GMP NEWS 2016

EMA issues new Guideline on "Chemistry of Active Substances"

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.

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End of TTIP? What about the MRA with FDA?

Despite TTIP's intermission, a possible agreement between the EMA and the US FDA on the mutual recognition on drug facility inspections is moving forward.

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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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Serious FDA Warning Letter issued to European Manufacturer of sterile Drugs, Part 1

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.

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FDA Perspective on Risk Management and its Influence on Quality - Inspection Deficiencies 2015

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.

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EMA's Concept Paper on Non-Clinical Documentation for Herbal Medicinal Products published

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.

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ICH M9: Biopharmaceutics Classification System-based Biowaivers

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.

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Selection and justification of starting materials: new Questions and Answers to ICH Q11 published

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.

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EMA revises Process Validation Guideline

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.

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FDA's Quality Metrics Initiative starts with voluntary Phase

The U.S. Food and Drug Administration (FDA) published a revised version of its Quality Metrics Guidance "Submission of Quality Metrics Data".

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Finally: FDA publishes Guidance on Contracts

The US Food and Drug Administration (FDA) finalised its long awaited Guidance on Contract Manufacturer Quality Agreements.

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Serious Violations of GMP and Obstruction to an Inspection: FDA Warning Letter for a Chinese API Manufacturer

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.

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Generics: FDA´s New Guidance on Prior Approval Supplements

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".

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Unusual Warning Letter published by the FDA

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.

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Comprehensive Data Manipulation: New FDA Warning Letter for European Medicinal Product Manufacturer

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.

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EMA/ FDA Mutual Recognition Agreement moving forward

A possible agreement between the EMA and the US FDA on mutual recognition agreement on drug facility inspections could already be signed in January 2017.

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Now online - Stimuli article on the proposed USP General Chapter "The Analytical Procedure Lifecycle <1220>"

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.

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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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ECA Validation Group: Survey Results

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.

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FDA publishes Four Warning Letters in one week

From September 26 to September 29 the US FDA published four Warning Letters. One company is located in China and the other three are based in Europe. Read more about the four FDA Warning Letters

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