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...
Posts Tagged with IQ
Performance Qualification (PQ)
The Performance Qualification (PQ) is the fifth and final document in the approval process for bringing a stability chamber online. This testing verifies and validates the User Requirements as listed in the URS. Depending on the verbiage in a company’s validation program, the Operational Qualification (OQ) can be the...
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...
Installation Qualification – IQ
The Installation Qualification (IQ) is the third document needed in the process of bringing a stability chamber online. The IQ is more than a turn on turn off test. It is the verification in detail of the requirements listed in the DQ. In the IQ, the requirements of the...
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...