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Good distribution practice

1st birthday - reflections on the last year of blogging

Birthday cake with one lit candle

A year ago today we launched the MHRA Inspectorate blog.  Now, after 12 months of activity it’s a good time to reflect on where we are and what’s to come.

Qualification of customers, what wholesalers need to know

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice, Good manufacturing practice
Blister pack of mediicnes

In my last post I talked about the importance of ensuring medicines are only obtained from qualified suppliers. Equally important is the obligation distributors have in ensuring that only wholesalers or persons entitled to supply or administer medicines receive medicinal products. …

Refrigerated medicinal products, part 2: Transportation, packing, temperature management, the use of third party couriers and returns – some things to consider

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Refrigerated transportation

This is the second of two blog posts dealing with the management of refrigerated medicinal products and like the first, draws on some of the findings from GDP inspections, references to the EU GDP Guidelines 2013, the Green Guide and …

Good Distribution Practice - Qualification of suppliers, a helpful reminder of the 3 steps needed to assure supply chain integrity

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Front cover of the 2015 Green Guide

We have recently had a number of situations where companies have not understood the obligations placed on them by the Human Medicines Regulations 2012 Regulation 44 (2) and (3) and Good Distribution Practice in relation to qualification of suppliers. In …

Refrigerated medicinal products, part 1: receipt and storage - some things to consider

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Industrial cold store scene

Patient safety is the end objective for manufacturers, wholesalers, distributors and those healthcare professionals administering to patients. This blog is in 2 parts and draws on some of the findings from good distribution practice (GDP) inspections, references to the EU GDP …

PIC/S - Press release and news of MHRA chair in 2016/17

Attendees at the 2015 PIC/S Annual Seminar, Indonesia

Back in October I attended, with MHRA colleagues, the PIC/S (Pharmaceutical Inspection Co-operation Scheme) committee meeting and annual seminar that was this year hosted by the Indonesian National Agency for Drug and Food Control (NADFC). In the new year I'll …

Helping us to help you – 5 top tips for making enquiries to the MHRA Inspectorate

Helping us to help you by a) check our blog/pages of the website, b) be specific by which GXP your query relates to c) be specific about what your query relates to d) be specific about which company/site your query relates to e) give your proposal of what you intend to do

The MHRA Inspectorate receives several hundred enquiries via email each year. Answering queries is one of the key ways we support industry. It provides reassurance to our stakeholders, aiding them in their decision-making processes, helping to ensure they don’t fall …

Supply of unlicensed medicines when an equivalent licensed product becomes available

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blister pack

We've had a number of instances where licensed versions of commonly supplied unlicensed medicines have become available.  We want to remind stakeholders what to do if this happens. Recent examples of newly licensed products of this nature include fomicyt, 40mg/ml fosfomycin …