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Validation of Pharmaceutical Processes (Hardcover, 3rd edition)
Loot Price: R5,119
Discovery Miles 51 190
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Validation of Pharmaceutical Processes (Hardcover, 3rd edition)
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Completely revised and updated to reflect the significant advances
in pharmaceutical production and regulatory expectations, this
third edition of Validation of Pharmaceutical Processes examines
and blueprints every step of the validation process needed to
remain compliant and competitive. The many chapters added to the
prior compilation examine validation and six sigma system design;
the preparation of aseptic and non-aseptic pharmaceutical products;
active pharmaceutical ingredient and biotechnology processes,
computerized systems; qualification and cleaning of equipment;
analytical methods, calibration and certification. As the
industry's leading source for validation of sterile pharmaceutical
processes for more than 10 years, this greatly expanded is a
comprehensive analysis of all of the fundamental elements of this
arena with practical solutions for every pharmaceutical and
bio-pharmaceutical production process. Presenting theoretical
knowledge and applied practical considerations, this title
-provides an in-depth discussion of recent advances in
sterilization -identifies obstacles that may be encountered at any
stage of the validation program, and suggests the newest and most
advanced solutions -explores distinctive and specific process
steps, and identifies critical process control points to reach
acceptable results -blends the use of theoretical knowledge with
recent technological advancements to achieve applied practical
solutions
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