دانلود کتاب میکروبیولوژی دارویی: بهترین روش ها، اعتبارسنجی، کیفیت
Pharmaceutical Microbiology: Best Practices, Validation, Quality Assurance 1st Edition

All-in-one guide to monitoring and maintaining microbiological safety in the manufacturing of pharmaceuticals, diagnostics, and cosmetics

Addressing the full spectrum of microbiological quality control and quality assurance in pharmaceutical production, Pharmaceutical Microbiology covers methods and technologies required by regulatory authorities throughout the world, with all methods and protocols rated in terms of their compliance with current (2023) EU legislation.

Written by the former head of biological quality assurance for one of Europe’s biggest pharmaceutical and diagnostics companies, Pharmaceutical Microbiology covers sample topics including:

• General conditions for the operation of microbiological laboratories, calibration and qualification of devices, and type culture maintenance
• Industrial hygiene, ambient monitoring, quality control, process validation, microbiological water examination, and rapid microbiological methods
• Automation in the microbiology laboratory, quality assurance, identification of microorganisms, cleaning, sterilization, decontamination, and disposal, and contract testing
• Pharmacopoeial and non-pharmacopoeial methods for the identification and quantification of microorganisms, including cell culture and selected animal tests

Pharmaceutical Microbiology is an essential practice-oriented all-in-one reference for engineers, researchers, and professionals involved in setting up and running a microbiological quality control unit in the pharmaceuticals, diagnostics, and cosmetics industries.

Contents

۱ Introduction to Microbiology
۲ General Conditions for the Operation of Microbiological Laboratories
۳ Calibration and Qualification of the Devices
۴ Stock Collection
۵ Industrial Hygiene
۶ Environmental Monitoring
۷ Quality Control
۸ Process Validations
۹ Microbiological Examination of Water
۱۰ Rapid Microbiological Methods
۱۱ Automation in the Microbiology Laboratory
۱۲ Quality Assurance
۱۳ Microorganism Identification
۱۴ Cleaning, Sterilization, Decontamination, and Disposal
۱۵ Contract Testing (Outsourcing)
۱۶ Microbiological Networks
۱۷ Addresses