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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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.