The process of Chamber qualification is identified in CFR 21 part 211, subpart C. In Guidance for Industry Process Validation: General Principles and Practices on page 10 section C paragraph 2 states “Here, the term qualification refers to activities undertaken to demonstrate that utilities and equipment are...
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Stability Chamber Qualification in US
You can find the information of stability chamber qualification from the viewpoint of regulations (guidances), operations and issued 483s. 41+ Years Subject Matter Expert (SME) of the stability chamber management in the US Fortune 100 and 500 Pharma Company, Mr. Gary Ostermiller has shared his experience as below. Through...
Design Qualification – DQ
The Design Qualification (DQ) is the next step in the validation process of a new chamber, after the User Requirement Specification (URS). This document breaks down the high level requirements in the URS into individual detailed requirements and identifies where in the validation process the detailed requirements are confirmed...
User Requirements Specification – URS
The User Requirements Specification (URS) is the first in a series of documents in the process of bringing a stability chamber online. The URS is the documentation at a high level that lists the user’s physical requirements for the chamber. This documentation includes the chamber’s intended operation; the general...
Chamber Qualification / 483
Related FDA483/Warning Letter 6, Initial qualification and routine calibration, maintenance and cleaning of automatic, mechanical, and electronic. equipment is not performed according to a written program designed to assure proper’ performance www.fda.gov Initial setup of the unit should include a Design Qualification (DQ) to ensure that the unit is...