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MIcrobiology lab requirement
Documented calibration is required before using the following to measure the facility air:
Micromanometer or Differential Pressure Gauge
Micro-ohmmeter with Airflow Hood Particle Counter
Microbiological Air Sampler and
Media plates Charts for the time, temperature and pressure recording.
SOPs for each test method, for the operation and calibrations of the equipment used,
the data to be recorded, and the criteria for acceptance must be prepared and approved before beginning the performance qualification.
MICROBIOLOGY
WHO good practices for pharmaceutical microbiology laboratories
PHARMA MANUACTURING
WHO good manufacturing practices for pharmaceutical products: main principles1
SENEDLER
https://apps.who.int/iris/bitstream/handle/10665/64465/WHO_VSQ_97.02.pdf?sequence=2
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