title: Surat pharma depot quality note - humidity limit, walk-in chamber requalification, logger gaps at goods-in, critical deviations, CAPA follow-up, self-inspection, printed copies, audit findings
doc_id: QCL-QA-NTE-44
owner: Pooja Desai
department: QA and Compliance
status: in_force
effective_date: 2026-05-04
applies_to: Surat pharma depot

SURAT PHARMA DEPOT QUALITY NOTE

This note covers the humidity limit, walk-in chamber requalification, logger
gaps at goods-in, critical deviations, CAPA follow-up, self-inspection,
printed copies and customer audit findings at the Surat depot.

HUMIDITY LIMIT IN THE CRT STORE
The humidity limit in the CRT store is 70 per cent RH. A reading above the
limit for 60 minutes is a deviation.

WALK-IN CHAMBER REQUALIFICATION
Each walk-in chamber is requalified every 24 months, and within 60 days after a
compressor is replaced.

LOGGER GAPS AT GOODS-IN
A gap of up to 20 minutes in an inbound vehicle's temperature printout may be
accepted by the goods-in clerk. A longer gap goes to the QA lead.

CRITICAL DEVIATIONS
A critical deviation is reported to the RP within 4 hours of discovery.

CAPA FOLLOW-UP
Every closed CAPA gets an effectiveness check 90 days after closure.

SELF-INSPECTION
The depot runs a self-inspection twice a year, in April and October.

PRINTED COPIES
A printed copy of a procedure is valid for 7 days from the print date.

CUSTOMER AUDIT FINDINGS
Each customer audit finding is answered within 30 working days.

Questions to the QA lead, extension 708.
