TY  - BOOK
AU  - Berry,Ira R.
AU  - Nash,Robert A.
TI  - Pharmaceutical process validation
T2  - Drugs and the pharmaceutical sciences
SN  - 0824708385 (alk. paper)
AV  - RS189 .P46 2003
U1  - 615.1 
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; TOC; 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 phamaceutical ingredients --
Qualification of water and air handling systems --
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 proess validation --
Harmonization GMPs, and validation; Pharmacy
N2  - The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends
UR  - http://www.loc.gov/catdir/enhancements/fy0647/2003279593-d.html
UR  - https://www.worldcat.org/title/pharmaceutical-process-validation/oclc/54001293&referer=brief_results
UR  - http://lib.ewubd.edu/ebook/4428
ER  -