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**Winter Booksale: 25% OFF!** This technical report complements PDA Technical Report No. 1 (Revised 2007): Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control with a focus on steam-in-place (SIP) processes. The primary objective of the task …

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 …

It has been 14 years since PDA published the original Technical Report No. 29, and cleaning validation continues to play an important role in reducing the possibility of product contamination from pharmaceutical manufacturing equipment. Cleaning validation demonstrates that the cleaning process adequately …

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 …

This chapter is taken from the book Thermal Validation in Moist Heat SterilizationThis document describes the practical application of thermal science and engineering aspects that are essential for the development and validation of a moist heat sterilization process. The primary "tools of the trade" …

This PDA technical report provides guidance on how to detect and mitigate TBA and TCA odors and taints. Well recognized in the food and beverage industries, the literature features knowledge from these industries regarding the origin of these odors and taints, analytical methods developed, and risk management …

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 …

This Technical Report was prepared by members of the PDA Quality Risk Management Task Force. The methods used to assess risk should be appropriate for the organization and the process being assessed. The purpose of this technical report is to provide an overview of a quality risk management …

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 …

PDA`s Moist Heat Sterilization Systems Task Force has developed a scientific technical report that will help you design and operate moist heat sterilizers. Advise is offered on the following areas: Setting User Requirements and Specifications Design Qualification (DQ) Equipment and Control System …

PDA Technical Report No. 51 provides a comprehensive review of an area not adequately addressed in current guidance documents: recommended specifications for BIs to be used with sporicidal gas and vapor-phase decontamination cycles together with guidance regarding their manufacture, quality control, …

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 …