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PDA Technical Methods Bulletin 1, Extractables from Elastomeric Closures: Analytical Procedures for Functional Group Characterization/Identification (single user digital version)
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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 … -
PDA Technical Information Bulletin 4, Aspects of Container/Closure Integrity (single user digital version)
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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 No. 21, (TR 21) Bioburden Recovery Validation (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.This Technical report by PDA`s Bioburden Recovery Validation Task Force discusses the importance of validating bioburden … -
Technical Report No. 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC): Chemistry, Manufacturing and Controls Documentation
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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 … -
Technical Report No. 40: Sterilizing Filtration of Gases
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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 … -
Risk Mitigation of Tribromoanisole (TBA)/Trichloroanisole (TCA) Taints and Odors: A Pharmaceutical Industry Benchmarking Survey (single user digital version)
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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 … -
Biological Indicators for Sterilization Processes (Hardcover)
Book
This book discusses the basic concepts necessary to the understanding of Biological Indicators and includes the history of biological validation and general principles, the kinetics of microbial inactivation and factors affecting resistance as well as guidance in understanding bacterial endospores … -
Confronting Variability: A Framework for Risk Assessment (Hardcover)
Book
Variability is more than just the ‘noise in the system.’ It represents an insidious threat to companies, ranging from the reliability of their product lines to the strength of their financial bottom-lines. The understanding of variability sources, therefore, can provide a solid framework for … -
Environmental Monitoring: A Comprehensive Handbook, Volume 4 (Hardcover)
Book
Clearance Sale - 20% off! Original Price US$335 PDA Member, US$419 Nonmember, US$290 Government Sale prices are already displayed and will be reflected during checkoutThe past decade has seen a global emphasis on environmental monitoring. Regulatory bodies worldwide have all established standards and … -
Environmental Monitoring: A Comprehensive Handbook, Volume 5 (Hardcover)
Book
Clearance Sale - 20% off! Original Price US$335 PDA Member, US$419 Nonmember, US$290 Government Sale prices are already displayed and will be reflected during checkoutThis volume edited by Jeanne Moldenhauer adds to the wealth of knowledge provided in the previous volumes by addressing several important … -
Ethylene Oxide Sterilization Validation and Routine Operations Handbook (single user digital version)
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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 … -
Pharmaceutical Microbiology Laboratories Proficiency and Competency (single user digital version)
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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 … -
Caveats of Bacterial Endotoxin Testing (single user digital version)
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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 … -
Modern Quality Systems (single user digital version)
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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 … -
Training of Aseptic Processing Personnel (single user digital version)
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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 … -
Implementing Process Analytical Technology: The Challenges and Pitfalls of Applying a Science and Risk-Based Approach in Research and Manufacturing (single user digital version)
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This chapter is taken from the book Risk-Based Compliance Handbook Readers may well be familiar with the concept of risk management but not necessarily so with the concept of Process Analytical Technology (PAT). As this book is addressing risk from a lifecycle perspective, which in turn requires a profound … -
Aseptic Process Validation and Aseptic Process Simulation Studies (single user digital version)
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This chapter is taken from the book Practical Aseptic Processing: Fill and Finish, Volume 2 This chapter will present concepts related to the validation of aseptic processing for the manufacture of sterile drug products. It will focus on those elements of aseptic processing which affect product … -
Practical Things to Improve Aseptic Process Equipment System Operation, Reduce Interventions and Reduce Product Risk (single user digital version)
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This chapter is taken from the book Practical Aseptic Processing: Fill and Finish, Volume 1 This document provides suggestions that will enable you to have systems that run well all the time and improve aseptic process equipment system operation, reduce interventions and reduce product risk. It provides … -
Regulatory Background to Aseptic Processing (single user digital version)
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This chapter is taken from the book Practical Aseptic Processing: Fill and Finish, Volume 1 Regulatory expectations for many aspects of the manufacture of healthcare products are continuously evolving, as do the technological capabilities of the manufacturers. In a global marketplace, where manufacturing … -
Validation Master Plan: The Streetwise Downtown Guide (single user digital version)
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The Validation Master Plan is used for many different purposes by different companies and by different production sites within the same company. Within the countries governed by the Pharmaceutical Inspection Cooperation Scheme (PICS), there is a current move to define what is required of a …
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