Category: Paradigm Updates

General news items, around pharmacy, pharmaceuticals and deals or offers.

  The question is often asked “What temperature should a products in a wholesale area be kept at”, and the answers can vary wildly depending on who you speak to. The primary response to this question should be “Under label conditions” or “As per the outer packaging.” So, what are the temperature ranges that the…

Are you planning on becoming a Responsible Person for a pharmaceutical wholesaler? Do you fit the criteria laid out by the National Competent Authority, the MHRA? The Gold Standard for Responsible Persons has been in laid out for over two years at the date of writing this blog, and when the MHRA carry out a…

Consultants from Paradigm Shift have supported a number of companies in their journey out of MHRA licence suspension, some of whom had taken legal advice, or had engaged solicitors to fight their case, in advance of contacting us. Quite often by the time Paradigm are contacted it’s too late. Typically we receive notice from people just…

Quality can be built in to your systems… and it should be. For those of us who want to build and run a successful and consistent wholesale business standard operating procedures are a good start… but not everything. If you have Standard operating procedures (aka SOPs) do you follow them? Are they reflective of the…

We see frequently that sites share their wholesale Standard Operating Procedures aka SOPs, which in some cases can be a good thing… if the wholesale SOPs are of a high quality and are tailored for the specific site… or a significant problem if they are wholesale SOPs for a different business model, or out of date. A…

Every wholesaler should be actively subscribed to the medicine recall and drug alerts and be aware of their responsibilities for carrying out recalls within the time limits required. If no recall happens during the year the licence holder must carry out a dummy recall. This has historically been a big part of non-compliance with GDP, however…

With the Falsified Medicines Directive coming (slowly) to fruition, it will be pharmacies and wholesalers bearing the brunt of the changes in the continual pursuit of patient safety. Sultan “Sid” Dajani, Chairman of the Falsified Medicines Directive at the Royal Pharmaceutical Society,  and UK Representative for the Pharmacy Group of the European Union (PGEU), has kindly written…

Are your suppliers and customers validated or bona fide? bona fide ˌbəʊnə ˈfʌɪdi/ adjective 1. genuine; real. “she was a bona fide expert” Synonyms: authentic, genuine, real, true, actual, sterling, sound, legal, legitimate,lawful, valid, unadulterated, unalloyed, proper, straight, fair and square. Bona fides checks are a critical piece of the GDP puzzle. Within the EU Guidance 2013/C 343/01 the term “bona fide” is not used, however this is a common…

  Does your GDP Quality Management System identify risks to patient and product safety? If not, why not? Need help? Then read on. The EU GDP Guidelines mentions risk and risk identification for the first time ever; 1.5. Quality risk management Quality risk management is a systematic process for the assessment, control, communication and review…

Paradigm Shift Consulting Limited offer a range of GDP training solutions, to fit all business models, and pockets. Click <HERE> to see our next training dates. Whether you are a pharmacy skimming model with a requirement for Responsible Person/RP refresher training or want Driver GDP training or Basic GDP Training for your new staff, we can help….

  Cogent SSC have officially announced the gold standard for RPs. http://www.cogent-ssc.com/general/news/13_05_14_Responsible_Person_RP_A_new_Gold_Standard_in_Medicinal_Products.php Talking of this development, Mark Birse, Group Manager GMDP Inspections at MHRA commented “Responsible Persons play a vital part in ensuring the quality and the integrity of medicinal products are maintained throughout the distribution chain. It’s essential that they have the right knowledge,…

2
Apr 14

Have you subscribed to the MHRA email alerting service? Any and all staff involved in GDP related activities should take advantage of this free and essential resource. https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency/email-signup Whether you are involved in Good Distribution Practice, Good Manufacturing Practice, Pharmacy or just like to keep up to date with the news. How can this help…

With the updates to EU GDP last year many small pharmacy wholesale operations are still catching up and coming to terms with the impact that it has on their business, but is there a bigger problem ahead? For years pharmacies have been audited by the RPSGB and now the GPhC, yet how many are still…

How do the MHRA carry out inspections? Those of us who have been lucky enough to attend more than a few know that it can vary slightly, depending on which inspector is leading. Although the framework remains the same, some inspectors may have particular areas of interest or expertise which can then colour the inspection…

Many companies are unable to provide their own Responsible Person and turn to a Contract Responsible Person to help manage and support their GDP Quality management system. When selecting your Contract Responsible Person, how should you go about it? Opinions vary, but many will pick a person they know, or is known by a trusted friend…

We are often asked for assistance pre-inspection, and to help prepare a site in advance of the regulator’s visit. How can we help you to help yourself? If you don’t want to engage us to assist directly, then we recommend; read our free and helpful blogs. Check your compliance against the EU GDP Guidance update of November…

An MHRA (other competent authorities are available!) Wholesale Distribution Authorisation (for medicines for human use) aka WDA(H) is the revised name for the MHRA “wholesale dealers licence” which is the licence issued by the MHRA (Medicines and Healthcare Products Regulatory Agency) to wholesalers. If we don’t seem to be able to make up our mind re what it…

Paradigm Shift Consulting are a third-party provider of the PharmaDoctor suite of services. Whether you are looking to provide travel health solutions, from anti-malarials to yellow fever vaccinations, we can arrange full training and marketing support to get your clinic up and running, and to become a success. Want to provide Erectile Dysfunction, Hair Loss,…

The new guidance for Good Distribution Practice was published March 7th 2013, and came into law in September 2013. Some of the updated guidance and legislation will potentially leave you at risk of major or critical failings in your next inspection, if you don’t catch up. Significant changes are noted around the following areas; 1)…

Firstly… what is an RP? Aside from Responsible Pharmacist, and Role Play, in the environs of wholesale and GDP (Good Distribution Practice, NOT Gross Domestic Product!) the letters RP stand for “Responsible Person.” So… what is a Contract RP? Not all holders of a WDA(H) (Wholesale Dealers Authorisation for medicines of human use) will either…

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Feb 14

Discount Specials

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Paradigm are proudly partnered with Discount Specials, a provider of quality unlicensed medicines. Discount Specials supply quickly, efficiently, and cost effectively, avoiding the dubious “rebate” model that some companies have been shown to be using. How does it work? We set you up a new account, and you order online or by placing a call. Tariff…

Paradigm Shift Consulting Ltd, and Smartway Pharmaceuticals have, on request, been given a deal for their customer bases on the newly published MHRA Green Guide – Rules and guidance for Pharmaceutical Distributors 2014 The MHRA and Pharmaceutical Press have kindly agreed to extend their FREE DELIVERY offer on the Green Guide – offer now extended to…

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Jul 13

PharmaDoctor Update

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The PharmaDoctor PGDs are now on offer at 3 for £99, with each PGD thereafter for £19, per pharmacist OR nurse. Oral PGDs are still available at the low price of £45 each, or completely free to sign up to on the Pay-per-consult offering. You pay just £5 per SUCCESFUL consulation, capping at a maximum…

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Apr 13

PharmaDoctor

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Paradigm Shift are now working in conjunction with PharmaDoctor, a new entrant into the private PGD market. PharmaDoctor also provide an online GP solution, flu vaccination, a wide selection of oral PGDs and travel clinic accreditation. Whether you want to provide Propecia, Viagra or flu jabs, PharmaDoctor have a solution for you. Speak to us…