Building a strong quality culture in your organization is crucial to producing quality products. But how can you build a strong quality culture within your organization?

Ensuring quality culture can also help prevent recurring GMP compliance issues such as data integrity, as pointed out by Regulatory Compliance Associates’ Distinguished Fellow Susan Schniepp during the 2021 Quality Week webinar, “Past, Present, and Future of Quality Culture.”

How Do FDA Investigators Inspect for Quality Culture?

Keep in mind that the FDA and other global regulators expect to see that your organization has adopted a holistic approach to quality culture. The following are examples of how FDA investigators evaluate an organization’s quality culture taken from an “Ask the Regulators” panel at the 2021 PDA/FDA Joint Regulatory Conference.

  • Can employees at all levels of an organization explain who the products produced at a site are used for and the impact on patients? When an organization has a strong quality culture, employees at all levels are aware of how their work impacts product quality.
  • Is communication about potential quality issues timely and effective?
  • Does upper management try to prevent issues with quality by staying on top of regulatory trends or guidance? Or stay on top of industry trends that may impact manufacturing operations?
  • How transparent is a site? Are issues or problems hidden?

Leading Pharma Company Seeks to Build Quality Leaders

What are some ways organizations can enhance their quality culture? AstraZeneca has created a development pathway to build the next generation of leadership in quality. 

At the 2021 PDA Annual Meeting, AstraZeneca Product Quality Group Head Stephan Krause presented the Modern Quality Professional (MQP) Development Tool, an in-house tool created to develop and advance leaders in quality. The foundation of the MQP Tool consists of three approaches:

  1. Training in GMP basics
  2. Coaching and shadowing
  3. Repetition of core job tasks

The latter comprises 70% of the program, according to Krause, because repetition of routine tasks helps with identifying areas for improvement.

In addition to technical skills, staff participating in this program are also evaluated on soft skills. 

What Happens if I Do Not Have a Robust Quality Culture?

There can be serious consequences if an organization does not have a strong, top-down quality culture.

Susan Schniepp recounted how a contract manufacturing organization (CMO) ran into trouble when the company’s leadership promised a pizza party for staff provided that batch records were released to clients within 30 days by the end of the year. In order to achieve this goal, staff released batch records to clients even if investigations were still underway in order to meet the 30-day deadline. Sometimes investigations would be closed and then re-opened after the batch records had been sent to clients. 

If the company had implemented a strong quality culture, leadership would have avoided offering a reward that conflicted with ensuring product quality. An FDA investigator would certainly not have been happy to learn what employees were doing just to receive a pizza party.

A strong quality culture that flows from the executive level down is something that FDA (and other) investigators are looking for as they inspect your site. It is also essential for ensuring quality products enter the market.

Additional Resources

Can Quality Culture Prevent GMP Issues Such as Data Integrity?

Quality Culture Assessments and Records Request Responses

Pharma Must Develop Quality Leaders: Here is One Approach

Did you know that of the FDA 483 observations issued to human drug GMP manufacturers in the United States and the European Union this year, eight primary issues and three secondary issues involve the Quality Unit? Contact us to see how Redica can help you prepare your Quality Unit for the next inspection.

Quality Unit Observations

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