Cover Image

Pharmaceutical process validation /

Show other versions (2)
Bibliographic Details
Other Authors: Nash, Robert A., 1930-, Wachter, Alfred H.
Format: Book
Language:English
Published: New York : Marcel Dekker, [2003]
Edition:International third edition, revised & expanded.
Series:Drugs and the pharmaceutical sciences ; 129.
Subjects:
Drug Industry > standards > United States.
Pharmaceutical Preparations.
Technology, Pharmaceutical > standards.
Drug Evaluation > standards > United States.
Quality Control.
Equipment and Supplies > standards.
Table of Contents:
  • Regulatory basis for process validation
  • Prospective process validation
  • Retrospective validation
  • Sterilization validation
  • Validation of solid dosage forms
  • Validation for medical devices
  • Validation of biotechnology processes
  • Transdermal process validation
  • Validation of lyophilization
  • Validation of inhalation aerosols
  • Process validation of pharmaceutical ingredients
  • Qualification of water and air handling
  • Equipment and facility qualification
  • Validation and verification of cleaning processes
  • Validation of analytical methods and processes
  • Computer system validation : controlling the manufacturing process
  • Integrated packaging validation
  • Analysis of retrospective production data using quality control charts
  • Statistical methods for uniformity and dissolution testing
  • Change control and SUPAC
  • Process validation and quality assurance
  • Validation in contract manufacturing
  • Terminology of nonaseptic process validation
  • Harmonization, GMPs, and validation