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Engineering Quality by Design
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
June 4, 2009
All human endeavors come with an associated risk. Risk, which is the probability of harm occurring and its severity, can be classified in several levels. The level of potential risk dictates the actions one needs to take to address it. Designing a drug manufacturing operation so as to minimize or eliminate such risk can be achieved using a systematic approach. Good Engineering Practices (GEP) and the principles of Quality by Design(QbD) represent the current FDA thinking to achieve such objectives.
Applying QbD principles when engineering the facility and process (operation) for producing a drug product requires good scientific understanding of both the product’s characteristics and the processing approach. Understanding the potential risks associated with the proposed operation requires utilizing Subject Matter Experts (SME) and risk analysis techniques. GMP principles must also be addressed by the eventual design thus ensuring process consistency.
QbD is not a new concept when it comes to Good Manufacturing Practice (GMP) compliance in drug manufacture. The principle has existed for a long time. It is what was always referred to as building quality in the process/product and not relying on after the fact testing. QbD in engineering is a systematic scientific risk based approach to designing performance characteristics for the operation used for the manufacture of drug products, so as to consistently meet specific objectives or quality attributes.
Applying QbD while designing the operation for the manufacture of drugs is an effective way to ensure that the operation once constructed, will produce a product with the desired quality attribute and minimize the product’s potential risks to the patient. Producing a quality, efficacious and safe product consistently while minimizing the risk to the public is the ultimate goal of drug manufacturers and regulators alike.
Specific topics to be covered include:
- Defining risk and risk levels based upon FDA Guidance Documents and ICH Q9
- Potential risk areas to consider
- Potential risk areas to the public in our manufacturing operations
- Define Quality by Design and its basic principles
- How QbD principles are applied when designing a new drug manufacturing operation
- Increasing product and process understanding
- Mitigating risks to the public
- Improving process flexibility and allowing for continuous process and quality improvement
- QbD tools and how they are used
- Other advantages to using QbD principles to the design process, including reduced environmental impact and increased safety
- Questions and answers with Dr. Gamal Amer
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Engineering Quality by Design
Gamal Amer, Ph.D.
Gamal Amer, Ph. D. is Principal at Premier Compliance Services, Inc.; Management Consultants for compliance and manufacturing operations performance in the life sciences industry. He holds a Ph. D. in Chemical Engineering and has over two decades experience in the Pharmaceutical and related industries. He has held positions of increased responsibility with leading pharmaceutical, consumer product and engineering consulting firms over the years. His experience includes comprehensive process design in bulk pharmaceutical manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations.
Dr. Amer is a recognized expert in GMP compliance and validation. He has consulted for many of the leading pharmaceutical, biotechnology and medical device manufacturers. He has lectured extensively in the US, Europe, Asia and the Middle East, taught many courses, and authored many papers which were published in peer reviewed publication. He is a member of ISPE, PDA, ACS and AIChE.