FREQUENCY OF CALIBRATION: A CRITICAL ISSUE FOR QUALITY CONTROL IN THE PHARMACEUTICAL INDUSTRY

Willians Portella, Maurício N. Frota

Abstract

A methodology which defines the frequency of calibration of measuring instruments that control key processes in the pharmaceutical industry is described. In accordance with international standards and best laboratory practices (ISO/IEC 17025), the methodology incorporates the experience of renowned laboratories of the Brazilian pharmaceutical industry. These laboratories accepted to participate in a survey to analyze the current practices and procedures regarding the choice of the periodicity of calibration. Given the uncertainty associated with the master standard as stated in the calibration certificate of the instrument to be used in the manufacturing process, the concept of maximum error assessment was introduced. In this sense, the acceptable error in the manufacturing process and the impact of non-compliance in calibration led to a general criterion for establishing the frequency of calibration.

Keywords

Industrial metrology, pharmaceutical industry, process measuring instruments, calibration management, frequency of calibration

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PWC-2006-TC11-008u.pdf

DOI

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IMEKO TC

TC11 - Measurement in Testing, Inspection and Certification

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