GMP News - Pharmaceutical Development / Clinical Trials / GCP

30.08.12

Novel Manufacturing Strategy: Continuous Manufacturing - Development Case Study

The pharmaceutical industry is still dominated by 'frozen' batch processes with little, if any, automatic feedback control. Time is now for the pharmaceutical industry to evolve from the 'frozen' batch manufacturing process characteristic to automatic controlled continuous manufacturing in the future. Please find more information in this news, dealing with an article from Prof. Dr. Fernando Muzzio about the development of continuous manufacturing processes for the manufacture of pharmaceutical tablets.

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14.08.12

Draft on New GCP Directive 2001/20/EG

The GCP Directive 2001/20/EG will be revised. The EU Commission has published a draft accompanied by additional documents. Read more here.

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14.08.12

ATMP - EMA Reflection Paper on Classification of Advanced Therapy Medicinal Products

Recently, the European Medicines Agency published an Reflection Paper on classification of advanced therapy medicinal products. This document is open for consultation until 31 July 2012. Read on.

 

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06.06.12

New IMPD Guideline on the Requirements for Quality Documentation concerning Biological Investigational Medicinal Products in Clinical Trials

The new IMPD Guideline - which has been recently published by the EMA - describes the requirements for quality documentation concerning biotechnological investigational medicinal products and provides - among other things - statements about shelf-life extension. Get more here.

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30.05.12

Quality documentation concerning biological investigational medicinal products in clinical trials

In May the European Commission published the Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials. It addresses the specific documentation requirements with regard to biological, chemical andpharmaceutical quality of IMPs containing biological / biotechnology derived substances. Get the details.

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16.05.12

Development and Manufacturing of APIs: Final ICH Q11 Document Published!

One year after the publication of the Draft Consensus Guideline ICH Q11 "Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)", the finalised document has been released. Read more here about the new guideline.

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16.05.12

Which Information on Stability of Pharmaceutical Bulk Products is required in the Application Dossier?

Bulk products used in the manufacturing of medicinal products are subject to the same GMP regulations as APIs and finished products regarding storage and transport. The respective guidelines only provide unclear information about the data required for the application dossiers. The EMA has now closed this loophole with the publication of a Questions and Answers document. Read more.

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16.05.12

EMA strengthens Oversight on Clinical Trials outside EU

The European Medicines Agency (EMA) has published the final reflection paper concerning ethical and good clinical practice (GCP) aspects of clinical trials conducted outside of the European Union (EU)/European Economic Area (EEA). Read more.

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03.05.12

FDA wants to facilitate Drug Development with new Tools

The U.S. Food and Drug Administration (FDA) has introduced a set of Qualification Programs which may facilitate drug development through novel tools. Read more.

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18.04.12

How to Implement Design Control for Combination Products within Pharma?

The term "Design Control" was originally used only in the development and manufacture of medical devices. In the meantime "Design Control" became an important issue for the development of pharmaceutical drug products just as well. There are more and more requirements and requests from the regulatory authorities relating to "Design Control" for Combination Products. For people working in the pharmaceutical industry it is a challenge to transfer all these new terms to their existing and traditional development processes. Read more.

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18.04.12

EU Clinical Trials Register in co-operation with WHO

Information contained in the European Union (EU) Clinical Trials Register is now also available through the WHO International Clinical Trial Registry Platform (ICTRP). Read more. 

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14.03.12

Transitional Regulations for the New Pharmacovigilance Package: Commission's Q&A Document provides Clarity

The new pharmacovigilance package and its regulations which are entering into force in April and respectively in July this year prompt questions - mainly regarding deadlines for renewal applications for medicinal products authorisations. The EU Commission has published a Q&A document to answer these questions and to clarify further ones (e.g. about the pharmacovigilance system master file). Read more here.

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01.02.12

FDA: QbD becomes mandatory for Generics

To support generic manufacturers, the Office of Generic Drugs (OGD) has published a 161 page example of a fictitious modified release tablet formulation. Read more.

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09.11.11

New QP Declaration for managing Expiry Dates of IMPs

In the recently published EMA Reflection paper on IVR/IWR systems, an additional QP Declaration is introduced for managing expiry dates.  Read on here.

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09.11.11

MHRA announces Good Clinical Practice (GCP) Discussion Forum

The U.K. Medicines and Healthcare products Regulatory Agency MHRA has created a GCP Discussion Forum. Read more.

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