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The book contains many new practical tips, tools and case studies that will allow validation scientists and management to make good risk-based decisions during planning, execution and post-implementation changes for all projects. This book is centered on what "sufficient performance" and "suitable for …

This chapter is taken from the book Contamination Control in Healthcare Product Manufacturing, Volume 2 This chapter describes some of the sources of particulate matter contamination in injectable drugs and the clinical effects that can result from such contamination. It also reviews the development …

This chapter is taken from the book Combination Products: Implementation of cGMP RequirementsThis document discusses the complications related to developing combination products and gives details that help manufacturers understand risks and meet the regulatory requirements for such products. Available …

This chapter is taken from the book Quality By Design: Putting Theory Into PracticeThis subject matter expert discusses the QbD process as it applies to successful integration of this method with newer concepts such as Critical Quality Attributes (CQA), Critical Process Parameters (CPP) and design space …

This chapter is taken from the book Pharmaceutical Outsourcing: Quality Management and Project DeliveryThese experts offer an excellent description of contract manufacturing and control to those involved in early phase production including cGMP, quality systems and the pathway for Phase I, II, III and …

This chapter is taken from the book Cleaning and Cleaning Validation, Volume 1Here is a cogent, informed discussion written to help multi-product facilities meet the safety and regulatory requirements related to cleaning agents and cleaning chemistry.Available to download. Prior to purchase please view …

This chapter is taken from the book Pharmaceutical Outsourcing: Quality Management and Project DeliveryWritten by a subject matter expert, here is best-practice guidance that describes what to think about and how to implement those ideas as a company sets about creating a useful, effective Quality …

This chapter is taken from the book Pharmaceutical Outsourcing: Quality Management and Project DeliveryHere are the key elements to consider when auditing a Contract Manufacturer including the process, ways to identify crucial elements and tips for both CMO and auditor that will ensure success.Available …

This chapter is taken from the book Cleaning and Cleaning Validation, Volume 2Bill Hall discusses the differences between traditional cleaning and the cleaning requirements for API manufacturers. He includes regulatory requirements, the initial risk-assessment as well as the entire cleaning program.Available …

This benchmarking survey was designed to facilitate the development of a technical report on exclusion of objectionable microorganisms from pharmaceutical and over-the-counter drug products, medical devices and cosmetics. The purpose of this survey was to evaluate how different companies and industries …

**Winter Booksale: 25% OFF!** Over the years, PDA expert task forces have developed several technical reports on moist and dry heat sterilization processes. In addition, experts in the PDA community of published several articles on these topics and alternative sterilization methods in the PDA Journal …

Clearance Sale! Original Price US$240 PDA Member, US$299 Nonmember, US$190 Government Sale prices are already displayed and will be reflected during checkoutHere, in one volume, is a unique compilation rich with vital information. Mary Griffin and Dona Reber have assembled a team of subject matter experts …

Contamination Control in Healthcare Product Manufacturing, Volume 1, edited by Russell E. Madsen and Jeanne Moldenhauer, is primarily focused on microbiological contamination and the methods used to monitor and control it, a secondary focus looks at chemical contamination that may result from the use …

Sale - 20% off! Original Price US$210 PDA Member, US$259 Nonmember, US$170 Government Sale prices are already displayed and will be reflected during checkoutThe goal of this book is to provide the reader with a well-rounded exposure to the unique aspects and considerations for implementation of cGMP …

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 …

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 …

Fundamental to any temperature-controlled process is the expectation that materials that are stored and shipped within a controlled environment are maintained within a defined temperature range. Typically, this temperature range is within the recommended product storage requirements derived from stability …

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 …

**Winter Booksale: 25% OFF!** 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 …

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 …