Good Weighing practice for lab and production balance

DRUG REGULATORY AFFAIRS INTERNATIONAL

Good Weighing practice for lab and production balance

Introduction

Weighing raw materials, product, reagents, excipients and other product related materials is a risk procedure in the Biotechnology and Pharmaceutical areas. Any weighing mistake in case not detected immediately, may affects the final drug substance/drug product purity, strength, quality and safety and may lead to recall or even to harm the patient health.

As part of GMP audits, many FDA 483 warning letters included comments regarding inappropriate balance and weighing process in production departments as well as in QC laboratory. Very often we face pharmaceutical and biotechnology companies using balance which does not comply the required characteristics such as minimum weight, certainty, accuracy etc…….

read all at

http://bio-chem.co.il/good-weighing-practice-lab-production-balance/

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