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Pharmaceutical Outsourcing - Quality Management and Project Delivery
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PDA/DHI Publications

Pharmaceutical Outsourcing
€ 210.00
€ 224.70
  7% VAT included
Quality Management and Project Delivery
Edition: December 2013
516 Pages
ISBN: 1-933722-75-4
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 contract provider needs to be as knowledgeable and up-to-date on the application and interpretation of the regulations as its clients. It could be argued that reputable service providers have some of the most robust and compliant systems because of the frequency that clients and regulatory agencies — both domestic and foreign — audit them. Although time consuming, these audits allow contract providers to benchmark against best practices and the cumulative knowledge of the auditors. Service providers are acutely aware of the concerns of their sponsors because they are documented through audit observations, but it is not often that the complaints of the service providers are voiced.

Table of Contents:

1. Overview of Outsourced Operations
2. Legal Aspects of Contract Manufacturing
3. Points to Consider for the Outsourcing of High Value Manufacturing — A Customer's Perspective
4. Best Practices in Implementing Quality Agreements
5.Management of Outsourced Operations: A Contract Provider's Perspective
6. Quality Management System for Outsourced Operations
7. Outsourced Services: A Virtual Company Perspective
8. Outsourcing Process Development
9. Outsourcing Analytical Methods
10. CMOs for Early Phase Biologicals Production: Process and Analytical Development
11. CMOs for Early Phase Biologicals Production: Contract Manufacturing and Control
12. Contract Manufacture of a Commercial Biological Product
13. Auditing the CMO
14. Outsourced Qualification, Validation, Calibration, and Maintenance Activities
15. Outsourcing IT Services and Consulting: Benefits and Pitfalls
16. Tools for the Management of Outsourced Operations
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.
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