Validation of Climatic cabinet to study drugs/pharmaceutical stablility

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
#1

Hello,

I am working on preparation of IQ, OQ and PQ documents for climatic cabinets that used in testing of drugs/pharmaceuticals stability against shelf life conditions according to ICH Q1A Guidline.

Could you please provide me with IQ, OQ and PQ tempelates or validation guidline for that prupose.

thanks in advance.

Mohamed

#2

Example for PQ content:

Attachment-Non Conformance Tracking log
Performance Verification Definition
Protocol Objective
Protocol Signatories
Test Instrumentation and Calibration Certificates
Protocol Guidance Notes
Product Identification
As Found Performance Test Results
Temperature Controller Calibration
Humidity Controller Calibration
Chart Recorder Calibration
Temperature Probe Calibration
Humidity Probe Calibration
Two Points Humidity Probe Calibration
Performance Tests
Method Statement: Performance Verification
Method Statement: Probe Orientation
Non-Conformance report – Minor
Non-Conformance report – Major
Protocol Review
Protocol History
Performance Test Results

cubica:D

#3

Dear Cubica,
Mapping study [For Temp, Humidity] of chamber is missing.
Please include the same.