Analytical Quality Control News

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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FDA Guideline on Dissolution Testing

The FDA has presented the draft of a revised guideline on dissolution testing for immediate release. Under certain conditions, the tests can now be standardised. Read on to get more information about FDA's Guideline on Dissolution Testing.

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Consequences of the new MHRA Guideline for Excel

In March 2015, the British authority MHRA has summarised and interpreted the existing GMP requirements for data security in a new guideline ("MHRA GMP Data Integrity Definitions and Guidance for Industry"). These requirements apply to all electronically stored data - regardless of the technology used for data saved in MS Excel. Learn more about the relevance of the MHRA Guideline for MS Excel.

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In-process revision to USP <1058> - Analytical Instrument Qualification (AIQ)

An in-process revision to USP <1058> on Analytical Instrument Qualification (AIQ) was issued for public comment in the May-June 2015 issue of Pharmacopoeial Forum. Find out more about the changed version of USP General Chapter <1058> - Analytical Instrument Qualification. 

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