Pharmaceutical News - June 2011

USFDA Guidance for Industry - Process Validation: General Principles and Practices

In January 2011, the US FDA issued a guidance document that aligns process validation activities with a product lifecycle concept and with existing FDA guidance. This document provides important new guidelines relevant to total organic carbon (TOC) monitoring.

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ASTM E2656 – Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute

ASTM E2656 provides a comprehensive framework for implementing on-line TOC instrumentation within pharmaceutical water systems that is in agreement with current regulatory thinking. To learn more, download our new application note: ASTM E2656 - Process Control and Real-time Release Testing Using TOC.

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Quality System Optimization (QSO) Update

The Quality System Optimization (QSO)™ Program is a risk-based, scientific approach designed to efficiently implement on-line TOC analyzers for real-time release testing (RTRT) of pharmaceutical water. To help our Sievers 500 RL On-Line TOC Analyzer customers align the 500 RL with regulatory expectations and ASTM best-practice standards for on-line TOC testing, we offer a new guidance document for proper and compliant installation of process analyzers.

New Consumables Catalog

Our new Consumables Catalog contains the most frequently-ordered Sievers Certified Reference Materials (Sievers Standards), TOC certified and environmental vials, consumables, and replacement parts for Sievers TOC Analyzers. The catalog offers product information, part numbers, and global ordering information. Download a copy, or contact your local sales representative for a printed catalog.

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New TOC Standards

New to our line of Sievers Standards are specificity and robustness standards for the Sievers 500 RL and 900 Series TOC Analyzers, and standards for compliance with the Japanese Pharmacopoeia. Search for standards by product model on our web site. Please note that we offer standards for almost all TOC analyzer brands.

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JAPANESE LANGUAGE