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
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 .
A primer for Good laboratory Practice and Good Manufacturing Practice - For Analytical Laboratories
Analytical Balance
NIST - Weight classification
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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