N.26 – Maintenance and Calibration of air sampler according GMP and GLP – EN 14042

TRIO

Chapter 12 “Quality Assurance” of the European Standard EN 14042 – “Workplace atmosphere – Guide for the application and use of procedures for the assessment of exposure to chemical and biological agents”.

“It is good practice to set up a Quality Assurance scheme for the maintenance and calibration of the samplers. This includes:

a) the establishment of a Standard Operating Procedure (SOP);

b) for re-usable device, a log of usage;

c) keeping a record of the traceability of the calibration;

d) retaining the raw data as required by the quality or other system;

e) using a unique and durable sampler numbering system for the re-usable devices;

f) depending on the measurement task, taking an appropriate number of field blank and replicate samples (e.g.: 10%);

g) an appropriate level of internal and external Quality Assurance”.