A Pest Control program needs to look at not only rodent control, but also flying and crawling insects. The program needs to be adequate to ensure that these contaminations are minimized to the lowest level possible. Buildings used in the processing of a drug product are not maintained...
Posts Tagged with Documentation
Stability Chamber Qualification
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...
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...
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...
BIOCOM’s LifeLines summer 2016
Have you seen BIOCOM’s LifeLines summer issue? See page 21. We are there! You can also get LifeLines at 2016 Bio International Convention.
FDA 483 Tips #5
Related FDA483/Warning Letter The written stability program for drug products does not describe the storage conditions for samples retained for testing. Specifically: Sub section (b)There is no written standard operating procedure in place to (A) control, secure, and allow authorized personnel to access the stability chambers. It appears that...
FDA 483 Tips #4
Procedures describing the calibration of instruments and apparatus are deficiently written or followed. Related FDA483/Warning Letter b) The two calibration points evaluated were 0 C and 100 C, thus there was no challenge to the actual range of operation which were mentioned to be C to C....