TY  - BOOK
AU  - Berry,Ira R.
AU  - Nash,Robert A.
TI  - Pharmaceutical process validation
T2  - Drugs and the pharmaceutical sciences
SN  - 0824708385 (alk. paper)
U1  - 615.10685 22
PY  - 2003///]
CY  - New York
PB  - Marcel Dekker
KW  - Pharmaceutical industry
KW  - Quality control
KW  - Drugs
KW  - Standards
KW  - United States
KW  - Drug Evaluation
KW  - standards
KW  - Drug Industry
KW  - Quality Control
N1  - Includes bibliographical references and index; Preface --  Contents --  Contributors --  Introduction --  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 Systems --  Equipment and Facility Qualification --  Validation and Verification of Cleaning Processes
UR  - http://www.loc.gov/catdir/enhancements/fy0647/2003279593-d.html
UR  - http://repository.fue.edu.eg/xmlui/handle/123456789/1547
ER  -