GMP: Still a GMP problem? Or already a criminal act? Do we need more stringent measures and enforcement in certain situations?

When GMP issues are discussed, different interpretations are possible. Sometimes, the implementation of GMP regulations and expectations can be a challenge. However, everyone involved should do ...

EMA: Regulatory information - European Medicines Agency updates guidance on European Union periodic-safety-update-report single assessment for nationally authorised medicines

The European Medicines Agency (EMA) has updated its procedural guidance to ensure that marketing-authorisation holders are prepared for the submission of periodic safety update reports (PSURs) for ...

EMA: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on ...

RAPS: As FDA Tries to Regulate Lab-Developed Tests, Congress Signals Potential Opposition

On 1 August 2014, FDA released a new draft guidance document, Framework for Regulatory Oversight of LDTs, that proposes regulating LDTs more or less like IVDs. Under FDA\'s proposed regulatory ...

GMP: Questions and Answers on the Topic \"Pharmaceutical Water\"

During courses and conferences participants quite frequently raise questions on pharmaceutical water preparation and distribution. Therefore following you will find some of these questions and ...

GMP: ECA and PQG publish next chapter of the GDP Interpretation Guide

The Pharmaceutical Quality Group (PQG) and the GDP Interest Group of the ECA Foundation have established a task force which is currently working on the interpretation of the EU Good Distribution ...

EMA: The European regulatory system for medicines and the European Medicines Agency - A consistent approach to medicines regulation across the European Union

This booklet is intended to explain how the European regulatory system for medicines operates. It describes how medicines are authorised and monitored in the European Union (EU) and how the ...

EMA: Draft template for the qualified person’s declaration concerning good-manufacturing-practice compliance of the active substance used as starting material and verification of its supply chain \'the QP declaration template\'.

The objective of the QP Declaration Template is to emphasise the importance of providing a valid declaration, to harmonise the format for the declaration, to forestall questions during assessment, ...

GMP: Which SOPs are required by GMP?

The ECA Academy is receiving a lot of questions on SOPs (Standard Operating Procedures) needed in a GMP environment. The most interesting is the one on which SOPs are required by law. ...

RAPS: FDA Outlines New Communication Process for Generic Drug Companies

The US Food and Drug Administration (FDA) is out with its fourth draft guidance document under the 2012 Generic Drug User Fee Act, this time explaining the nuances of how generic drug companies ...

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