Regulatory Background to Aseptic Processing (single user digital version)

Apr 2009
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PDF Single user
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This chapter is taken from the book Practical Aseptic Processing: Fill and Finish, Volume 1

Regulatory expectations for many aspects of the manufacture of healthcare products are continuously evolving, as do the technological capabilities of the manufacturers. In a global marketplace, where manufacturing may be destined for many markets, the requirements for each country will need to be met. Awareness of the current requirements, variously described in laws, regulations, directives, and guidances from regulatory bodies, and industry/standards groups, is critical to meeting these expectations. In addition, regulatory inspectors may add interpretations of what the "current" in cGMP means. Monitoring publications and presentations by regulators and industry experts may help the manufacturer determine the relative risk with any practice to be used.

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Format: Digital PDF (1 file - 135 KB)

Table of Contents

Table of Contents:

  • Introduction
  • Global Regulatory Guidance
  • US FDA
  • EU Annex 1
  • Canadian Regulation
  • Japanese Guidance
  • Other Useful References
  • Conclusions
  • About the Authors

    About the Authors

    Richard M. Johnson
    is the seventh President to serve PDA and has over 30 years of experience in pharmaceuticals and medical devices in global operations, working for Abbott Laboratories, Fort Dodge Animal Health, Alcon Laboratories and most recently as a consultant.

    Richard has been an active member at PDA, serving at various time on the Scientific Advisory Board, the Regulatory Affairs & Quality Committee, the Aseptic Processing, GMP and Glass Defects Task Forces and the Sterile Processing and Ophthalmic Interest Groups. He also has been active in PDA conferences and has published commentary articles in the PDA Journal of Pharmaceutical Science and Technology. In addition to his PDA activities, Richard has served as co-chair of the U.S. Sub-TAG to ISO/TC 198 (Aseptic Processing) and served on the Product Quality Research Institute (PQRI) Aseptic Processing Task Force.

    Gordon J Farquharson B.Sc.(Hons), C.Eng. is a Chartered Consulting Engineer with more than 30 years experience of quality and safety critical processes and facilities used by industries such as Healthcare, Life Science, Micro-electronics, etc. He is Principal Consultant with Bovis Lend Lease Technology Division`s global operation. In recent years he has focused on technologies such as isolators, barrier technology, mini-environments, critical utility systems and bio-containment.