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Clearance Sale! Original Price US$240 PDA Member, US$299 Nonmember, US$190 Government Sale prices are already displayed and will be reflected during checkoutHere, in one volume, is a unique compilation rich with vital information. Mary Griffin and Dona Reber have assembled a team of subject matter experts …

Sale - 20% off! Original Price US$210 PDA Member, US$259 Nonmember, US$170 Government Sale prices are already displayed and will be reflected during checkoutThe goal of this book is to provide the reader with a well-rounded exposure to the unique aspects and considerations for implementation of cGMP …

Intended to provide guidance for the successful evaluation, validation, and implementation of alternative and rapid microbiological methods needed by the pharmaceutical, biotechnology and medical device industries to assure product quality. This technical report was written to establish industry-wide …

Fundamental to any temperature-controlled process is the expectation that materials that are stored and shipped within a controlled environment are maintained within a defined temperature range. Typically, this temperature range is within the recommended product storage requirements derived from stability …

PDA's technical report Process Validation: A Lifecycle Approach presents timely and real world guidance for the application of a lifecycle approach to process validation. The lifecycle approach has been the focus of recent process validation guidance from major regulatory agencies and represents a significant …

This 2011 PDA benchmarking survey explores the business case for pharmaceutical quality by examining the cost of poor quality and the essential role of good quality systems in the pharmaceutical industry. The survey was open to the membership of PDA, ISPE and several other industry associations. Included …

The purpose of Technical Report No. 59, Utilization of Statistical Methods for Production Monitoring is to present relevant and easy to use Statistical Process Control Methods that are applicable to our industry. The Technical Report is the latest produced as part of PDA's Paradigm Change in Manufacturing …

**Winter Booksale: 25% OFF!**The Risk Management for Temperature-Controlled Distribution Task Force has produced a comprehensive Technical Report that will help manufacturers and distributors apply risk management to distribution practices. PDA Technical Report No. 58: Risk Management for …

Similar to the manufacturing process, an analytical method can also be considered a process. The validation strategy for analytical methods could therefore conceptually follow those of Process Validation. As such, Analytical Method Validation (AMV) can be defined as the collection and evaluation of data …

PCMOSM PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations provides detailed guidance for the application and implementation of quality risk management (QRM) principles throughout the product lifecycle. Intended to align …

Written by an authoring task force comprised of European and North American experts from biotechnology manufacturers, cleaning chemical suppliers, regulatory agencies and consulting companies, PDA Technical Report No. 49, Points to Consider for Biotechnology Cleaning Validation aligns cleaning validation …

Using alternative methodology for the detection of mycoplasma requires validation and demonstration of comparability to reference standards. A PDA Task Force of experts has developed PDA Technical Report No. 50, Alternative Methods for Mycoplasma Testing to help your analytical lab feel confident in …

This Technical Report was prepared by volunteer members of the PDA Virus Spike Preparation Task Force. Technical Report No. 47, Preparation of Virus Spikes Used for Virus Clearance Studies represents the efforts of an international task force to define the quality attributes that may be applied to virus …

**Winter Booksale: 25% OFF!** The objective of PDA Technical Report No. 53: Guidance for Industry: Stability Testing to Support Distribution of New Drug Products is to describe and justify the studies using scientific data and rationale necessary to determine an appropriate stability budget for a drug …

**Winter Booksale: 25% OFF!** This technical report describes the overall quality system for distribution of pharmaceutical products and is meant to assist manufacturers in assuring that quality, integrity, and efficacy of the product are not compromised in the distribution channels, including …

As a result of a CGMP requirement that the parenteral manufacturer confirm supplier certification on packaging components, PDA Research Committee Task Group No. 14 developed test procedures that may be helpful in establishing the identity of elastomeric closure formulations.Clearance Sale 30% Off!Original …

This Technical Report was prepared by PDA Isolation Technology Task Force Members.The report addresses essential user requirements for the application of isolator technology to a broad range of manufacturing, development and testing applications in the health care product manufacturing industry. It covers …

PDA Technical Report No. 30 (Revised 2012): Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat provides current demonstrated best practices of this sterile product release method with an emphasis on use of science-based approaches during the development of a parametric release …

This Technical Report was prepared by PDA Task Force on Container/Closure Integrity. This report reviews issues of pharmaceutical product package integrity and provides guidance for evaluating the barrier qualities of a pharmaceutical package. It supersedes the previously issued PDA Technical Information …

This Technical Report was prepared by members of the PDA Validation of Tangential Flow Filtration in Biopharmaceutical Applications Task Force. PDA Technical Report No. 15 (Revised 2009): Validation of Tangential Flow Filtration in Biopharmaceutical Applications, updates the 1992 original version …