Production Unit Operations - Drug (Small Molecule) and Biologics

Session Type: Recorded Webinar
Knowledge Element: Production Systems
Speaker: Andy Stoker, Pharmaceutical Specialist, AMEC, UK
Duration: 60 minutes

This Webinar is temporarily unavailable as we move to a new delivery method. We expect it will be online again by mid February. In the meantime, please check out our other recorded Webinars.

Participants will see the role of production in the context of other industry operations, such as Research and Development, Marketing and Distribution. The production activities are analyzed further, to provide more detail on the production operations and factors that could affect product quality and the efficiency of manufacturing operations.

There are sections on:

• Unit Operations for the manufacture of Active Pharmaceutical Ingredients, components, excipients and dose forms of both synthetic and biological origin
• Labeling and Packaging Operations
• Critical Process Equipment and Utility System attributes
• Controls required for raw materials and packaging materials
• Facility and equipment utilization and operational efficiencies

The presentation material is supplemented with guided exercises for participants and links to additional information.

Learning Objectives:

• Describe the role of production within pharmaceutical industry operations
• Identify typical methods for manufacturing synthetic APIs, solid dose forms and biological pharmaceutical products 
• Differentiate between primary and secondary unit operations
• Compare and contrast typical features of small molecule and bio products 
• Explain why there is a requirement to label and package pharmaceuticals
• Describe some ways in which products are packaged and labeled
• Analyze some of the risks to producing compliant material and deduce some of the factors which could contribute to those risks
• Suggest some of the measures that can be taken to minimize the risk to quality
• Define what is meant by a “Critical Step” and explain its significance
• Distinguish between critical and non-critical steps
• Identify Direct Impact / Indirect Impact and No Impact Systems
• Predict how the receipt, storage and dispensing of raw materials and packaging materials could influence product quality
• Identify some ways in which the efficiency of pharmaceutical production could be improved

Who should attend:

• Those working in the industry with 2-5 years experience
• Suppliers to the industry – particularly those supplying technical services, raw materials and components
• Anyone wanting a general overview of pharmaceutical production and the factors that influence it

Speaker Biography

Andy Stoker has some 25 years experience in the pharmaceutical and related industries, designing and supporting operations for both primary and secondary manufacture. His current role is Pharmaceutical Specialist in the UK offices of AMEC, a global engineering and construction company. He is responsible for working with clients to understand their real needs and develop cost-effective and innovative ways to meet their requirements. He is currently the Design Manager for an API expansion project. Stoker has also worked as a manufacturing strategy analyst for a world-class pharmaceutical company, supporting new product introduction as well as production throughout various phases of product life cycle.

He is a member of the team revising the ISPE Baseline® Guide on Bulk Pharmaceutical Chemicals, where he is the European leader of the chapter on “Layout and Architecture.” He has recently been the co-author of several papers on various aspects of API production – two of which were short-listed for the Pharmaceutical Engineering "Article of the Year" award."

Andy graduated in chemical engineering from the University of Cambridge in 1976. His early roles included scale-up, design development, technology transfer and support to plant production for Boots Pharmaceuticals and Fisons Pharmaceuticals. He holds a PhD from the University of Edinburgh for a study of pharmaceutical technology transfer with special reference to India and Indonesia, which involved almost 12 months of field work in those countries.

What is a Recorded Webinar?

Previously held webinars are available as recorded sessions, which you can view at your convenience. Registration orders are processed within two business days, after which participants will receive an email confirmation with a link to the Recorded Webinar. After receiving the link to the Recorded Webinar, you have 15 days to view it.

What are CPIP^SM Recorded Webinars?

CPIP^SM Recorded Webinars are a group of Recorded Webinarswas developed to help individuals in preparation for the Certified Pharmaceutical Industry Professional^SM (CPIP^SM) examination.

The Certified Pharmaceutical Industry Professional^SM (CPIP^SM) credential recognizes “change agents” as the necessary ingredient to foster industry innovation and enhance drug product quality. The credential establishes a global competency standard for industry professionals, and candidates are assessed through demonstrated education, experience, and a rigorous examination. Completion of any of these seminars does not guarantee successful completion of the CPIP certification exam, and these seminars do not include every subject to the depth of what will be covered on the CPIP exam.

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