GMP News - Analytical Quality Control


New General USP Chapter <1210> on Statistical Tools for Procedure Validation

In the Pharmacopeial Forum the USP presented the new General USP Chapter <1210> on Statistical Tools for the Validation of Analytical Procedures. Get more information on the Chapter <1210>.



Revision of the General USP Chapter <1010>

The USP announced a revision of the general USP Chapter <1010> for the treatment and interpretation of analytical data in Pharmacopeial Forum. Find out more about the Revision of the General USP Chapter <1010>.



Data Integrity: New Inspection Focus of the FDA

Reviewing data integrity is FDA's new inspection focus. Concerning this, new requirements in form of questions and answers have been added to FDA's Q&A webpage on Current Good Manufacturing Practices. Also the recent Warning Letters indicate a clear focus on the data integrity topic. More information can be found here in the News.



GMP Data Integrity: New MHRA Guideline

In January the MHRA, UK, published a Guideline on data integrity in the GMP environment. Now, a data governance system for data in the GMP manufacture and analytical laboratories is required in addition to the existing quality systems. More information can be found here in the News.



Elemental Impurities: USP announces the Date of Entry into Force of Chapters <232> and <2232>

A few days ago, the USP announced its approach to the revision of the General Chapters on metal impurities. Read more here.



CHMP adopts ICH Q3D Guideline as "Scientific Guideline"

The ICH Q3D Guideline recently published has been integrated into EMA's set of rules. The coming into force of the requirements laid down in this guideline now underlies defined deadlines. Read more here.



USP's New Requirements for Compendial Validation

Which information is needed for compendial validation to include a method in the US American pharmacopeia USP/NF? In an article published in the Pharmacopeial Forum, the USP is proposing concrete requirements for compendial validation. More information can be found here.



System Suitability for USP Chromatographic Methods

How should system suitability tests (SSTs) be structured for USP monographs? More about USP experts group's recommendations on the parameters and acceptance criteria for SSTs and the essential aspects of this new approach can be found in this News.



ECA SOP: Methods for the Identification of Trends in Production and QC

An SOP on the handling of Out of Trend Results is the objective of ECA Working Group on QC. Both trend analysis of statistical process control in the production as well as trend analysis in stability studies will be addressed. More information can be found here in the News.



How to identify Out-of-Trend Results in Stability Studies?

Different methods for the identification of OOT results in ongoing stability studies have been described in a PharmTech article. The conclusion is that there is an enormous need for a regulation with regard to this topic. More information can be found in the News.



FDA publishes ICH Q4B - Annex 6 on Uniformity of Dosage Units

The ICH Guideline on Uniformity of Dosage Units was published in June 2014 by the FDA and thus became effective in the USA. More information can be found here.



What is the difference between OOS / OOE / OOT?

In the meantime - beside OOS results - the terms OOE and OOT have become more and more frequent. But what do those abbreviations mean? How to implement the handling of OOS, OOE and OOT results in practice? More information can be found here.



Handling of OOS Results in Europe

FDA's Guidance on Out-of-Specification Results has been seen as the state of the art regarding the handling of OOS results. In the meantime, Europe - through the British MHRA and the German ZLG - has also developed requirements on that topic. Read more here about the most important regulations of the respective guidance documents.



EMA NIR Guideline finalised

The EMA has published the final guideline on the use of Near Infrared Spectroscopy (NIRS). NIRS is one of the most important technologies in PAT applications. The guideline covers qualitative and quantitative NIRS applications. Particularly worth mentioning is the fact that an addendum on the guideline's scope was published just in June 2014. You will find further information in this news.



EMA publishes Document on the Validation of analytical Methods

Is it possible to use the results of collaborative trials for analytical methods to prove the laboratory- and product-specific validation of a method? From the perspective of this EMA reflection paper the concrete specifications are missing. These will be developed in the future. Find out more in this news.


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