Another FDA Warning Letter with Focus on "Data Integrity"
The US FDA has a new focus of their inspections: the review to the integrity of data. A recent Warning Letter from July 2015 shows again a clear focus on the issue of data integrity. Please find more information in the Current FDA Warning Letter regarding Data Integrity.
New USP proposal for updating identity checks in U.S. Pharmacopeia
New proposals for checking identities have been introduced in a USP article and published in the Pharmacopeial Forum, together with the planned chapter revision <191>. In future, the checks will be much more flexible. Find out more about the planned Update of the Identity Check in the U.S. Pharmacopoeia.
FDA Guidance on analytical procedures and methods validation published
The FDA Draft Guidance on Methods Validation has recently been revised and finalised. Please read about some important points required by this Guidance regarding validation of analytical test procedures.
The actual questions and answers on the quality of herbal medicines and traditional herbal medicines were revised in January 2015 within the fifth revision. The question on the testing with respect to benzene impurities was newly added. Find out more about the HMPC Q&A Document.
The International Conference on Harmonisation (ICH) wants to facilitate the implementation of their Guidelines and other documents through issuing new training materials. Just recently the ICH has updated their website with new materials on Q3D.
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>.
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.
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.
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.
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.