Analytical Quality Control News

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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FDA Warning Letter due to Incorrect Sampling

Incorrect sampling has led to an FDA Warning Letter for an API manufacturer in China. The FDA inspectors criticised that around 10% of the API batches manufactured exceeded the impurity limit set. Read more about this FDA Warning Letter.

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FDA Warning Letter due to incorrect Certificates of Analysis

At the beginning of March 2017, Lumis, an API manufacturer in China, received a Warning Letter from the the US FDA. During the FDA inspection the certificates of analysis (COAs) were criticized. The issued certificates did not contain all relevant information on the quality that would have been necessary for the customer. Learn more about the FDA Warning Letter issued to Lumis.

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EMA's new Guideline on the Implementation of the ICH Q3D Guideline in the EU

Recently published, the EMA Guideline on the implementation of the requirements of the ICH Q3D Guideline provides support for API and medicinal product manufacturers. Learn more about what you have to consider with regard to the justification and documentation of elemental impurities in the dossier for a marketing authorisation.

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Recognition of Alternative Compendia (BP/EP/JP) by the FDA

In January 2017, FDA's Office of Pharmaceutical Quality revised the document "MAPP 5310.7" on the acceptability of standards from alternative compendia. This important FDA document is often unknown among the pharmaceutical industry. Learn more about the most important aspects of FDA's document "Acceptability of Standards from Alternative Compendia (BP/EP/JP)".

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