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Pharmaceutical process validation

1993; Elsevier BV; Volume: 24; Issue: 6 Linguagem: Inglês

10.1016/0306-3623(93)90455-7

1879-0011

Ira R. Berry, Robert A. Nash,

Pesticide Residue Analysis and Safety

The regulatory basis for process validation, Bernard T. Loftus organizing for validation, J. Patrick Jeater et al sterilization validation of sterile products - fundamentals, Michael J. Akers and Neil R. Anderson validation of sterile products - recent developments, Karl Hoffman validation of solid dosage forms, Jeffrey S. Rudolph process validation and quality assurance, Carl B. Rifino prospective process validation, Allen Y. Chao et al retrospective process validation, Chester J. Trubinski validation of water systems, Ward Johnson cleaning validation, P.Y. McCormick and Leo F. Cullen equipment validation, Jacek Bak et al process validation of raw materials, Ira R. Berry analytical methods validation, Louis A. Pasteelnick computer systems validation, James E. Krueger validation of lyophilized products, Edward H. Trappler validation of inhalation aerosols, Scott Bozzone analysis of retrospective production data using quality control charts, Peter H. Cheng and John E. Dutt analysis of multivariant data, Stephen T. Horhota and Carolyn L. Aitken current concepts in process validation, John Y. Lee validation termilogy, Kenneth G. Chapman.