What is the validation time of stability chamber & frequency of recording of temp & humidity (time interval).
Pls suggest any reference guidline.
Qualification shall be conducted as per V model approach.
PQ test shall cover:
- Temperature and RH mapping for 72 hours.
- Door opening challenge study.
- Power failure study
- Recovery study.
Reference WHO guideline
Health Canada (Guide-0069)
Guidelines for Temperature
Control of Drug Products During
Storage and Transportation
EU European Commission Annex
15 Guide to Good Manufacturing
Practices
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