When I first started work (many years ago I might add), there were no calculators, no computers and no smart phones. There was […]
Final GDP Guideline published by EU Commission
The long awaited EU GDP Guideline was published in the Official Journal of the European Union by EU Commission on 7 March 2013. […]
Regulatory/GMP
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
Written Confirmation of Active Substances used in medicinal products marketed in the EEA will become effective in July 2013 in accordance with Directive […]
GxPpro Training Courses
GMP in a Nutshell e-learning module to be available from 1st March 2013. This course is aimed at new employees as part of […]
GDP guidelines
Guidelines on the Principles of Good Distribution Practice for Active Substances for Medicinal Products for Human Use. There is a document out for […]
Quality Risk Assessment
Guidelines on the Formalised Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal Products for Human Use. This guideline […]
Do all inspections cover the quality risk management process?
Yes, quality risk management (QRM) is a requirement of Chapter 1 of the EU GMP Guide Part I and Annex 20. All manufacturing […]
Should a company have a procedure to describe how it approaches QRM related to manufacture and GMP?
Yes, the procedure should be integrated with the quality system and apply to planned and unplanned risk assessments. It is an expectation of […]
What are the key attributes of a good risk assessment?
The following key attributes should be observed (mindful of the risk significance addressed in the previous question): clearly identify the process being assessed […]