Category: Paradigm Updates

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

Starting in February (2019) we are extending the duration of our training courses so that they will now run for two days instead of one. Day One will be an intensive session that covers all chapters of the EU Guidance, expectations of the MHRA, bona fides, deviations, CAPA, Change Control and Complaints. This is an…

  The question is often asked “What temperature should 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 majority…

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 (May 2016), and when the MHRA carry…

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, legitimate, lawful, valid, unadulterated, legal 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…

  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….

In essence, we are a service to the pharmacy and wholesale sectors specialising in streamlining operations and increasing profitability. We have many satisfied customers who have used our service to take advantage of innovations in a quickly developing pharmacy market. Whether this is setting up assisting in managing a Wholesale Distribution Authorisation, implementing private PGDs, travel…

  Cogent SSC have officially announced the gold standard for RPs. 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, demonstrate…

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…

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…

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/updates are noted around the following areas; 1)…

Firstly… what is an RP? In terms 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 be capable, or desire, to be the Responsible…

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Feb 14

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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