Article archive

Dissolution Testing - Planned Revision of the USP Chapter

23/04/2014 17:37
A "Stimuli to the Revision Process" article on the development and validation of dissolution testing methods has been published in the Pharmacopoeial Forum 40(1). The revision of General Chapter <1092> is planned.  General Chapter <1092> should be read together with the general...

New EMA Guideline on Stability Testing for Applications for Variations

23/04/2014 17:29
Which stability data must be submitted in the context of an application for variations regarding marketing authorisations in the EU? A new EMA Guideline entitled "Guideline on stability testing for applications for variations to a marketing...

Combined Risk Assessment for Analytical Instruments and Computer Systems in the Laboratory

16/04/2014 18:13
An article Focus on Quality in the journal Spectroscopy from November 2013 describes the risk assessment for instruments and computer-based systems in the analytical laboratory. In the USP chapter < 1058 > analytical instruments are divided into the 3 groups A, B and C. Chapter < 1058...

Integrity and Security of Medicinal Products Supply Chains - New Instructions in the US-American Pharmacopeia (USP)

16/04/2014 18:08
A new series of General Chapters on the different aspects of the pharmaceutical supply chain ("Good Distribution Practices") which should replace the current chapters on the topic has been published in the Pharmacopoeial Forum 40(1). A review of the current chapters (<1079>, <1083> and...

New EU GMP Guide Chapter 6

16/04/2014 18:02
In early April 2014, the EU Commission has published a new chapter 6 Quality Control. The new chapter will become effective on 1 October 2014. The main reasons for the changes (as e.g. the insertion of a new chapter on transfer of analytical methods) were already known. The now published document...

FDA published Guidance for Industry on "Investigation Device Exemptions (IDE)"

10/04/2014 18:39
At the end of 2013, the FDA released the final version of the Guidance for Industry and FDA-Staff on "Investigation Device Exemptions (IDEs) for Early Feasibility Medical Devices Clinical Studies Including Certain First in Human (FIH) Studies". This is the final version of a draft from November...

FDA published Medical Device Recall Report

10/04/2014 18:35
The FDA has published an overview over the evolution of medical device recalls between the fiscal years 2003 and 2012. In 2010, the FDA started an initiative to improve recall processes in order to enhance public health. The report should thus help to increase understanding between the FDA and the...

FDA plans Changes to the Classification of Medical Devices

10/04/2014 18:31
At the end of March, the FDA announced in the Federal Register that changes to 21 CFR 860 (Medical Device Classification Procedures) were planned. Chapter 860 is divided into 3 subchapters (General, Classification, Reclassification). Based on risks, the classification includes 3 classes (class I,...

Overview of new CDRH Guidelines

10/04/2014 18:28
The Center for Devices and Radiological Health (CDRH), responsible for medical devices at the FDA, publishes new guidelines and programmes on a regular basis. Following you will find a short and selected overview of new, modified, or updated guidelines and programmes.   The guideline "Design...

New FDA Guideline on Size, Shape and Physical Attributes of Generics

10/04/2014 18:21
At the end of 2013, the FDA published a guideline draft entitled "Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules". The Agency saw a need for regulation because of the fact that the dosage forms of generics - particularly tablets and capsules - may considerably differ...
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