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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 …

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 the Joint PDA/PhRMA Sterile Bulk Pharmaceutical Chemicals Task Force. This document provides guidance relative to the validation of aseptic processing activities utilized for the production of sterile bulk pharmaceutical chemicals. It draws upon the concepts …

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 …

PDA Technical Report 14, Revised 2008, Validation of Column-Based Chromatography Processes for the Purification of Proteins was prepared by members of the PDA Validation of Column-Based Chromatography Processes for the Purification of Proteins Task Force. Since publication of the original Technical …

This Technical Report was prepared by Lubrication of Packaging Components Task Force. The purpose for this publication is to present information. This document reviews the common lubricants, the reasons for their use, methods of application and analytical measurement. Available to download Format: PDF …

This Technical Methods Bulletin was prepared by the Task Force 17.This bulletin is intended as a review of representative methods used by glass manufacturers to rapidly identify the various types of glass containers used by the parenteral drug industry. These methods may be used to assist in obtaining …

This Technical Methods Bulletin was prepared by the Task Group 14, under the chairmanship of Mr. Frank Keim, has provided a lucid, pragmatic approach to this subject, which should be of lasting and significant value to those involved with elastomeric closures. The aim of this effort is to provide a …

This Technical Methods Bulletin was prepared by the Task Group No. 12, under the chairmanship of Sol Motola, has developed generic procedures for the extraction, separation and isolation of extractables from elastomeric closures for extractable functional group characterization and/or …

This Information Bulletin was prepared by the Container Sealability Task Force. This bulletin presents information on the various aspects of container/closure integrity and offers generic physical and microbiological tests that may be used as alternatives to the USP Sterility Test in determining …

PDA Technical Report 38, Manufacturing Chromatography Systems Postapproval Changes (ChromPAC): Chemistry, Manufacturing and Controls Documentation, prepared by the PDA Manufacturing Chromatography Systems PAC Task Force. This Technical Report addresses post-approval changes to drug substance …

The first report, Sterilizing Filtration of Gases, is prepared by PDA Sterile Gas Filtration Committee. The objective of the report is to assist the reader in the selection, qualification and validation of a filter that is appropriate for the application on hand. In this report, sterilizing filtration …

The issue of Tribromoanisole (TBA) or Trichloroanisole (TCA) tainting is relatively new to the consumer healthcare and pharmaceutical industries. Since early 2010, there have been multiple drug and consumer healthcare product recalls for musty/moldy odors and lack of experience with taints in our …

This comprehensive book provides step-by-step guidance needed to develop and implement a compliant validation program based on current ANSI/AAMI/ISO standards. It includes discussion of parametric release, reduced Biological Indicators (BI) incubation, support testing and much more.Available …

This chapter is taken from the book Environmental Monitoring: A Comprehensive Handbook, Volume 3Environmental Monitoring (EM) programs for pharmaceutical manufacturers are a key part of a comprehensive quality regimen to ensue product safety and efficacy. EM is not optional. Current Good Manufacturing …

This chapter is taken from the book Environmental Monitoring: A Comprehensive Handbook, Volume 3 A literature search will reveal that laboratory proficiency testing and personnel competency testing have been integral elements of formal microbiology quality assurance programs in most microbiology testing …

This chapter is taken from the book Pharmaceutical Contamination Control: Practical Strategies for Compliance A 'caveat' has been described as both a warning or caution, and a qualification or explanation. The word is used here with both meanings to help form a list of issues to have in mind when devising …

This chapter is taken from the book Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume 2 No industry's products more intuitively illustrate the importance of product quality than those produced by pharmaceutical manufacturers. Quality managers are especially effective …

This chapter is taken from the book Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume 2 A well-accepted premise in the pharmaceutical/biopharma industry is that the most significant source of contamination when making a sterile product is people. It is a bit ironic …