Analytical Quality Control News

FDA Warning Letter due to Non-Compliance with Specifications

The Indian drug manufacturer Kim Chemicals received an FDA Warning Letter in October 2017. During an FDA inspection, it was criticised that not all medicinal products and the active substances they contained had been tested for compliance with the specifications. Find out more about the Kim Chemicals FDA Warning Letter.

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Specifications and Acceptance Criteria for Impurities: new FDA Principles!

The FDA's Office of Pharmaceutical Quality has published a new MAPP document (Manual of Policies and Procedures) on acceptance criteria and specifications for impurities. In provides principles on the determination of specifications and acceptance criteria for non-mutagenic impurities in authorisation applications, based on clinical relevance. Read more about the Office of Pharmaceutical Quality's new FDA document.

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USP Stimuli Article: Proceedings of the Analytical Lifecycle Workshop 2016

The USP published a stimuli article containing the Highlights of the US Pharmacopeia (USP) and ECA Academy Workshop on the Lifecycle Approach of Analytical Procedures.

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Revision of the USP chapter on Raman

Raman is a technique often used for incoming API and excipients inspection besides IR and NIR. New suggestions for updating the chapter were published in the USP's Pharmacopeial Forum. Find more information on USP chapter <858> Raman Spectroscopy.

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EU Inspection Complaints due to inadequate Handling of OOS Results

The recall of already released batches, the withdrawal of the currently valid GMP certificate and the import ban for Europe are amongst the most notable consequences of an EU GMP inspection in India. The main focus was on faulty OOS management. Read this news for more information about the "Statement of Non-Compliance with GMP" for Dr. Reddy's Laboratories Ltd.

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"Analytical Procedure Lifecycle Management" Guidance for all participants of the APLM Conference

ECA's Analytical Quality Control Group (AQCG) is currently drafting a comprehensive new Guideline on 'Analytical Procedure Lifecyle Management' (APLM) to support the lifecycle approach for analytical procedures. Find out more about this new and important APLM Guidance document and the related APLM Conference.

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Comprehensive Document about the Handling of OOE and OOT Results

How are OOE and OOT results in the pharmaceutical industry to be recorded and assessed nowadays? To answer this question, the ECA Quality Control Working Group and representatives from authorities and industry compiled a guidance document about the handling of Out-of-Expectation (OOE) and Out-of-Trend (OOT) results. Find out more about the 70 page OOS/OOT guidance document.

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How to prepare for a Data Integrity Inspection

Data governance and integrity have been getting more and more in the focus of regulatory inspections. But companies can prepare for these inspections. Find out how planned and periodic internal audits can help companies to prepare for regulatory inspections.

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Missing OOS Trending leads to FDA Warning Letter

The India-based pharmaceutical manufacturer Mylan Laboratories received a Warning Letter by the FDA in April 2017. The FDA inspector found that over 70% of initial OOS results were invalidated without sufficient investigation to determine the root cause of those OOS results and that there was no appropriate trending. Get more information about the Mylan Laboratories FDA Warning Letter.

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Heparin in the FDA's Focus once more: Warning Letter for Chinese Contract Lab

Despite many regulatory initiatives resulting from the heparin scandal, inspections still discover companies linked to contaminated heparin. Read more about the GMP violations concerning the analysis of heparin and the handling of raw data in a Chinese contract laboratory.

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