GMP News - Analytical Quality Control

20.12.17

Now online: Draft ICH Q12

The long awaited and highly discussed ICH Q12 draft Guideline is now available online on the ICH website. Read more about ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.

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13.12.17

USP <381> Elastomeric Closure for Injections

The USP General Chapters Packaging and Distribution Expert Committee recently posted the intent to revise General Chapter <381>. The Chapter currently includes a reference to <231> Heavy Metals, which will be omitted on January 1, 2018. Read more about the revision of Chapter <381> Elastomeric Closure for Injections.

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06.12.17

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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06.12.17

Draft DIN EN ISO Injection Vials made of Tubular Glass

The DIN EN ISO committee published a draft for DIN EN ISO 8362-1 Injection vials made of glass tubing for comment.

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15.11.17

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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25.10.17

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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18.10.17

Rationale to the revision of USP Chapter <381> Elastomeric Closures for Injections

The USP has recently undertaken an in-depth review of chapter <381> which has resulted in significant revisions especially to the heavy metals and functionality tests. In a stimuli article the USP now provides the rationale for the proposed changes to USP general chapter Elastomeric Closures for Injections <381>.

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17.10.17

"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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04.10.17

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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06.09.17

Test for Subvisible Particles: ICH Harmonisation Completed

With Step 5, harmonisation regarding the use of pharmacopoeial methods for test for subvisible particles in the ICH regions has been completed. Read more about Tests for Subvisible Particles.

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09.08.17

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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21.06.17

Elemental Impurities - Binding Risk Assessment for Authorised Medicinal Products

EMA's document on the implementation of ICH Q3D for already marketed products contains essential recommendations for marketing authorisation holders. Learn why risk assessments with regard to elemental impurities for existing marketed products are so important and how to decide about the necessity of a variation procedure.

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14.06.17

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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07.06.17

FDA Warning Letter shows the Importance of Sampling Plans and Strategies

A recent FDA Warning Letter cited a lack of scientifically sound and appropriate sampling plans for inspection. It stated that the company had no scientific justification for the number of reserve samples selected for the yearly visual examination aimed at identifying any evidence of drug product deterioration. Similarly, the company lacked appropriate statistical sampling plans for the inspection of paper label rolls.

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03.05.17

FDA Warning Letter due to incorrect HPLC and UV Data

In January 2017, Sato Yakuhin Kogyo Co. Ltd., a pharmaceutical company in Japan, received a Warning Letter from the FDA. During the FDA inspection, incomplete data were criticized in the HPLC and UV analysis. Find out more about the FDA Warning Letter issued to Sato Yakuhin Kogyo.

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