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While there are books on cleanrooms available, these focus almost entirely on the physical and rarely address microbiological risks. Similarly, there are various books on microbiology (even a few about pharmaceutical microbiology), yet these books rarely mention cleanrooms, or, where they do, give controlled …

The goal of Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances is to provide detailed examples of characteristic operations and case studies that demonstrate the value of implementing QRM to effectively manage risks during manufacturing of biotechnological bulk drug …

**Winter Booksale: 25% OFF!**This book is quite different from the typical prescriptive PDA/DHI "how-to" publication. Noted pharmaceutical cold-chain expert, Kevin O'Donnell, relates a series of engaging stories carefully crafted to elevate awareness, understanding, and criticality of temperature-sensitive …

This benchmarking survey was designed to solicit feedback on and industry status on the application of the principles established in the FDA Process Validation Guidance for Industry of 2011. The survey also investigated how companies are implementing the new lifecycle approach to process validation and …

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 book addresses current scientific, regulatory and technology environmental monitoring concerns for both aseptic processing and isolation …

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 checkoutEnvironmental monitoring programs are appropriate for manufacturing of sterile products and non-sterile products. The most stringent application …

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 checkoutEnvironmental monitoring programs are appropriate for manufacturing of sterile products and non-sterile products. The most stringent application …

PDA TR 66 discusses single-use systems that are in either direct or indirect contact with raw materials, intermediates, and pharmaceutical drug substances or drug products and is intended to provide the reader with critical concepts or points to consider when implementing an single use system strategy …

The application of risk management to the processes within the healthcare industry is not just good practice, but an essential must do for any competitive and compliant enterprise. Whereas the ICH Q9 guideline "Quality Risk Management" describes the fundamental concepts, additional information is …

Written by subject matter experts, these chapters are organized by topic and excerpted from volumes in the Contamination Control in Healthcare Manufacturing seriesFacility Design and Control: Personnel by Anne Marie Dixon. Chapter excerpted from Volume 1, Chapter 5 published May 2013. Fungal and Bacterial …

Written by subject matter experts, these chapters are organized by topic and excerpted from volumes in the Contamination Control in Healthcare Manufacturing seriesFacility Design and Control: Cleaning and Sanitization by Anne Marie Dixon. Chapter excerpted from Volume 1, Chapter 6 published May …

Written by subject matter experts, these chapters are organized by topic and excerpted from volumes in the Contamination Control in Healthcare Manufacturing seriesFungal and Bacterial Spores: Contamination and Disinfection by Jim Polarine, Carol Bartnett and Dan Klein. Chapter excerpted from Volume …

Written by subject matter experts, these chapters are organized by topic and excerpted from volumes in the Contamination Control in Healthcare Manufacturing seriesDesign and Sanitization of Water Systems to Prevent Contamination by Teri C. Soli. Chapter excerpted from Volume 3, Chapter 2 published June …

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 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 …