework for assessing and improving organisational culture. The report outlines six quality culture dimensions:

1. Leadership and Vision – Clear communication of expectations and a visible commitment to quality from senior management.

2. Mindsets and Behaviours – Empowering staff to speak up about quality concerns without fear of reprisal.

3. Quality Assurance Integration – Integrating QA functions throughout the product lifecycle.

4. Process Capability – Ensuring processes are designed to be robust and data-driven.

5. Continuous Improvement – Encouraging reflection, learning, and adaptation at all levels.

6. Customer Focus – Understanding that the ultimate customer is the patient, and aligning work practices accordingly.

These dimensions offer a blueprint for developing quality maturity and are increasingly used by companies as internal benchmarks or in preparation for regulatory inspections.

Building a Quality Culture: Practical Steps

While the aspiration for a strong quality culture is universal, the path to achieving it requires intentionality and consistent effort. At Quality Systems Now, we support organisations in the therapeutic space by aligning culture-building strategies with GMP and ISO 13485 compliance frameworks. The following are essential elements in this process:

Leadership Commitment

Cultural change starts at the top. Senior leaders must actively demonstrate their commitment to quality through regular communication, participation in quality reviews, and investment in training and resources. Management must set the tone that quality is a strategic priority, not merely a cost centre.

Empowering Employees

Employees must feel empowered to report deviations, suggest improvements, and raise concerns without fear of retaliation. Mechanisms such as anonymous reporting systems, feedback loops, and reward schemes for quality-focused behaviour can reinforce positive practices.

Cross-Functional Collaboration

Quality should be embedded across departments—from procurement and manufacturing to IT and supply chain. Cross-functional quality councils and integrated quality planning can ensure that decisions are made with a holistic view of impact.

Data-Driven Decision Making

Reliable data on process performance, deviations, complaints, and CAPA effectiveness are essential to both measuring and shaping culture. Metrics such as batch release timelines, out-of-specification (OOS) rates, and first-pass yield should be monitored and reviewed regularly.

Training and Continuous Learning

Ongoing training is vital for embedding quality principles in day-to-day operations. Beyond regulatory requirements, training should focus on critical thinking, problem solving, and understanding the “why” behind procedures. Training should be tailored to roles and incorporate real-life scenarios relevant to the therapeutic sector.

Auditing and Feedback

Internal audits and self-assessments provide opportunities to gauge cultural maturity. Tools like the ISPE Cultural Maturity Assessment or FDA’s Quality Maturity Model can be used to evaluate behaviours and identify gaps.

Barriers to Quality Culture Development

Despite best intentions, several challenges can hinder the establishment of a quality-driven culture:

• Siloed organisational structures can result in miscommunication or inconsistent standards.

• Overreliance on documentation may obscure behavioural or systemic issues.

• Punitive approaches to error reporting can stifle transparency and discourage learning.

• Short-term pressures to meet production targets can undercut quality priorities.

Addressing these issues requires a long-term view and alignment between regulatory objectives and business goals.

The Role of Quality Culture in Inspections and Licensing

For companies regulated by the TGA or seeking entry into the Australian market, quality culture is becoming an implicit part of regulatory expectations. During inspections, auditors often assess not only documentation and systems but also the behaviours and attitudes of personnel.

The presence of a mature quality culture can enhance confidence in the organisation's ability to maintain compliance, manage change, and ensure product safety. Conversely, a poor culture can raise red flags, even when formal documentation appears adequate.

From the perspective of regulatory compliance, culture influences:

• Deviation management and root cause analysis

• CAPA effectiveness

• Product release decisions

• Supplier qualification and oversight

• Change control and risk assessments

Conclusion

In the therapeutic industry, a strong quality culture is no longer a luxury—it is a regulatory expectation and a competitive advantage. Through the lens of FDA and ISPE guidance, we see that quality culture encompasses leadership, accountability, continuous improvement, and most importantly, a shared sense of purpose in delivering safe and effective products to patients.

At Quality Systems Now, we support organisations in cultivating this culture through strategic assessments, training, and integration with regulatory frameworks. Whether your goal is to meet GMP, ISO 13485, or enter the Australian market with confidence, building and sustaining a mature quality culture is an essential step.

A culture of quality does not emerge overnight. It is the product of deliberate action, consistent reinforcement, and a shared vision across the organisation. By embedding quality into the DNA of your operations, you not only meet compliance expectations—you exceed them.