Reducing Microbiological Risk and Using Quality Tools in the Pharmaceutical Industry
09th January 2019 | 10:15 EST | Don Singer Manager, Steriles Microbiology, for GlaxoSmithKline R&D |BOOK FREE SEAT
Manufacturing has been paid dividends for many years through the use of quality tools such as statistical process control, quality function deployment, vendor audit management, hazard analysis critical control points (HACCP), value stream analysis, and other valuable methods. In the highly regulated industries that manufacture pharmaceuticals, foods and cosmetics, the quality control ‘scientists’ have been typically known to perform sampling and testing for determining the acceptability of finished products. During the past decade, the pharmaceutical industry has seen a significant regulator-industry aligned paradigm change, and an important leap into the formality of quality improvement using quality tools.
The paradigm of final product testing (and the myth of ‘testing quality into products’) has been challenged by both the industry and regulators. Recent industry and regulatory support of ‘risk-based’ concepts and principles are intended to produce a ‘desired state’ of industry development and production of pharmaceuticals that have a higher level of consistency in meeting purity, safety and efficacy than in prior history.
These concepts and principles were formalised for our industry in documents originating from the ICH Expert Working Groups. The concepts and principles documents1,2,3 are:
- Pharmaceutical Development ICH Q8
- Quality Risk Management ICH Q9
- Pharmaceutical Quality System ICH Q10
Risk management is not new to Quality Control Microbiology. In fact, microbiological control in the pharmaceutical industry has been following risk management concepts for over half a century.
The Microbiologist‘s role in this transformation of industry to a Quality by Design (QbD) thinking paradigm has become very crucial. The use of quality tools has increased, to help develop a better understanding of how and where to implement microbiological control of processes. Some quality tools can also be used to present information to others in an organised, pragmatic manner.
Quality by Design is the new paradigm moving us away from dependence on final product testing. QbD has some basic foundational intent: 1) To design product characteristics to meet specific objectives, 2) to design processes by measuring parameters (critical process parameters) that will develop target product attributes consistently, and 3) to gain better and fuller understanding over time of how product attributes (critical quality attributes) relate to product quality. In addition, there is an increase in confidence gained by understanding how process control relates to product quality.
The pharmaceutical industry paradigm change is occurring and industry has taken an important leap towards formality of quality improvement using quality tools. Recent industry and regulatory support of ‘risk-based’ concepts and principles are leading to a ‘desired state’ of industry development and production of pharmaceuticals that have a higher level of consistency in meeting purity, safety and efficacy.
Microbiologists’ role as active partners in the pharmaceutical environment is to help transform industry to a routine Quality by Design paradigm. With the help of quality tools and using the concepts and principles of Quality by Design, a better understanding of how and where to implement microbiological control of processes can be developed, and microbiological purity can be built into products for all patient populations.
Presented by Don Singer, Manager, Steriles Microbiology, at GlaxoSmithKline R&D
Don Singer is Manager, Steriles Microbiology, for GlaxoSmithKline R&D, a GSK Fellow, and a Fellow of the American Society for Quality (ASQ). Don has been a member of the USP Microbiology Committee of Experts since 2000. He is a former Malcolm Baldrige Award Examiner and is a Certified Specialist Microbiologist (NRCM) and Certified Pharmaceutical GMP Professional (ASQ). Don’s career spans over 40 years of research, quality control, quality assurance experience in the pharmaceutical, cosmetic and food industries. He is currently an adjunct instructor in the Biopharmaceutical Quality program at University of Maryland Baltimore County and an invited instructor to numerous global industry educational conferences and workshops.
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