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Contamination Control in Healthcare Product Manufacturing, Volume 3 (single user digital version)
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Volume 3 discusses extensive subjects related to water considerations and also includes invaluable advice regarding ventilation systems, the microbiology laboratory, mold, microaerophillics, Burholderia cepacia, a life cycle approach to cleaning validation, extensive coverage of risk management with … -
PDA Technical Report No. 67, (TR 67) Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and Cosmetics (single user digital version)
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The purpose of TR 67 is to provide guidance to the nonsterile product manufacturing industry on how to manage the microbial risks associated with manufacturing and storage as well as how to determine what isolates would be deemed an objectionable microorganism in nonsterile products.This document is … -
Risk-Based Compliance Handbook (single user digital version)
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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 needed … -
Systems Based Inspection for Pharmaceutical Manufacturers (single user digital version)
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Training of new employees in a pharmaceutical company almost always includes instilling a 'healthy fear' of inspections conducted by regulatory agencies. Most, if not all, countries in the world have governmental agencies responsible for the safety and efficacy of the medicines manufactured, sold, and … -
Cleaning and Disinfection (single user digital version)
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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 … -
Contamination Risk Assessment (single user digital version)
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Written by subject matter experts, these chapters are organized by topic and excerpted from volumes in the Contamination Control in Healthcare Manufacturing seriesContamination Control Risk Assessment by Tim Sandle. Chapter excerpted from Volume 1, Chapter 18 published May 2013. Contamination Risks … -
Validation of Analytical Methods for Biopharmaceuticals: A Guide to Risk-Based Validation and Implementation Strategies (single user digital version)
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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 … -
Particulate Matter in Injectable Drug Products (single user digital version)
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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 … -
Risk Management for Combination Products (single user digital version)
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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 … -
QbD and Process Validation - Complementary Lifecycle Approaches (single user digital version)
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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 … -
Cleaning Agents and Cleaning Chemistry (single user digital version)
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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 … -
Best Practices in Implementing Quality Agreements (single user digital version)
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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 … -
Auditing the CMO (single user digital version)
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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 … -
API Residues and Cleaning (single user digital version)
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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 … -
PDA Survey: 2013 PDA Objectionable Microorganisms for Nonsterile Pharmaceutical, Consumer Health, Medical Devices, Dietary Supplement and Cosmetic Products (single user digital version)
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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 … -
PDA Technical Series: Sterilization — Compilation of Technical Reports and Journal Articles on Pharmaceutical Sterilization (single user digital version)
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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 of Pharmaceutical Science and … -
Microbial Identification: The Keys to a Successful Program (single user digital version)
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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 (single user digital version)
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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 … -
Combination Products: Implementation of cGMP Requirements (single user digital version)
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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 … -
PDA Technical Report No. 54-3 (TR 54-3) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations:Annex 2: Case Studies in the Manufacturing of Pharmaceutical Drug Products (single user digital version)
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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 …
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