1931879257 Preview

GAMP Good Practice Guide: Calibration Management

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering , 12/01/2001

This document has been replaced. View the most recent version.

View all product details

Historical

Track It

This item is not available for sale.

Customers Who Bought This Also Bought

 

About This Item

 

Full Description

The GAMP Good Practice Guide: Calibration Management is the first in a series of GAMP guidance on specific topics. Developed by the Calibration Management Special Interest Group (SIG) of ISPE's GAMP Forum in conjunction with representatives from the pharmaceutical industry and regulators, the Guide describes the principles of calibration and presents guidance in setting up a calibration management system, providing the structured approach required to establish formal criticality assessment, management, documentation, and corrective actions vital to regulatory compliance.

Featured Topics
- The Guide is structured to follow the life cycle of validation and is intended to cover initial calibration in addition to:

- periodic inspection, testing, and calibration
- laboratory instrumentation
- quality
- safety
- environmental issues
- regulatory requirements
 

Product Details

Published:
12/01/2001
ISBN(s):
1931879257
Number of Pages:
56
 

Document History

  1. GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management, Second Edition


    GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management, Second Edition

    • Most Recent

  2. GAMP Good Practice Guide: Calibration Management

    👀 currently
    viewing


    GAMP Good Practice Guide: Calibration Management

    • Historical Version