LOGISTICS TECHNICAL AGREEMENTS

Many transport services in the distribution and supply of medicinal products are carried out by external logistics service providers, and many other activities in the GDP environment are often outsourced also. In this context, the question arises on when is it necessary to sign a Technical/Quality Agreement? Which regulatory requirements apply? and which aspects should be covered in such an agreement?..

Temporary Regulatory Flexibilities

In its Inspectorate Blog the MHRA published a post on temporary changes in Good Distribution Practice (GDP) entitled “How to manage temporary GDP process changes and risks through the COVID-19 pandemic”…

China Vs Counterfeiting

With a number of reports from over the pond of Mr Trump praising China, even in areas where I think most sane people will think ‘there is room for improvement’, I am a little reluctant to join in but credit where it is due…

API and Clinical Trails Training

Shankar Seetharaman is a Qualified Person with many years of experience in API auditing and clinical trials supply. He currently is the Managing Director of Pharmanswers Ltd which is a consultancy with a proven track record of providing quality and regulatory support for the pharmaceutical industry…

UK trade agreement

More trade is essential if the UK is to overcome the unprecedented economic challenge posed by the Coronavirus. The UK’s priority is to launch negotiations with the EU, the US, Australia, New Zealand and Japan…