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Book ThumbnailCombination Products: Implementation of cGMP Requirements (single user digital version)

The goal of this book is to provide the reader with a well-rounded exposure to the unique aspects and considerations for implementation of cGMP in a combination product environment and also includes information from leaders in the industry regarding the unique requirements for several common combination products situations.


Edited by: Lisa Hornback

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Book ThumbnailPDA Technical Report 1, Revised 2007, (TR 1) Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control (single user digital version)
This technical report was prepared by the task force that composed of 42 European and North American industry and regulatory professionals to ensure the methods, terminology and practices of sterilization science presented reflect sound science that should be able to be used globally.

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Book ThumbnailPDA Technical Report 48 (TR 48) Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance (single user digital version)
This technical report focuses on the design and operation of moist heat sterilizers, from the development of User Requirements Specifications (URS) through equipment qualification (Installation Qualification (IQ) / Operational Qualification (OQ)) and culminating with ongoing maintenance requirements.

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Book ThumbnailRisk-Based Compliance Handbook (single user digital version)
This publication puts into context the various risk assessment methodologies with the business needs at the various stages of the life cycle. The emphasis is on implementing and achieving competitive compliance through the application of risk management.
by: Siegfried Schmitt