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Wednesday, August 28, 2013

FDA publishes guidance document on capillary Electrophoresis
The ICH Steering Committee recommends that the analytical procedures described in the official pharmacopoeial texts, Ph. Eur. 2.2.47. Capillary Electrophoresis, JP General Information. Capillary Electrophoresis, and USP General Information Chapter <1053> Biotechnology-derived Articles – Capillary Electrophoresis,  can be used as interchangeable in the ICH regions. To view the guidance, CE FDA Guidance

Uncertainty of Measurement-Part 2: OMCL Policy on the Estimation and Application of Uncertainty in Analytical Measurement

To get the copy of Analytical instrument qualification from Agilent technologies click the link  - Analytical Instrument Qualification

Guidance for UK Manufacturer’s Licence and Manufacturer’s Authorisation (for Investigational Medicinal Products) Holders on the use of UK Stand Alone Contract Laboratories
This document:
• Defines a stand alone contract laboratory in relation to quality control testing of medicinal products.
• Provides guidance as to when a contract laboratory must be named on a manufacturer’s licence for relevant medicinal products for human and veterinary use and/or a manufacturer’s authorisation for investigational medicinal products.
• Is applicable to all manufacturing licence holders, i.e. import, export, herbals and specials.
• Provides guidance as to when a contract laboratory is not required to be named on a manufacturer’s licence or authorisation.
• Outlines the MHRA’s criteria for inspection of contract laboratories.
This guidance can be downloaded by clicking Guidance .

Analytical Balance

HPLC Column comparison
To find out alternative column for your column of interest.
HPLC Troubleshooting guide

Instrument calibration
1. Disolution Apparatus 1 & 2 - Mechanical calibration
Calibration of Dissolution Apparatus 1&2
Recently FDA has released a new guidance on Calibration of disolution apparatus 1 & 2. This guidance document more emphasis on enhanced mechanical calibration than chemical performance verification test. This guidance also recommends to manufacturer take appropriate control to handle recognised source of significant variablity during dissolution testing like dissolved gases, vibration and vessel dimensions. For more information go through the link .Guidance to industry -Dissolution

                        Dissolution procedure toolkit
USP released the version 2 of dissolution tool kit procedure for mechanical calibration and performance verification test apparatus 1 & 2. The dissolution toolkit provides a description of best practices associated with the mechanical calibration and performance verification test for the USP basket and paddle dissolution apparatuses and test assemblies.This second version of the dissolution toolkit represents a continuing effort to provide detailed information describing the procedures that if used will assure a properly qualified dissolution test assembly. For more information click Disolution Toolkit Procedure Version-2.
To refer version-1 click Dissolution Toolkit version-1
Further USP established a new acceptance criteria for current lot of Prednisone tablet. For more information click the link Performance of Equipment to Test Dissolution of Medications Further Assured
2. Prednisone tablet for PVT - New lot - P1I303
Prednisone Tablet for PVT - A new lot is released on March 01, 2010 Lot No.P1I300 valid through Feb 29, 2012 with test procedure an optional two stage test and calculation example. On April 30, 2010, Lot P0E203 will no longer be official.
Note: There was an error in the initial USP certificate dated Feb.22, 2010. It is now corrected. For corrected certificate click Prednisone Tablet for PVT - New lot released on March 2010.

Instrument Qualification

Result & Reports

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