ABSTRACT

The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

chapter 1|6 pages

Regulatory Basis for Process Validation

ByJohn M. Dietrick, Bernard T. Loftus

chapter 2|24 pages

Prospective Process Validation and Paul Von Doehren

ByAllen Y. Chao, F. St. John Forbes, Reginald F. Johnson,

chapter 3|52 pages

Retrospective Validation

ByChester J. Trubinski

chapter 4|76 pages

Sterilization Validation

ByMichael J. Akers, Neil R. Anderson

chapter 5|32 pages

Validation of Solid Dosage Forms

ByJeffrey S. Rudolph, Robert J. Sepelyak

chapter 6|22 pages

Validation for Medical Devices

ByToshiaki Nishihata

chapter 7|24 pages

Validation of Biotechnology Processes

ByGail Sofer

chapter 8|52 pages

Transdermal Process Validation

ByCharlie Neal, Jr.

chapter 9|40 pages

Validation of Lyophilization

ByEdward H. Trappler

chapter 10|34 pages

Validation of Inhalation Aerosols

ByChristopher J. Sciarra, John J. Sciarra

chapter 11|38 pages

Process Validation of Pharmaceutical Ingredients

ByRobert A. Nash

chapter 12|42 pages

Qualification of Water and Air Handling Systems

ByKunio Kawamura

chapter 13|22 pages

Equipment and Facility Qualification

ByThomas L. Peither

chapter 14|42 pages

Validation and Verification of Cleaning Processes

ByWilliam E. Hall

chapter 15|18 pages

Validation of Analytical Methods and Processes

ByLudwig Huber

chapter 16|78 pages

Computer System Validation: Controlling the Manufacturing Process

ByTony de Claire

chapter 17|44 pages

Integrated Packaging Validation

ByMervyn J. Frederick

chapter 18|20 pages

Analysis of Retrospective Production Data Using Quality Control Charts

ByPeter H. Cheng, John E. Dutt

chapter 19|32 pages

Statistical Methods for Uniformity and Dissolution Testing

ByJames S. Bergum, Merlin L. Utter

chapter 20|50 pages

Change Control and SUPAC

ByNellie Helen Waterland, Christopher C. Kowtna

chapter 21|44 pages

Process Validation and Quality Assurance

ByCarl B. Rifino

chapter 22|12 pages

Validation in Contract Manufacturing

ByDilip M. Parikh

chapter 23|18 pages

Terminology of Nonaseptic Process Validation

ByKenneth G. Chapman

chapter 24|34 pages

Harmonization, GMPs, and Validation

ByAlfred H. Wachter

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