Good Distribution Practice deficiencies

One of the advantages of working with several companies and in different locations as a contract RP, is having the opportunity to work with a number of different MHRA GDP inspectors and to learn from them what matters are most important to them at premises licence inspections and re-inspections.

Over the last year, I have seen quite a variation in the detail of what matters at an inspection, and from that I have learnt that one really needs to cover as many bases as possible prior to inspection, as almost anything can be brought up, and often is!

Temperature control has certainly received much more emphasis over the last couple of years, and perhaps with global warming this is understandable, as even the UK now can expect a few days, if not a week or two, of 30C plus days, when an un-cooled warehouse could easily exceed 25C. The transportation of cool chain items logically also has received more focus. In the last couple of weeks we have also experienced the opposite problem, and preventing a poorly insulated warehouse or goods in transit  from freezing may have challenged some.

Whilst relatively uncommon, I have also seen interest in ensuring that :

* the authority level and responsibilities of RPs is clearly spelt out in Job Descriptions and/or in technical agreements.

* computer systems in use are properly validated

* controlled secure access to premises works

Later this year it is likely that all Wholesale dealers will have to put in place a Quality System, not necessarily an ISO type system, if an EU consultation conducted at the end of 2011 is enacted without significant modification of proposals. Watch this space for more on this when it becomes known.