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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 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 …

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 …

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 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 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 …

This monograph clearly explains the Limitation of Risk Method (LR-Method). When a systematic risk analysis is performed and sampling locations are selected and evaluated in a rational manner using this method, comprehensive monitoring will reduce the number of microbiological samples necessary and provide …

Following a discussion of the regulations to be followed in the microbiological control of water processing and distribution systems, this work focuses on practical aspects in the pharmaceutical environment and gives advice on the methodology to be used, e.g., for sampling, the selection of nutrient …

PDA's Quality Culture Metrics Pilot Report summarizes the results of 43 participating manufacturing sites in Asia, Europe and North America. Benchmarking data includes site assessment results using the PDA Quality Culture Maturity Model and Tool and is analyzed by geography, product type and business …

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 …