Year-End Special – 30% Off Select Guidance Documents!
What you need to know and how to apply it! Use promo code 2015YearEnd on or before 15 January 2016 during check out to claim your special discount on the bound versions of these ISPE Guidance Documents:
Baseline® Guide: Active Pharmaceutical Ingredients (Second Edition)
This revised guide builds on the principles of ISPE’s Baseline® Guide Volume 1. Key topics include: API characterization, critical process steps, potential contamination, Good Engineering Practice, critical unit operation, intended patent use, Process Analytical Technologies, and more.
Baseline® Guide: Sterile Product Manufacturing Facilities (Second Edition)
This baseline guide is a complete revision of the original version, and contains recommendations to help facilitate compliance with the latest FDA and EMA guidance. It incorporates a comprehensive tabulation, explanation, and comparison of the cleanliness designations found in FDA, EMA, and ISO guidance documents.
GAMP® Good Practice Guide: IT Infrastructure Control and Compliance
When GxP applications are dependent upon them, IT Infrastructure failures can cause significant problems. This GAMP® Good Practice Guide helps you avoid these potential problems by teaching how to best maintain a state of control and regulatory compliance in your IT Infrastructure.
Introductory Clinical Trial Materials (CTM) Training Guide (Second Edition)
Designed to familiarize new clinical trial materials professionals with the terms and related information they need for success, this training guide focuses on clinical trial material supply units operating under the rules of the USA FDA.
Comprehensive Guide to Clinical Materials (A Handbook for Training CM Professionals)
A valuable tool for the development of in-house training sessions for advanced training, this handbook builds on the topics covered in the Introductory US Clinical Trial Materials Training Guide. It may be used in a classroom setting, and then by attendees to gain more in depth knowledge and as a reference source for future use.
Investigational Materials Sample Retention Guide (Second Edition)
This is a supplement to the Introductory US Clinical Trial Materials Training Guide, assisting users in determining quantity and retention time for sample products.
GAMP® is a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry and a registered trademark of ISPE.