Category: Industry

The mention of the IAG can strike fear into the hearts of many wholesalers… usually those who are not compliant with GDP. So, who are the IAG? The letters IAG stand for “Inspection Action Group” and they’re a multidisciplinary team that are part of the MHRA. IAG 1, responsible for GDP, GMP and blood banks meets…

A new role was announced at the MHRA GDP Symposia in London, yesterday. Cheryl Blake’s presentation “Preparing for a Changing World” included information and potential scenarios post Brexit. Within this presentation was information on the new role… the “RPI” The RPI (Responsible Person – Import) will come into being in the coming weeks and months,…

GDP Responsible Person and Management Training    Paradigm Shift Consulting are holding regular Good Distribution Practice training at our organised venue in the midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more. We aim to provide as much value to you and your…

  Quality Risk Management (QRM) should be focused on the quality of the product – the level of detail corresponds with the task in hand. It is a  systematic approach for assessment, control, communication and review of the risks to the quality of the medicinal product is needed. Managing Risks There are often issues, and…

  Paradigm Shift Consulting is holding regular Good Distribution Practice training at our organised venue in the Midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more. We alternate GDP training for RPs and Managers, with audit training and more focused training on CAPA,…

  Paradigm Shift Consulting is holding regular Good Distribution Practice training at our organised venue in the Midlands, covering the 10 critical chapters of the EU Guidelines 2013/C 343/01, including Change Control, CAPA, Deviations, Falsified Medicines and more. We alternate GDP training for RPs and Managers, with audit training and more focused training on CAPA,…

The Medicines and Healthcare products Regulatory Agency (MHRA) are responsible for ensuring the safety and quality of medicines and devices.

Wikipedia (other information sources are available, and recommended) states; Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a…

GDP Training Courses Paradigm are now offering monthly GDP training sessions at their offices in Rushden, Northants, NN10. Training sessions include; 1) GDP Training for Managers and RP Teams, covering the 10 critical chapters of the EU Guidelines for Good Distribution Practice for Medicines for Human use 2013/C 343/01 2) Audit training – A day…

The Falsified Medicines Directive is a key focus for the UK Competent Authority (the MHRA) and it is expected that as a UK Pharmaceutical wholesaler that you are aware of this emerging regulation. The FMD comes into effect 09 Feb 2019, “Brexit” or not. For more information around Falsified Medicines and the coding, see our…

Falsified Medicines   An update on the Falsified Medicines Directive from 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). “With the Falsified Medicines Directive coming (slowly) to fruition, it will be pharmacies and wholesalers bearing the brunt…

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…

Import tax minimisation and planning Import taxes include customs duty and VAT and these represent high costs within international supply chains. They impact EU manufacturers and distributors that source raw materials or finished products from overseas. Even UK/EU suppliers can also be a source of opportunity, should they have previously imported products that are being…

Preparing for your initial or return MHRA GDP inspection? Do you know what you need to do prior to the visit? At Paradigm we prescribe always being inspection/audit ready. Despite being given a two week notice of MHRA inspection it is essential that you remain as up to date as you can at any given…

As many of you will know, manufacturers do NOT need a WDA(H) (Wholesale Distribution Authorisation for medicines for human use) if they are distributing their own products. What many manufacturers do not realise is that they are now operating illegally by procuring, supplying, invoicing etc. UK Manufacturers; Are you conducting wholesaling activities in other countries?…

Brokering and GDP   With the release of new legislation around brokering, do you know what you are doing? Many are still misunderstanding the term “broker” and are brokering illegally, or without knowingly doing so. This post from Senior Associate Bernard Lawlor may help enlighten you. Are you, while acting as a Pharmacist or as…

We see frequently that sites share their wholesale Standard Operating Procedures aka SOPs. This 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 for a different business model or out of date (not following current guidelines). A…

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…

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…

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…

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 due 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…

  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…

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,…

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…

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…

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…

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; – Reading our free and helpful blogs. – Checking your compliance against the EU GDP Guidance update…

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

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