Here is a comprehensive, easy-to-use reference designed to simplify and enhance understanding of most of the current GMP expectations and how they apply to ongoing manufacturing tasks.  This guidebook will help you make high-quality, well-informed decisions that contribute to a product`s safety, identity, strength, purity, and quality; decisions in keeping with the intent and spirit of GMP.

GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry

Medical Books

James L. Vesper

Pharmacology

PDA/DHI

This text addresses the main quality control systems that should be implemented in a microbiology laboratory with a focus on current issues and inspection trends. Written by an experienced microbiologist, the book will help you produce timely, compliant results through each phase of laboratory work from development through the stability and batch release data needed after getting your product to market.

Quality Control Systems for the Microbiology Laboratory: The Key to Successful Inspections

Science & Math

Lucia Clontz

Biological Sciences

This book systematizes and updates the technical discipline of pharmaceutical microbiology. Providing valuable knowledge for the novice and expert alike, it contains the wisdom and guidance of 40 leading pharmaceutical microbiologists, engineers, and other thought leaders. Richard Prince and 36 subject matter experts collaborate to shape this comprehensive collection of timely information. This book encapsulates current knowledge in a truly wide array of microbiological applications for the reader and contains information from global experts not found elsewhere. Contents include 900 pages of valuable reference and guidance including dozens of figures, tables, charts, other illustrations, and a comprehensive index. Major sections are as follows: o Microbiology: The Scientific Dimension, o Microbiological Technology. o Classical Aseptic Processing, o Microbiological Laboratory Testing, o Quality Systems and Regulatory Compliance, o Global Perspectives.

Microbiology in Pharmaceutical Manufacturing, First Edition

Richard Prince

Environmental monitoring programs are appropriate for manufacturing of sterile products and non-sterile products. The most stringent application of these procedures is for sterile products manufactured by aseptic processing, while less stringent procedures may be appropriately employed for terminally sterilized products, and even less stringent procedures for non-sterile products.
 Volume I covers: Practical Issues in Designing and Implementing an Environmental Control Program, Compliance Issues for Environmental Monitoring, Environmental Control Systems used in Parenteral Facilities, Cleanroom Microbiology, Establishing a Disinfection Program, Practical Aspects of Cleaning, Sanitizing and Disinfecting Rooms and Surfaces, Masterplan for Microbiological Monitoring, Cleaning/Sanitization Qualification, Microbiological Risk Analysis, Method Validation, and Validation of Water Systems

Environmental Monitoring: A Comprehensive Handbook, Volume I

Moldenhauer, Jeanne

Earth Sciences

This book serves as a comprehensive overview and guide to the technology transfer process for pharmaceutical drug substance and products and the corresponding analytical methods and tests from R&D to production. Each of the contributors has extensive personal knowledge and experience in this field and each has provided practical examples to explain the critical factors involved in achieving successful and effective technology transfers. This book will benefit practitioners working in the pharmaceutical science and related industries from R&D, commercial production to project management, clinical, regulatory affairs and quality assurance.

Technology Transfer: An International Good Practice Guide for Pharmaceutical and Allied Industries

Technology

Environmental monitoring programs are appropriate for manufacturing of sterile products and non-sterile products. The most stringent application of these procedures is for sterile products manufactured by aseptic processing, while less stringent procedures may be appropriately employed for terminally sterilized products, and even less stringent procedures for non-sterile products. Volume 2 covers: Establishing Ongoing Monitoring, Surveillance and Evaluation Programs, Establishing Alert and Action Levels: The Analysis of Environmental Monitoring Data, Trending Data/Reporting Data, Environmental Monitoring Investigations, Change Control and Preventative Maintenance, Typical Procedures Required for an Environmental Control Program, What is Required Following Remodeling, Environmental Monitoring in Non-Sterile Product Manufacturing, Introduction to Rapid Microbial Methods for Environmental Monitoring, and Rapid Methods for Water Monitoring

Environmental Monitoring: A Comprehensive Handbook, Volume II

This book offers a systematic, ten-step approach, from the decision to validate to the assessment of the validation outcome, for validating configurable off-the-shelf (COTS) computer software that generates data or controls information about products and processes subject to binding regulations. COTS software validation often is a time-consuming process in which a great deal of effort is spent determining the necessary validation tasks and the content and format of the validation documents. This book provides the templates and explains how to get from start to "go live" in the most time-efficient way. It is a tool to help industry professionals effectively validate the systems they need to move their businesses forward. This book comes with CD that provides with templates.

Risk-based Software Validation: Ten Easy Steps

David Nettleton

Janet Gough

Computers & Technology

Understanding the United States Pharmacopeia and National Formulary: Demystifying the Standard Setting Process

Susan J. Schniepp

Presents Destin LeBlanc's monthly Cleaning Memos, updated and modified to improve clarity and applicability, which were originally published on his website.

Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing

Destin A. LeBlanc

This is an invaluable guide and desk reference for readers in need of guidance in the assessment and management of contamination risk.

Pharmaceutical Contamination Control: Practical Strategies for Compliance

PhD Nigel Halls

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Books by PDA/DHI