Can a Robust QMS Lead to Reduction of 483 Observations?

When a small pharma company develops a holistic, risk-based quality management system (QMS), what happens next? How will this benefit the company?

On March 30, xCellarate Managing Director and Principal Consultant, Fenton Fong presented the Redica Systems webinar, “How to Build and Implement a QMS for Small Pharma and Biotech Firms.”

Earlier summaries of this webinar covered:

• Basic GMP requirements underlying quality management systems
• How to take a risk-based approach to building a QMS using ICH Q10
• The GMP documents needed for a robust QMS

[Related: Miss the webinar? Download the full recording here, including the slide presentation.]

The conclusion looks at the state of QMS in 2020, the impact of the pandemic, and Fong’s personal thoughts on how small pharma companies can build a strong QMS.

Spinning the 483 Citation Wheel

What has been his company’s experience in 2020 when it came to remote audits of companies? In general, he finds the same areas of concern cited by FDA and other regulators in past years: lack of written procedures, lack of control, and lack of testing.

“So, what does that mean for 2021 and the vaccine rollout?” he asked. “It is going to be interesting really to see how the inspection data will look for 2021 and onwards in light of the global mad rush for vaccine manufacturing in the biggest rollout in all of human history.”

Fong expects restrictions on travel to continue to impact inspections in 2021. Yet he does not expect major changes in the types of inspection observations.

“There is still a significant percentage of the industry that approaches the quality management system largely through discrete GMP compliance procedures versus a comprehensive quality systems approach,” he said. “One major factor I believe in the cause of the inconsistency is that there is a slow adoption of QMS development by the holistic approach I described versus the traditional approach.”

[Author’s Note: Check out a case study presented during the webinar in the video clip below.]

He sees companies adopting bits and pieces of a holistic approach but lack a full understanding of the holistic approach. Further, he believes if more companies adopted a holistic approach, there would be a shift in the patterns of repeating inspection observations.

The key is making quality the company’s mission instead of relegating it to the quality department. Quality needs to be instilled as a responsibility of every individual in the organization. Successfully instilling this leads to better developed written procedures, better control, and more comprehensive testing. “This is a big factor that can lead to a reduction, I believe, in these themes of recycled citations,” Fong said.

Impact of the Pandemic on QMS

Like everything else in pharma, quality departments have been affected by the global COVID-19 pandemic. He has seen the following impacts when it comes to QMS procedures and documentation.

• General slowdown of regular quality department activities (internal/external audits, extended time for CAPA resolution, batch record reviews, etc.)
• Layoffs, staffing shortages, increased workloads with fewer people, staggered shifts, remote work
• Increased impetus towards online training and further drive to move away from paper-based QMS to e-QMS systems
• Additional work for daily health checks, additional PPE, documentation of health checks and PPE
• Visitor control policy questionnaires, employee health and hygiene, plexiglass screening, etc.
• Defining responses to incidents of positive tests, lost time, cooperation with regional health authorities
• Remote audits have found that there have been empty hand sanitizer bottles in wash-up stations and bathrooms that needed more frequent refilling than in the past
• Need to gather information and documents efficiently as possible for remote audits

Strong QMS Requires Strong Quality Culture

Fong offered his thoughts on building a culture of quality.

“It is important to have senior management buy-in and support,” he said. Not only is this important from an ICH perspective but it is also critical from a morale and motivation standpoint.

Related to this, it is also important for quality and production to work together as partners. While this relationship has evolved positively across the industry and over the past 20 years, he does continue to see it happen on occasion where there is an antagonistic or otherwise less productive relationship between the two functions.

“What you need to do is build positive relationships across different departments,” Fong said. One simple strategy he suggested is to bring a member of senior management into company-wide sessions for quality training and to have them give a few plenary words. This simple act goes a long way towards motivating staff.

It is also crucial to balance risk to product quality with the need to move business forward and to prioritize the right things in a QMS. Quality must be built into the product, it cannot be tested into the product.

He then explained that quality objectives should not be viewed as at odds with business objectives as the costs of poor quality can be substantial, even detrimental for a business.

Ultimately, the guiding principle for a strong QMS is that “GMPs tell you what to do, but they do not tell you how to do it.” Fong added, “anything that can potentially impact product efficacy and safety is important for consideration in your QMS.”

[Related: Miss the webinar? Download the full recording here, including the slide presentation.]