Analytical Quality Control News

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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GMP Requirements for Certificates of Analysis (CoA)

Certificates of Analysis (CoA) have to be issued for excipients, APIs, packaging materials and finished products. Regarding those certificates, there are a number of guidelines. A closer look at these guidelines shows that there are several regulatory requirements which are often unknown. Read more about GMP/FDA compliant Certificates of Analysis (CoA).

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Proposed Revision of the USP Chapter on Spectroscopic Methods

In the Pharmacopeial Forum of the USP the revision of the General Chapter <197> on Spectrophotometric Identification Tests is proposed. As part of the revision, the sections NIR and RAMAN would be newly included. Get more information about the planned update of the USP on identification tests.

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Revised USP Chapter <1225> "Validation of Compendial Methods" approved

The United States Pharmacopeial Convention (USP) approved a revised version of general chapter <1225> Validation of compendial Methods. Read more about the Validation of Analytical Procedures.

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Elemental Impurities: The Next Steps for the Implementation of ICH Q3D into the European Pharmacopoeia

The EDQM has published the next steps for the implementation of the ICH Q3D guideline in the European Pharmacopoeia. Read more here about the changes in the European Pharmacopoeia regarding the control of elemental impurities in different pharmacopoeia monographs.

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Revised USP Chapter <1058> on Analytical Instrument Qualification

The USP has released a revision of Chapter <1058> on Analytical Instrument Qualification. This chapter set the fundamental requirements on the qualification of different types of instruments in the laboratory. Get more information on the new USP Chapter <1058>.

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New FDA Warning Letter for Wockhardt, Ltd. in India

The manufacturer of APIs and medicinal products Wockhardt in India received an FDA Warning Letter at the end of December 2016. During the inspection, it had been observed that both in GC and HPLC analytics OOS results were excluded from the official records. Get more information about the current Wockhardt FDA Warning Letter.

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Opportunities for Reducing Sampling and Testing of Starting Materials

Chapter 5 of the EC GMP Guide for the area of production was updated last year. This chapter contains concrete information about the conditions when testing and sampling of APIs and excipients can be reduced. Read more here about the sections 5.35 and 5.36 of the EU GMP Guide.

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