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

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

Science & Math

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

This unique book is a collection of interdependent chapters that are part lab manual, part essay, part historical context, part consultant and part plain sage advice that provide a practical and compliant approach to the execution and use of BET. Full of sensible technological and compliance advice that comes from the contributors` collective experience of over 200 years with BET, the book explains how standard compliance and control measures apply to this seemingly hybrid technology. It offers advice on setting appropriate process action and alert limits, controlling variability, efficient and value-added test methodology, setting limits for non-compendial materials and applying medical device testing strategies to screening of testing accessories and much more. Lab managers and analysts will find this book indispensable as they view their current processes with a goal of continuous improvement.

The Bacterial Endotoxins Test: A Practical Guide

Reference

Pharmaceutical Outsourcing: Quality Management and Project Delivery (2013-01-01)

This book is a practical guide for the control of visible defects and contamination in pharmaceutical products. It is intended for the product inspectors and lab support personnel, as well as those who use inspection results or are responsible for inspection operations. Meant to familiarize and educate seasoned inspectors with the principles of microscopy and seasoned microscopists with the elements of visual inspection, this book describes ways to find visible defects and what to do with them once found. Those in management also play an essential role in the product life-cycle and have responsibility for maintaining control of the overall process and for driving continuous improvement

Visual Inspection and Particulate Control

D. Scott Aldrich

Roy T. Cherris

John G. Shabushnig

This new book provides a truly global perspective on data integrity and the solutions available to address this serious issue. It includes two main sections: the regulatory and historic background of data integrity, and practical advice on how to prevent or rectify data integrity breaches. Each chapter is written by renowned, highly experience subject matter experts in the fields of compliance and data integrity, and includes a "how to" section with practical, implementable advice. Content is up to date with the latest regulations and guidances, making this the most relevant reference source of its kind. Useful checklists and aide memoirs can be customized by the discerning reader. This book should be equally useful for the quality unit professional, operations manager, validation experts and regulators. The modular structure allows readers to pick chapters of special interest without having to reach the chapters in order. However, given the usefulness and universal application the "nuggets of wisdom" and advice provided, it is anticipated that readers will want to read the publication in its entirety.

Assuring Data Integrity for Life Sciences

Siegfried Schmitt

Avoidance of hazards and assessment of risk have long been part of the manufacture of pharmaceuticals and healthcare products. A high quality drug product must be free from contamination and reliably deliver the intended therapeutic dose as stated on the label and to achieve this manufactures must always be mindful of risk. Tim Sandle's newest book incorporates regulatory perspectives, scientific methods and practical examples to describe approaches to problem solving when assessing, managing and reviewing risk. The book is divided into four sections that present a formal approach to risk. The first section provides a look at risk assessments and hazards, exploring the origins, looking at key concepts and philosophies and assessing the regulatory perspective. An overview of available tools for risk assessment and problem solving leads into specific 'soft skills' that can help to run an effective meeting, oversee a project and report root cause analysis and risk outcomes. The book concludes with an extensive set of case studies to show real-world applications of the tools and techniques presented. The wide range of topics presented throughout the four sections includes risk considerations for aging pharmaceutical facilities, application of quality risk management to cleanroom design and process incident investigation.

Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studies

Tim Sandle

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