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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 …

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 …

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 …

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 …

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 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 …

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 …

This chapter is taken from the book Practical Aseptic Processing: Fill and Finish, Volume 1 Lyophilization has been used since the mid 1930s (Flosdorf et al., 1938) with the intent of preserving health care products that are not stable in a liquid ready-to-use form in the presence of water. The limited …

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 …

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 …

Dr. Michael Jahnke, Head of Microbiology at Pharma Hameln GmbH, introduces you to the subject of environmental monitoring of pharmaceutical areas. Major topics covered include: Cleanrooms including discussions of zones, classifications, assignment of production rooms; Air-handling systems; Causes of …

The second in this series of four books. Provides current, practical techniques that focus on considerations in the preparation and monitoring of aseptic manufacturing, taking into account the national and international requirements, and guidelines concerning the validation of aseptic processing. The …

Here is the guidance you need to host a compliance inspection. This book provides a common-sense approach for assessing an incoming inspection and preparing for it, regardless of who is conducting the inspection. Company and country cultures vary greatly, as do the regulations driving …

The companion to The Internal Quality Audit, this book performs the same valuable function by helping you focus on issues specific to your suppliers, contractors, and consultants. External audits help you ensure that each supplier consistently provides valuable services that enhance your …

Here is the common-sense guidance you need to perform an effective, systematic internal quality audit. As a quality professional, you are well aware of the repercussions caused by a nonconforming product entering the marketplace; customers may experience adverse effects or worse, and your company …