Monthly Archives: January 2012

GMP Directive (2003/94/EC) to cover active substances?

Posted on January 24, 2012 by

The European Commission are proposing to extend the scope of Directive 2003/94/EC to cover active substances, including the manufacture of active substances. The intent is to bring cohesion of requirements for active substances and medicinal products. However, since all of … Continue reading →

Posted in Compliance, GMP, Regulations | Leave a comment

Is it OK to “manipulate” PDFs to improve records management?

Posted on January 23, 2012 by

This is a question that I hear posed fairly frequently, I guess as a result of organisations managing electronic records rather than – or in addition to – traditional paper records. A typical scenario is an electronic document received into the … Continue reading →

Posted in Compliance, e-records, Litigation, Records management practice, Regulations | 1 Comment

Certification by a qualified person and batch release – Consultation

Posted on January 5, 2012 by

A concept paper on revising Annex 16 of the guide to good manufacturing practice: certification by a QP and batch release is currently open for consultation until 31/01/2012 using the following link to the EMA website: http://bit.ly/yTocBW The concept paper … Continue reading →

Posted in Regulations | Tagged , , , , | Leave a comment