Cleaning validation : an exclusive publication / from the publishers of Journal of validation technology and Journal of cGMP compliance

By: Contributor(s): Material type: TextTextPublication details: Roayl Palm Beach, FL : Institute of Validation Technology, [1997?]Description: 120 p. : ill. ; 28 cmSubject(s):
Contents:
Pt.1. Features. Validation of cleaning processes for bulk pharmaceutical chemical processes / W.E. Hall -- Determining acceptance criteria for cleaning process validation / R.N. Clark -- Manual cleaning procedure design and validation / J.R. Tunner -- Epidemiology and clean design: eliminating pathways of contamination / L. Gloystein -- Pharmaceutical process design criteria for validatable CIP cleaning / D.A. Seiberling and J.M. Hyde -- How to avoid FDA 483s related to cleaning validation / E. Paoli -- Aspects to consider during cleaning process validation / A.J. DeMarinis -- Don't make cleaning validation your life's work / R.A. Nash -- Using swabs for cleaning validation: a review / D.W. Cooper -- Pt.2. Previously published papers. Ask the FDA / R.C. Coleman -- Cleaning validation programs and how to get started / C. Green -- Eight rules to live by for successful validations / H.B. Reisman -- Documentation for cleaning validation: a protocol template / M.J. Capote -- Cleaning validation doctor / C. Green -- Pt.3. Guideline. FDA guide to inspection of validation of cleaning processes.
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Holdings
Item type Current library Call number Status Date due Barcode
General General ATU Dublin Road General Shelves 615.19 (Browse shelf(Opens below)) Available 071771

Includes bibliographical references.

Pt.1. Features. Validation of cleaning processes for bulk pharmaceutical chemical processes / W.E. Hall -- Determining acceptance criteria for cleaning process validation / R.N. Clark -- Manual cleaning procedure design and validation / J.R. Tunner -- Epidemiology and clean design: eliminating pathways of contamination / L. Gloystein -- Pharmaceutical process design criteria for validatable CIP cleaning / D.A. Seiberling and J.M. Hyde -- How to avoid FDA 483s related to cleaning validation / E. Paoli -- Aspects to consider during cleaning process validation / A.J. DeMarinis -- Don't make cleaning validation your life's work / R.A. Nash -- Using swabs for cleaning validation: a review / D.W. Cooper -- Pt.2. Previously published papers. Ask the FDA / R.C. Coleman -- Cleaning validation programs and how to get started / C. Green -- Eight rules to live by for successful validations / H.B. Reisman -- Documentation for cleaning validation: a protocol template / M.J. Capote -- Cleaning validation doctor / C. Green -- Pt.3. Guideline. FDA guide to inspection of validation of cleaning processes.

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