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...
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...
BIOCOM CRO Best Practice Series
We are very pleased and honored to announce that we will be giving a presentation titled “Asset Management Best Practices” at BIOCOM CRO Event on September 22. http://biocomcro.org/events/ Our speaker and stability storage process consultant, Gary Ostermiller is an experienced stability professional with extensive experience in pharmaceutical stability...
Equipment Outages Documentation
In the rush following the discovery of a malfunctioning chamber, some of the most important information may be missed. The 483 below identifies that some of the basic information for this outage was missed. The 483 doesn’t say what time the outage happened, but if it was...
Stability Testing related News – Vol.2
◆ Revision of the general Chapter on Pharmaceutical Water in the US Pharmacopoeia (15-Jun-16 ECA) The 2nd supplement of USP39 NF34 comprises the revised version of the chapter on pharmaceutical water of the US Pharmacopoeia <1231> Water for pharmaceutical purposes. The first draft version had already been published in...
Operational Qualification (OQ)
The Operational Qualification (OQ) is the fourth document in the validation approval process for bringing a stability chamber online. The OQ testing is a verification that the unit was installed and operates as outlined in the Design Qualification. Figure 1 In the OQ, the testing is designed to have...
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...
US Stability Chamber Manufacturers
Are you looking for stability chamber manufacturers in US? If yes, you can get the list from here with the market reputation we gathered. Then you will be able to find which company will fit to your specific needs. Through the interviews with and facility tours of pharmaceutical companies in...
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...