2014 Speaker Interview – Ronald Branning
We conducted an exclusive interview with Ronald Branning, VP of Quality at Gilead Sciences ahead of his appearance at the 6th Annual Biomanufacturing Summit 2014. Mr. Branning is one of the foremost leaders in biopharmaceutical quality. Find out what he had to say here.
With over 40 years of quality experience in the industry, what key takeaways have you learned from establishing quality and compliance practices across multiple manufacturing sites?
Managing product quality and compliance across multiple production sites in a multi-national corporation is a difficult proposition at best and impossible without a system-based framework. The system must be standardized globally and implemented locally – a lesson learned from my sales colleagues: sales plans are projected globally but all sales are made locally.
Worldwide regulations, the “what” of compliance, have substantially the same content, therefore global standardization of policies is an achievable goal. Successful implementation of a systematic approach hinges on the allowance for local implementation of practices and procedures, the “how” of maintaining product quality. While these local SOPs contain the essential elements of the policies they do not need to be virtual copies of each other since local variability is inevitable.
While Quality can be simply defined by the product specifications of those characteristics assessed by quality control tests, compliance is more difficult for most people to explain beyond “adherence to the regulations”. While regulations are the framework for compliance, the practical application expected in FDA’s Quality Systems inspections is evidence of methodical monitoring, assessment and control. It is anticipated by the regulators that this systematic approach spans and interlinks the entire biopharmaceutical development, production, testing, assessment, disposition and pharmacovigilance process. Simply put compliance is documentation of product quality attribute understanding and a Quality System that demonstrates process control; COMPLIANCE = DOCUMENTED CONTROL.
The de facto world standard for designing and monitoring product quality and compliance is the International Committees on Harmonization Quality Guideline 10, (ICH Q 10) – Pharmaceutical Quality System. Q10 is usually linked with Q8 (Development) and Q9 (Risk Management) which are described collectively as Quality by Design (QbD); quality designed into production to ensure product quality.
What would you identify as the key ingredients in developing a world-class quality monitoring program?
The key elements for developing a world-class quality monitoring system are
- Establishment of an ICH Q10 based Quality System including senior management oversight and BOD governance of the system.
- Identification of meaningful metrics necessary to ensure that the system maintains a state of product / process monitoring and control.
- Statistical analysis of product quality data to determine if there are issues or trends that need to be investigated, assessed and remediated.
- Escalation of significant product quality and compliance issues and risks to senior management.
- Corrective and Preventive Action (CAPA) plans to remediate significant product quality and compliance issues including risk mitigation.
How can quality teams create synergies with production teams to renew and strengthen the manufacturing organization?
Quality is everyone’s responsibility” is the universal response to this question. In my experience the most successful production operations are comprised of Quality professionals who view product quality and compliance through a manufacturing lens and of Production professionals who manufacture medicine with a product quality and compliance mindset.
A Quality System provides the framework for a company to define their practical application of the regulations to day-to-day operations through local SOPs. This common understanding of the firm’s product quality and compliance stance should also help define roles, responsibilities and accountability for effective Quality and Production Operations.
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