Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
Registered Office: Paradigm Shift Consulting Ltd,The Old Mill, 9 Soar Lane,Leicester, LE3 5DE, United Kingdom
0330 133 0920
We think that £55 + Postage and packing for the Green Guide is a fair price for such a critical publication, but not everyone will agree. If you do agree, click this link and buy it from the Pharmaceutical Press.
We meet many who do invest, but there are also many more who cannot or will not put their hands in their pockets, for whatever justification. Some reasons have been “my boss won’t pay for that” or “that’s expensive.”
Well, there is another option, and it’s free.
The Guidelines on Good Distribution Practice 2013/C 68/01 were revised in November 2013 and are updated to 2013/C 343/01.
The guidelines have been available on the ec.europa.eu website for some months now, and are an excellent resource for newbies and experienced alike.
For ease we link it here;
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2013:343:0001:0014:EN:PDF/
Such guidance can always be open to (mis)interpretation, so it is always wise to speak with knowledgeable colleagues, the MHRA inspectorate or a friendly consultancy company.
• Struggling with your QMS? Don’t even understand what a QMS -is-?
• Not as up to date as you might like, or just want to have a second opinion?
• Worried about a forthcoming inspection or need a third party audit?
• Have you been given critical failures to comply, or been suspended from trading by the MHRA IAG?
The Green Guide goes into further detail on the EU Guidance, making it easier to follow and interpret.
We’re here and we’re ready to assist… and there is no obligation or charge to chat to one of our consultants.
Welcome to a new paradigm!