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The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re – test period for the drug substance or product under recommended storage conditions. Hence, Pharmaceutical Stability Chamber serves as an important quality attribute for the product.
"Calibration / Validation"
Calibration:
- Temperature sensor probe calibration with tractability to ERTL
- Temperature controller calibration with tractability to ERTL
IQ, OQ, PQ and DQ documentation and protocols shall be provided with equipment.
Documentation shall be given after supply & Installation.