Pharmaceutical Outsourcing: Quality Management and Project Delivery (single user digital version)

Jan 2015
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PDF Single user
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Intended to set forth and explore the best practices for contract organizations from various perspectives: the contract organization, the contracting organization and the regulators.

There has been a significant amount of activity and growth in contract operations. Many companies are looking to contract providers for managing various aspects of the drug development process. Contract organizations have services that range from research activities to clinical trial management and oversight to manufacturing of the clinical supplies and commercial product to packaging and labeling as well as product testing. Virtual companies may have multiple contracts with multiple service providers for multiple phases of the drug development process and the drug manufacturing process. To complicate the matter, there is little guidance from regulatory authorities regarding the use of contract providers, and the relationship between a client and a contract provider is important and complex.

The editors and authors of Pharmaceutical Outsourcing: Quality Management and Project Delivery have experience with outsourcing and agreed to collaboratively publish a comprehensive, practical guide with the goal of offering sound, reasonable advice to the outsourcing community focusing mainly on contract manufacturing.

Book written in December, 2013

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Format: PDF (1 file 7.59 MB)

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents

    1. Overview of Outsourced Operations by Susan Schniepp
    2. Legal Aspects of Contract Manufacturing by Paul Ranson
    3. Points to Consider for the Outsourcing of High Value Manufacturing — A Customer's Perspective by Kevin O'Toole
    4. Best Practices in Implementing Quality Agreements by Ken Drost
    5. Management of Outsourced Operations: A Contract Provider's Perspective by Jane Rasmussen
    6. Quality Management System for Outsourced Operations by E.J. Brandreth
    7. Outsourced Services: A Virtual Company Perspective by Trevor Deeks
    8. Outsourcing Process Development by Spencer Oliver
    9. Outsourcing Analytical Methods by Susan Schniepp and Trevor Deeks
    10. CMOs for Early Phase Biologicals Production: Process and Analytical Development by Jonathan Mitschelen, John Lightholder and Rabi Prusti
    11. CMOs for Early Phase Biologicals Production: Contract Manufacturing and Control by John Conner, Rabi Prusti and Bill Minshall
    12. Contract Manufacture of a Commercial Biological Product by Ian Elvins
    13. Auditing the CMO by Thomas L. Thorpe and Jessica K. Walker
    14. Outsourced Qualification, Validation, Calibration, and Maintenance Activities by Jeanne Moldenhauer
    15. Outsourcing IT Services and Consulting: Benefits and Pitfalls by Siegfried Schmitt
    16. Tools for the Management of Outsourced Operations by Trevor Deeks

About the Authors

About the Editors

Dr Trevor Deeks has over 30 years of experience in pharmaceutical manufacturing, formulation and process development, quality assurance, quality control, process validation, and facility and equipment qualification. He is a Qualified Person and a UK registered pharmacist. He has also worked as a consultant managing a number of troubleshooting, inspection readiness, validation and development projects. He has worked extensively with contract manufacturing, contract testing and contract development organizations for most of his career and was the Quality lead for a number of outsourcing projects including initial CMO selection and auditing, technology transfer, Phase I-III manufacturing, process validation and BLA submission across a range of projects and including, synthetic APIs, biological APIs, solid dosage forms and injectable products and their associated analytical methods. He has also held a number of management positions with both large and small pharmaceutical companies, primarily in QA, formulation and process development and quality control. He currently resides in the USA and provides consulting services through his own consulting company. He has published over 30 papers in peer-reviewed journals and has written or contributed to a number of books covering subjects that include Bioprocess Validation, Pharmaceutical Microbiology, and Aseptic Processing. He has also contributed to the British Pharmaceutical Codex. He has been an active presenter at PDA, ISPE and Royal Pharmaceutical Society conferences and has sat on PDA, BSI, CEN, ISO and European Pharmacopoeia Commission expert working groups. He is a Past Chairman of the UK Parenteral Society and was Editor-in-Chief of the European Journal of Parenteral Sciences from 1996-2000.

Karen Ginsbury, with 27 years of experience in Quality Systems, GMP can compliance, Karen now runs her own boutique consultancy PCI Pharma. Karen has worked both in and with companies within the Pharma / biopharmaceutical industry as well as latterly medical device, cosmetics and nutraceutical manufacturers to set up, implement and help them improve their quality systems. Having conducted 100s of audits of outsourced operations and worked on 100s of quality agreements, Karen also often acts as a mediator between contract giver and acceptor in helping to resolve misunderstandings and controversy that arise during the course of a shared project. Karen is co-chair of PDA's Interest Group on Outsourced Activities and regularly lectures on the topic. A London trained pharmacist with an MSc in Microbiology from Birkbeck College, University of London, Karen is based in Israel where in addition to her consultancy company she also lectures to degree students of Pharmaceutical Engineering on Quality Control and Reliability and to MBa students on Quality Management.

Susan Schniepp is Vice President of Quality and Regulatory Affairs at Allergy Laboratories, Inc. She oversees the activities of the Quality Assurance, Quality Control and Regulatory Affairs operations for the company. She has had responsibilities for laboratory analysis, method validation, complaints, labeling, investigations, compendial affairs, and other quality systems during her 33 years in the industry. As an active member of PDA, Sue is on the Board of Directors and has been a member of the PDA/FDA Joint Regulatory Conference since 2001, chairing the conference in 2007 and co-chairing it from 2010 through 2013. In addition to her involvement with PDA/FDA Joint Regulatory Affairs Conference, Sue is Chair of PDA's Regulatory Affairs/Quality Advisory Board and has presented at many PDA venues. In 2007 she was the recipient of PDA's Distinguished Author Award for the book Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process, in 2008 she received PDA's Distinguished Service Award and in 2009 she was presented the PDA Gordon R. Personeus Award. Since 2007, Sue has served as a member of the editorial advisory board for Pharmaceutical Technology Magazine as well as authoring a quarterly column called "Insider Solutions". Sue was Chair of a USP Monograph Development Expert Committee from 2005-2010.