The long awaited EU GDP Guideline was published in the Official Journal of the European Union by EU Commission on 7 March 2013. […]

Pharmaceutical Quality Systems (Chapter 1of Eudralex) became effective on 31st January 2013. The requirement for utilising Quality Risk Management is also becoming even […]

Written Confirmation of Active Substances used in medicinal products marketed in the EEA will become effective in July 2013 in accordance with Directive […]

GMP in a Nutshell e-learning module to be available from 1st March 2013. This course is aimed at new employees as part of […]

Guidelines on the Principles of Good Distribution Practice for Active Substances for Medicinal Products for Human Use. There is a document out for […]

Guidelines on the Formalised Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal Products for Human Use. This guideline […]

Yes, quality risk management (QRM) is a requirement of Chapter 1 of the EU GMP Guide Part I and Annex 20. All manufacturing […]

Yes, the procedure should be integrated with the quality system and apply to planned and unplanned risk assessments. It is an expectation of […]

The following key attributes should be observed (mindful of the risk significance addressed in the previous question): clearly identify the process being assessed […]

In reality there is always a degree of risk in all situations but mitigation controls should minimise the likelihood to an acceptable level […]