Every batch of medicinal product must be certified by a Qualified Person (QP) of the EU manufacturer or importer before being released for sale. The certifying QP takes responsibility for ensuring that each batch has been manufactured and checked in …
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. …
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 …
We are aware there is some concern for UK business and personal careers, over the status of transitional QPs that were recognised under the transitional arrangements provided in SI 2004/1031, when the Clinical Trials Directive was implemented in 2004. The …
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 …
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 …
Not to be outshone by our GDP colleagues, this post is to communicate the highlights from the GMP days at the 2015 MHRA Symposium. I’m Michelle Rowson, a GMDP Operations Manager, and part of my role is to lead in planning …
Welcome to the latest MHRA GDP blog post! I’m Claire Glenister, a GDP Inspector who has been working for the agency for 3 years. This blog is to communicate highlights from the 2015 GDP days at the MHRA Symposium, at …
We are aware there is some concern for UK business and personal careers, over the status of transitional QPs that were recognised under the transitional arrangements provided in SI 2004/1031, when the Clinical Trials Directive was implemented in 2004. The …
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 …
