During the course of our work we see many SOPs and often come across procedures that are difficult to read and do not clearly describe the procedure. A long SOP does not necessarily make it a good one! When writing an SOP it is worth thinking about what its purpose is...

Over the past few years we have seen a move towards risk based quality systems with risk being emphasised much more in the new Guidelines for Good Distribution Practices. But what does this mean to you and how do you put it into practice? The thing with risk...

We are living in a fast moving regulatory environment which has to address advances in products & technology, changing practices, safety issues, global markets and much more. Not keeping up with these changes can present a threat to the compliancy of your...