GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management (2nd Edition) - Attachments

Print this page         

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:

  • Native format file (Microsoft® Word or Excel)
  • Adobe® Acrobat® PDF file

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.

Download the Attachments

Download Attachments Now! .ZIP file, 8 MB

The download contains these files:

  • Attachment 1: Example Calibration Master List
  • Attachment 2: Example Declaration of Decontamination Status
  • Attachment 3: Example Non-Conformance Report (2 Versions)
  • Attachment 4: Example Calibration Certificate – Type 1
  • Attachment 5: Example Calibration Certificate – Type 2
  • Attachment 6: Example Loop Calibration Certificate
  • Attachment 7: Example Standard Operating Procedure: Calibration by Work Order
  • Attachment 8: Example Calibration Report Standard Operating Procedure
  • Attachment 9: Example Calibration Work Instruction Standard Operating Procedure
  • Attachment 10: Decommissioning Checklist
  • Attachment 11: Audit Checklist
  • Attachment 12: Analytical Equipment Calibration SOP
  • Attachment 13: Analytical Equipment Calibration Certificate
  • Attachment 14: NCR/CAPA SOP
  • Attachment 15: Uncertainty Opt Out Worksheet
  • Attachment 16: Uncertainty CML Worksheet
  • Attachment 17: Measurement Uncertainty Calculation and Application – Global Engineering Standard
  • Attachment 18: Balances and Weigh Scales
  • Attachment 19: Calibration of Scales and Balance Procedure
  • Attachment 20: Analytical Instrument and Laboratory Equipment Qualification Process
  • Attachment 21: Analytical Instrument Verification Process
  • Attachment 22: Postal Audit Document
  • Attachment 23: Criticality Assessment

Disclaimer:
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.

 

Last Update: 02 December 2011

My ISPE

  • Click to go to My Communities of Practice
  • Click to go to My Affiliate or Chapter
  • Click to go to My Profile
Click to go to the Member Gift