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PDA Technical Report No. 57 (TR 57) Analytical Method Validation and Transfer for Biotechnology Products (single user digital version)
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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 … -
Steam Sterilization Process Validation (single user digital version)
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This chapter is taken from the book Thermal Validation in Moist Heat SterilizationThe manufacture of many pharmaceutical products includes sterilization processes intended to eliminate microbial contamination. This document will review the validation requirements associated with moist heat sterilization … -
Practical Aspects of Thermal Validation for Moist Heat Sterilization (single user digital version)
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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" … -
PDA Technical Report No. 55 (TR 55) Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole Taints and Odors in the Pharmaceutical and Consumer Healthcare Industries (single user digital version)
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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 … -
PDA Technical Report No. 54 (TR 54) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations (single user digital version)
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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 … -
Technical Report No. 44, (TR 44): Quality Risk Management for Aseptic Processes
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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 … -
PDA Technical Report No. 1, Revised 2007, (TR 1) Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control (single user digital version)
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PDA's original Technical Monograph No. 1, Validation of Steam Sterilization Cycles, published in 1978, introduced the principles of steam sterilization to an entire generation of pharmaceutical scientists and engineers. The revision retains a focus on the microbiology and engineering of moist … -
Technical Report No. 45 (TR 45): Filtration of Liquids Using Cellulose-Based Depth Filters
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This Technical Report was prepared by members of the PDA Filtration of Liquids Using Cellulose-Based Depth Filters Task Force. This technical report was written to provide guidelines for the selection, validation and use of cellulose-based depth filters in pharmaceutical and biopharmaceutical … -
Technical Report No. 49 (TR 49): Points to Consider for Biotechnology Cleaning Validation
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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 … -
Technical Report No. 48 (TR 48): Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance
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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 (TR 51) Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use (single user digital version)
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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, … -
PDA Technical Report No. 50 (TR 50) Alternative Methods for Mycoplasma Testing (single user digital version)
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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 … -
Technical Report No. 47 (TR 47): Preparation of Virus Spikes Used for Virus Clearance Studies
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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 … -
PDA Technical Report No. 53 (TR 53) Guidance for Industry: Stability Testing to Support Distribution of New Drug Products (single user digital version)
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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 product. This is the first of … -
PDA Technical Report No. 52 (TR 52) Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply Chain (single user digital version)
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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 handling, storage, transportation and … -
PDA Technical Information Bulletin 2, Generic Test Procedures for Elastomeric Closures (single user digital version)
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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 … -
PDA Technical Report No. 20, (TR 20) Report on Survey of Current Industry Gowning Practices (single user digital version)
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.A survey of selected member companies of the PDA was taken by the Gowning Task Force to determine gowning practices within … -
PDA Technical Report No. 36, (TR 36) Current Practices in the Validation of Aseptic Processing - 2001 (single user digital version)
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.The validation of aseptic processing continues to be a major area of interest within the pharmaceutical industry. Five years … -
PDA Technical Report No. 35, (TR 35) A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry (single user digital version)
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.Many firms today have separate departments with different training requirements. Employees associated with the Microbiological … -
PDA Technical Report No. 34, (TR 34) Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products (single user digital version)
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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 …
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