The systems used to manage calibration activities vary depending on the company, its practices, and organization. These systems may have been in place before the development and revision of the Guide and may develop over time.
The examples of documents are included here for reference purposes and to give a framework for readers to develop their own documents in line with their own systems – they are not endorsed by ISPE. The material is indicative only and intended to be neither exhaustive nor prescriptive. They may be used freely within your own organization, but they should not, however, be used for commercial purposes, and are not available for resale.
The documents form part of wider management systems and they should be considered in that context.
The documents are provided in two ways:
While every effort has been made to provide the Microsoft® Word documents in a reusable format, ISPE does not guarantee that they will appear correctly when opened in Microsoft® Word or another word processing application.
This Guide is meant to assist pharmaceutical manufacturing companies in managing GxP regulated systems. ISPE cannot ensure and does not warrant that a system managed in accordance with this Guide will be acceptable to regulatory authorities. Further, this Guide does not replace the need for hiring professional engineers or technicians.
Limitation of Liability
In no event shall ISPE or any of its affiliates, or the officers, directors, employees, members, or agents of each of them, be liable for any damages of any kind, including without limitation any special, incidental, indirect, or consequential damages, whether or not advised of the possibility of such damages, and on any theory of liability whatsoever, arising out of or in connection with the use of this information.
Clinical Labeling of Medicinal Products: EU Clinical Trial Regulation
Tuesday, 03 May 2016 18.05
Design Considerations for WFI Distillation Systems Part 2
Thursday, 28 Apr 2016 18.04
2016 Annual Meeting Honorary Chair, Joseph Jimenez, Novartis
Tuesday, 26 Apr 2016 12.04