Year: 2014

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 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,…

For those of you who are not aware EUDRAGMDP is the new, centralised depository for the National Competent Authorities in Europe for manufacturing, import and wholesale distribution authorisations, and GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) certificates. The public version of the EUDRA GMDP database is a useful tool for anyone involved in…

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….

We had learned about the forthcoming gold standard for RPs at the 2013 MHRA GDP and GMP Symposia, and expected the news to break soon after. Cogent SSC, formerly known as the Skills Council, released their “Gold Standard” for RPs at the end of April, and we wrote a short blog related to this. With…

7
Oct 14

With the new version of the wholesale dealer licence (WL, or WDL to many) there is a new way to apply for your WDA(H) aka Wholesale Distribution Authorisation for medicines for human use.  Use of the MHRA Portal has made the job significantly easier, as it allows you to save your work and return if…

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 clinic, care…

Holders of a Wholesale Distribution Authorisation (Wholesale Dealer Authorisation or Wholesale Dealer Licence to many) can be suspended for a number of reasons, but most commonly to regulatory action from the MHRA (Medicines and Healthcare products Regulatory Agency). Paradigm Shift Consulting have worked with numerous sites who have faced MHRA regulatory action landing them on the MHRA Suspended Licence list. We successfully helped all…

  The updated process for WDA(H) applications has been in place for a while now, and Paradigm Shift have assisted a number of customers and friends navigate the new MHRA portal system. How can you navigate the system yourself? It’s easy. When you know how. The MHRA have put a helpful guide online which we…

*Note* This article is NOT about Asda Cherry Soothers, or other children’s dummies being recalled. This is a post on carrying out a dummy recall/mock recall of pharmaceutical products. If your wholesale site has not had an active recall during the course of the year, then the competent authority requires that you carry out a…

A QMS, or Quality Management System, is sometimes defined as; “A system by which an organisation aims to reduce and eventually eliminate nonconformance to specifications, standards, and customer expectations in the most cost effective and efficient manner.” or “A set of co-ordinated activities to direct and control an organisation in order to continually improve the…

The Responsible Person has defined duties and responsibilities. EU Guidance 2013/C 343/01 lists them as follows; • ensuring that a quality management system is implemented and maintained; • focusing on the management of authorised activities and the accuracy and quality of records; • ensuring that initial and continual training programmes are implemented and maintained; • coordinating…

10
Jun 14

What is an SOP? SOP is the acronym for Standard Operating Procedure. For those of you in pharmacy you will be familiar with SOPs, which are the backbone of your business. Wholesale SOPs are much the same, and are the backbone of your QMS aka Quality Management System. So… what makes a good set of…

Need help with your application for an MHRA wholesale dealer authorisation? Not quite sure what to do… or think you know what you are doing, but aren’t 100% sure? Whatever your wants or need are, we are here to help. With experience of setting up and supporting dozens of pharmacy “skimming” sites, export wholesalers and GSL sites, Paradigms team of…

The Gold Standard, Responsible Person Medicinal Products was released in June 2014. The expectations for “Responsible Person Medicinal Products” are as follows; The Human Medicines Regulations require a distributor to designate a Responsible Person(s), named on the applicable licence. Regulation 45 and the EU GDP Guide set out the requirements and the responsibilities. Where the…

  The Inspectorate of the Medicines and Healthcare Products Regulatory Agency may call upon you as part of your usual, and announced, inspection schedule, or upon the receipt of information. Most inspections are announced, but there is talk of unannounced inspections coming into play. These would separate the men (and women) from the boys (and girls)….

  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…

Want GDP Training? Click here to see what we can offer. How much will you pay for your GDP training? £500 per person, for a day? £680, pppd? £850 pppd, including lunch? Don’t forget your VAT addition. And the travel costs… and if you are a pharmacy wholesaler, your locum/backfill. At these prices your GDP…

In the United Kingdom the National Competent Authority is the MHRA, The Medicines Healthcare Products Regulatory Agency, but who regulates the rest of Europe? Answers can be found on the European Medicines Agency website where there is a full list of the National Competent Authorities. Where possible we link you to the English version of the website,…

You may be surprised at the number of enquiries we receive from prospective clients who want to get a WDA (H) (wholesale dealer authorisation for medicines for human use) and start what they think is an “easy” business. Everyone needs drugs, right? A safe investment for the future is medication wholesale? Well, sadly, it’s not…

  We think that £55 + Postage and packing is a fair price for such a critical publication, but not everyone will agree. If you do agree, click the link above and buy it from the Pharmaceutical Press. We meet many who do invest, but there are also many more who cannot or will not…

The European Medicines Agency database of good manufacturing practice and good distribution practice compliance continues to be populated as more sites are inspected. GMP and GDP compliance certificates will be uploaded to the site, and will allow prospective customers or suppliers (or other interested third parties, including competitors) view them at will. What does this…

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…

Most of you will be aware of the classes of deficiency that may be discovered during your risk based inspection, but for those who do not, here is a brief summation Critical deficiency • A “Critical” is deficiency which causes, or leads to a significant risk of causing, a product to be harmful to a…

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…

The MHRA regularly find that self inspections, which are required for GDP compliance, are either not carried out or are insufficient in their scope. The new regulations advise that third party inspections could be considered helpful, but cannot replace self inspection protocols. It is also agreed that the self inspection does not need to be…

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…

The MHRA are still issuing the new WDA(H) to licence holders, and after the next inspection cycle all licences and GDP compliance certificates will be found here; http://eudragmdp.ema.europa.eu/ The site allows you to search by WDA number, address and more. You are now responsible for ensuring that anyone you outsource work to is compliant, and…

What are the costs associated with gaining and retaining your wholesale licence? A lot depends upon your business model, but your average pharmacy stock skimming models costs half for the initial inspection as a “normal” wholesaler, as long as they trade 15% or less of their turnover. Small wholesalers trading in less than £35,000.00 per…

The full day rate for an MHRA Good Distribution Practice inspection is £1936.00 This rate is reduced for wholesalers who only supply GSL (General Sales List) products, or for small wholesaler dealers where wholesaling of licensed products does not exceed 15% or £35,000 of total turnover, but ONLY where the inspector spends less than 3.5…

Well, you should already be… but many are not. The updates came into force in September last year. For those who haven’t yet caught up, or are still not completely sure about what they are doing, we recommend purchasing the Green Guide 2014, Rules and Guidance for Pharmaceutical Distributors. But for those of you who…

There are some companies offering coaching on how to “handle” an MHRA inspector. If you think this is of interest to you then I suggest you STOP and think again. If you have to pay to be coached on handling an inspector/inspection then there is something wrong. These simple, common sense rules will help anyone…

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? 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…

6
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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