About the Book:

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process. 

Presenting theoretical knowledge and applied practical considerations, this title, provides an in-depth discussion of recent advances in sterilization, identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions, explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results, blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions.

Contents:

1.      Introduction

2.      Support and Utility Systems

3.      Sterilization, Sanitization, and Sterility Assurance

4.      Sterile Product Manufacturing

5.      Secondary Manufacturing

6.      Primary Manufacturing

7.      Manufacturing Related Activities

8.      Computerized Systems

9.      Laboratory Methods and Quality Assurance

10. General Topics

About the Editors:

James Agalloco is President of Agalloco & Associates, Belle Mead, New Jersey, a consulting firm to the Pharmaceutical and biotechnology industry. He was previously employed at Bristol-Myers Squibb, Pfizer, and Merck. He received his B. S. in Chemical Engineering from Pratt institute, New York, his M. S. in Chemical Engineering from Polytechnic Institute of New York, and his M. B. A. in Pharmaceutical Studies from Fairleigh Dickinson University, Teaneck, New Jersey. He is a member of USP’s Microbiology and Sterility Assurance Expert Committee for 2005-2010, and is a member of the editorial advisory boards of Pharmaceutical Technology and Pharmaceutical Manufacturing.

Frederick J. Carleton is President and Validation Consultant, Carleton Technologies Incorporated, Boynton Beach, Florida. He was formerly Manager of Scientific Affairs, Quality Control Headquarters, Pfizer Incorporated, New York. He taught Chemistry and Biochemistry at fairleigh Dickinson University, Rutherford, New Jersey. The author of over 30 publications, Mr. Carleton is a past President, Officer, and Director of the Parenteral Drug Association and was member of the Institute for Environmental Sciences, the International Society of Pharmaceutical Engineers, the American Society of Hospital Pharmacists, and the American Chemical Society. He received the B. S. degree from City Collge of new York and the M. S. degree from Purdue University, West Lafayette, Indiana, and is a graduate of the Oak Ridge Institute of Nuclear Studies.