The new EMA "Guideline on the chemistry of active substances" represents the current state of the art in regulatory practice and fits into the context of the ICH Guidelines Q8-11. Find out what information regarding active substances European authorities expect in an authorization application.
Following serious GMP violations, the American FDA issued an unusually severe Warning Letter to a Hungarian company in October 2016. Severe also because the authority put the company on the list of import bans until the defects have been fixed. Learn more about the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private.
In the framework of a conference on Quality and Manufacturing, David J. Jaworski, Senior Policy Advisor of CDER's Office of Manufacturing and Product Quality gave a presentation on risk management and its influence on quality. The slides of his presentation are now freely available.
In July 2016 EMA's Working Group on herbal medicinal products (HMPC/Committee on Herbal Medicinal Products) published a concept paper on the revision of the guideline on non-clinical documentation for herbal medicinal products. Now in particular genotoxic tests have to be included. Read more about the concept paper on the revision of the guideline on non-clinical documentation for herbal medicinal products.
In October 2016, the International Council for Harmonisation (ICH) endorsed a new topic for the development of a new multidisciplinary guideline M9. Read more about Biopharmaceutics Classification System (BCS)-based biowaivers.
The ICH Q11 Guideline describing approaches to developing and understanding the manufacturing process of drug substances was finalised in May 2012. Since then the pharmaceutical industry and the drug substance manufacturers had time to get familiar with the principles outlined in this guideline. However, experience has shown that there is some need for clarification. Thus the Q11 Implementation Working Group recently issued a Questions and Answers Document.
A News from March 2014 reported about EMA's revised process validation guideline entitled "Guideline on process validation for finished products - information and data to be provided in regulatory submissions". Now, the EMA has surprinsingly published a new revision of its Process Validation Guideline.
At companies where serious GMP violations are observed, a misconduct of the personnel can often be identified during the inspection. A Warning Letter issued to a Chinese API manufacturer describes attempts to obstruct the inspection as well as some typical violations of GMP with regard to data integrity.
Generics: The US Food and Drug Administration (FDA) recently published a new Guidance regarding Prior Approval Supplements (PAS). Read more about FDA´s Guidance for Industry "ANDA Submissions - Prior Approval Supplements Under GDUFA".
In November, 2014, we had reported about the FDA guideline "Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection". This guideline determines how the FDA handles companies that delay, restrict or refuse an inspection or deny access to individual rooms respectively refuse the entire inspection. A current Warning Letter demonstrates the significance of this guideline.
An inadequate access control to the data processing of analytical chromatographic system means in all cases that data can be manipulated. A Warning Letter recently published gives an impressive example of insufficient data integrity in the area of quality control.
A Stimuli Article to the Revision Process regarding the proposed New USP General Chapter "The Analytical Procedure Lifecycle <1220>" has been published. Read more about the new concept for the lifecycle managment of analytical methods.
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.
The ECA Validation Group which currently counts 193 members is one of ECA's seven Working/ Interest Groups. We've asked the members of the Validation Group about their topics of interest and in which direction the group should evolve. Find out more about the survey results.
A Policy Document recently published by the EDQM describes regulations for referencing already existing CEPs in an application for a new CEP. Read more about how the certificates of an intermediate or starting material have to be used in new applications for a CEP.