Anyone involved in the distribution chain of pharmaceutical products is by now well aware of the increasing responsibility of ensuring their appropriate transportation – to be secure, segregated and temperature controlled. The MHRA, from general Symposium directives to an inspector’s specific action point, are setting-up a framework for greater transit responsibility on everyone’s part.
Validating routes and packaging – a consequence of this greater responsibility – requires time, effort and methodology. The need for presenting test evidence and conclusions, either first-hand or by third party, is rightfully vital in giving confidence in your part of the chain. Quite correctly, your responsibilities and knowledge on the products’ life, should include pre and post storage.
However, the good-will and co-operation of this notion is being potentially watered down by many License holders’ experiences with some of the bigger suppliers. Deliveries, and the transit and packaging conditions, are frequently observed as not being up to a standard that other wholesalers themselves are expected to achieve and maintain. This will also include the paperwork and information received with the products.
As we all know, not everything in a logistics environment can be perfect. Anomalies happen. Therefore, -RP’s, Quality Assurance staff, Directors, everyone – are encouraged and probably expected to start a Non Conformance/Deviation/CAPA process in order to ensure compliance (and an understanding of) this part of GDP guidelines. Not though, with deliveries from the “Big Boys”
There is a general, but understandable, acceptance of the non-compliance here. That to go through the processes mentioned above would be too time-consuming (which, no doubt, it would) and probably be a futile exercise (which it could).
It is true that the large suppliers have tested and qualified a great number of their routes, but there are very few instances of evidence being obtained, or of them ever being customer audited. They are highly professional, responsible organisations who, let’s face it, have plenty of other Guidelines considerations to adhere to. Which they do. But we are effectively, when it comes to many of their deliveries, complying with the non-compliance and accepting what should not be acceptable.
The shrugging-shoulders allowances being made, which we are all party too, are potentially undermining the integrity of the guidelines. It is then a risk that it is excusable to fore-go obtaining further transportation data.
Is it worth considering now that we should be completing those Deviations and CAPA’s where, up until now, we have been reluctant to do so. The MHRA inspectors have a demanding programme, but genuine, repeated and numerous reports of lower than expected delivery standards would not be overlooked for very long – and would lead to a raising in all our standards – which is what we all surely want.
Written by Brian Lindsay