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PDA Technical Report No. 54-3 (TR 54-3) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations:Annex 2: Case Studies in the Manufacturing of Pharmaceutical Drug Products (single user digital version)
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Provides specific case study examples of how to apply quality risk management to the manufacturing of pharmaceutical drug products. These case studies were chosen by the technical report team, of this supplemental annex to PDA Technical Report No. 54, Implementation of Quality Risk Management for Pharmaceutical … -
PDA Technical Report No. 33, Revised 2013 (TR 33) Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods (single user digital version)
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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 … -
PDA Technical Report No. 63 (TR 63) Quality Requirements for the Extemporaneous Preparation of Clinical Trial Materials (single user digital version)
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A recent benchmarking exercise conducted by the PDA Quality Requirements for the Extemporaneous Preparation of Clinical Trial Materials Technical Report Team indicates that extemporaneous preparation (EP) techniques are widely used to prepare a variety of formulations for a variety of dosage forms for … -
PDA Technical Report No. 3, Revised 2013 (TR 3) Validation of Dry Heat Processes Used for Depyrogenation and Sterilization (single user digital version)
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PDA has revised Technical Report No. 3, originally issued in 1981. The revision offers a modern, scientific approach to dry-heat depyrogenation and sterilization processes and includes recommendations for use by industry and regulators. References to appropriate and current scientific publications, international … -
PDA Technical Report No. 62 (TR 62) Recommended Practices for Manual Aseptic Processes (single user digital version)
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The purpose of this technical report is to outline methods and approaches for control and evaluation of aseptic processing operations for drug products/medicinal products which use all or partially manual procedures. This technical report has value for hospital and formulation pharmacies where manual … -
PDA Technical Report No. 54-2(TR 54-2) Implementation of Quality Risk Management for Pharmaceutical & Biotechnology Manufacturing Operation:Annex 1: Case Study Examples for Quality Risk Management in Packaging & Labeling (single user digital version)
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The first Annex to Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations provides specific case studies on how to apply quality risk management (QRM) to pharmaceutical manufacturing, specifically packaging and labeling … -
PDA Technical Report No. 61 (TR 61) Steam In Place (single user digital version)
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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 force responsible for this technical … -
PDA Technical Report No. 60 (TR 60) Process Validation: A Lifecycle Approach (single user digital version)
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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 … -
PDA Technical Report No. 29, Revised 2012 (TR 29) Points to Consider for Cleaning Validation (single user digital version)
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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 … -
PDA Survey: Business Case for Pharmaceutical Quality (single user digital version)
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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 … -
PDA Technical Report No. 59 (TR 59) Utilization of Statistical Methods for Production Monitoring (single user digital version)
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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 … -
PDA Technical Report No. 58 (TR 58) Risk Management for Temperature-Controlled Distribution (single user digital version)
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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 Temperature-Controlled Distribution is meant … -
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 … -
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. 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 …
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