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Good manufacturing practice

Notification to MS licence holders due to compliance concerns

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Dropper dropping liquid into a bottle

In January 2015, MHRA published guidance to ‘specials’ manufactures, to provide an interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers. The GMDP Inspectorate have been concerned that some Specials manufacturers have not always been receiving written orders …

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 …

Good Manufacturing Practice (GMP) data integrity: a new look at an old topic, part 3

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Vials in a laboratory

Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. A robust data governance approach will ensure that data is complete, consistent and accurate, irrespective of the format in which data is …