Skip to content
For Your Best Storage Process
For Your Best Storage Process
Develop the best process for stability storage in the pharmaceutical industry and make it available worldwide
  • Home
  • Service
  • About
  • Contact

Posts Tagged with Documentation

Pest Control Records

Pest Control Records

January 30, 2017

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...

Continue

Stability Chamber Qualification

Stability Chamber Qualification

October 6, 2016

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...

Continue

Performance Qualification (PQ)

Performance Qualification (PQ)

September 23, 2016

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...

Continue

Equipment Outages Documentation

Equipment Outages Documentation

August 28, 2016

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...

Continue

Installation Qualification – IQ

Installation Qualification – IQ

July 18, 2016

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...

Continue

Design Qualification – DQ

Design Qualification – DQ

July 3, 2016

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...

Continue

User Requirements Specification – URS

User Requirements Specification – URS

June 12, 2016

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...

Continue

BIOCOM’s LifeLines summer 2016

BIOCOM’s LifeLines summer 2016

June 6, 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.    

Continue

FDA 483 Tips #5

FDA 483 Tips #5

May 29, 2016

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...

Continue

FDA 483 Tips #4

FDA 483 Tips #4

May 24, 2016

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....

Continue

Older Posts
  • Home
  • Service
  • About
  • Contact
  • Terms of Use
  • Your Privacy Rights
Copyright © 2021 NAGANO SCIENCE USA, INC. All rights reserved.