5 Reasons to Keep the Legal Department Away from your Quality Agreements

5 Reasons to Keep the Legal Department Away from your Quality Agreements

As consultants for the pharmaceutical industry, one of our services is setting up and negotiating (technical) quality agreements between suppliers and customers. We usually work for the pharmaceutical customer, so we wrote this blog from that perspective. We do realize that quality agreements go by different names, such as technical agreements, TQAs, QTAs, QAAs, etc. In this blog, however, we consider

Read More

Counting down the no-nos  during audits: BONUS – a yes-yes -: The CAPA we really like to see again!

Counting down the no-nos during audits: BONUS – a yes-yes -: The CAPA we really like to see again!

As auditors for the pharmaceutical industry, we have the opportunity to visit the most wonderful places as well as the most interesting companies. We are lucky enough to conduct audits all over the world. Apart from visiting some exemplary companies, we sometimes encounter things we would rather not see. In these last few weeks of 2018, we are counting down the

Read More

Counting down the no-nos  during audits: Number 1: Bribing the auditor

Counting down the no-nos during audits: Number 1: Bribing the auditor

As auditors for the pharmaceutical industry, we have the opportunity to visit the most wonderful places as well as the most interesting companies. We are lucky enough to conduct audits all over the world. Apart from visiting some exemplary companies, we sometimes encounter things we would rather not see. In these last few weeks of 2018, we are counting down the

Read More

Counting down the no-nos  during audits: Number 6: Do not mind that liquid spill, that is probably harmless

Counting down the no-nos during audits: Number 6: Do not mind that liquid spill, that is probably harmless

As auditors for the pharmaceutical industry, we have the opportunity to visit the most wonderful places as well as the most interesting companies. We are lucky enough to conduct audits all over the world. Apart from visiting some exemplary companies, we sometimes encounter things we would rather not see. In these last few weeks of 2018, we are counting down the

Read More