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PDA Journal of Pharmaceutical Science & Technology TECH REPORT #33

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PDA TECH REPORT #33 Evaluation, Validation and Implementation of New Microbiological Testing Methods

عام:

2000

اللغة:

english

ملف:

PDF, 127 KB

IPFS:

,

english, 2000

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Nigel Halls — Achieving Sterility in Medical and Pharmaceutical Products (Drugs and the Pharmaceutical Sciences)

Michael J. Akers, Dana Morton Guazzo — Parenteral quality control: sterility, pyrogen, particulate, and package integrity testing

Philip A. Geis — Cosmetic Microbiology: A Practical Approach

Bhattacharya J. — Generation of pharmaceutical water

Denyer S. P. (ed.), Baird R. M. (ed.) — Guide to Microbiological Control in Pharmaceuticals and Medical Devices

— Handbook of Pharmaceutical Manufacturing Formulations Sterile Products

U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Office of Regulatory affairs (ORA) — Guidance for Industry Sterile Drug Products

Christopher M. Riley and Thomas W. Rosanske (Eds.) — Development and Validation of Analytical Methods

Author Unknown — Making Safe Food: a Management Guide for Microbiological Quality

Christopher M. Riley; Thomas W. Rosanske; George L. Reid — Specification of Drug Substances and Products: Development and Validation of Analytical Methods

Tim Sandle — Biocontamination Control for Pharmaceuticals and Healthcare

R Baird; N Hodges — Handbook of Microbiological Quality Control Pharmaceuticals

Akers, Michael K. — Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing

Groves, Michael J(Editor) — Aseptic Pharmaceutical Manufacturing II: Applications for the 1990s

Mossel, David A. A — Essentials of the Microbiology of Foods: a Textbook for Advanced Studies

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Baird, Rosamund M.; Bloomfield, Sally F — Microbial quality assurance in cosmetics, toiletries and non-sterile pharmaceuticals

Stephen P. Denyer, Rosamund M. Baird — Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition

Moldenhauer, Jeanne — Disinfection and decontamination: a practical handbook

S. Ensor David, Marie Dixon Anne — Environmental Monitoring for Cleanrooms and Controlled Environments

Luis Jimenez — Microbial Contamination Control in the Pharmaceutical Industry

Nigel Halls — Achieving Sterility in Medical and Pharmaceutical Products

Geis Phil — Cosmetic Microbiology: A Practical Approach

McMeekin — Detecting Pathogens in Food

Nigel Halls — Microbiological Contamination Control in Pharmaceutical Clean Rooms

Gall, Lorraine S.; Curby, William A — Instrumented systems for microbiological analysis of body fluids

P. Agalloco James, Frederick J. Carleton — Validation of Pharmaceutical Processes

Donald S. Orth (ed.), Jon J. Kabara (ed.), Stephen P. Denyer (ed.), S. K. Tan (ed.) — Cosmetic and Drug Microbiology

Kim Huynh-Ba — Analytical Testing for the Pharmaceutical GMP Laboratory

Davani, Behnam — Pharmaceutical analysis for small molecules

Behnam Davani — Pharmaceutical Analysis for Small Molecules

Sandeep Nema, John D. Ludwig — Pharmaceutical Dosage Forms: Vol. 2 - Parenteral Medications: Facility Design, Sterilization and Processing

Syed Imtiaz Haider; Erfan Syed Asif — Quality control training manual : comprehensive training guide for API, finished pharmaceutical and biotechnologies laboratories

D. A. A. Mossel, C. M. L. Marengo (auth.), P. D. Patel (eds.) — Rapid Analysis Techniques in Food Microbiology

D. A. A. Mossel, C. M. L. Marengo (auth.), P. D. Patel (eds.) — Rapid Analysis Techniques in Food Microbiology

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