Author: Paradigm Shift Consulting

  In November 2017, the MHRA released a document that contained deficiency data from inspections carried out in 2016. It included the most common areas of deficiencies found during inspections in relation to the GDP EU Guidance 2013/C 343/01, as well as examples of deficiencies from each chapter.  The data showed that the top deficiency areas…

Since the approval for specialist prescribers to write scripts for CBPMs (Cannabis based medicinal products) was given for 01 Nov 2019, there has been a flurry of activity to get licensed. Paradigm Shift have had multiple enquiries about licensing for the procurement and supply of CBPMs, and are working with a number of companies in…

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…

Holders of a Wholesale Distribution Authorisation (Wholesale Dealer Authorisation) 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 many customers who have experienced MHRA regulatory action resulting in suspension of the licence and being listed on the public MHRA Suspended…

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,…

  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…

Just a tiny refresher… are you approving suppliers and customers appropriately? We posted about this topic before, as it is business and licence critical. Bona Fides (Approval of Suppliers and Customers) Checks – how and why? Suppliers and customers are on either side of you in the supply chain, and if you supply someone who…

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…

Many wholesalers have been found to be deficient during their GDP MHRA inspections, especially with their Chapter 30 Commodity codes, when exporting pharmaceutical products. Many have exported pharmaceutical products either using a “blanket” code that they believe suits finished products, or in some cases not even coding their products at all. In some circles the…

  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…

Well, it has been a long time coming, but the Home Office have now re-posted the list of controlled substances which has been down for over a year.   https://www.gov.uk/government/publications/controlled-drugs-list–2/list-of-most-commonly-encountered-drugs-currently-controlled-under-the-misuse-of-drugs-legislation   This list shows drug classifications as well as schedules, and although not exhaustive is a useful tool. To supply controlled drugs a site needs…

Do you supply medicines as stock to other healthcare providers or other legal entities by way of wholesale dealing? You may be aware you need to hold a Wholesale Distribution Authorisation or WDA (H) if you supply medicines as stock to another legal entity, but do you supply Controlled Drugs (CD) too? If yes, you…

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…

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…

For those who do not already know, the “5% rule” for pharmacies disappeared some time ago and to purchase products from a site without a WDA (Wholesale Distribution Authorisation) is a critical deficiency in Good Distribution Practice. Prior to 14 August 2012, section 10(7) of the Medicines Act 1968 provided a pharmacist in a registered pharmacy (or…

What is Pharmacovigilance? By Joan Mwanaka, BSc Did you know that every drug has a side effect? It has been reported that a drug without a side effect will not work! So, if drugs are supposedly causing side effects, why are they on the market, and how are these drugs monitored? Pharmacovigilance is the answer…

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…

Yesterday the MHRA released their first two blogs; https://mhrainspectorate.blog.gov.uk/2015/06/23/welcome/ https://mhrainspectorate.blog.gov.uk/2015/06/23/join-our-talented-and-dynamic-team-protecting-public-health/ Written by Mark Birse, Group Manager for the MHRA Inspectorate, the first blog covers the plan to bring blogs from all areas of GxP, including; – Compliance management approaches – Data integrity – Preventing drug shortages – Significant findings from our inspections – Supporting innovation…

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?…

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…

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…

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 “New” GDP guidelines now having been in effect since September 2013, and the requirement for registration of brokers of pharmaceutical products the Paradigm team are quite surprised at how few brokers are registered. At last check (4th Feb 2015) count there are only seventeen/17 pharmaceutical brokers registered, whether as companies or individuals. Why…

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…

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Jan 15

The MHRA website originally sat on the domain www.mhra.gov.gsi.uk but was moved recently to www.mhra.gov.uk Aside from breaking lots of our web links much content was archived, and the new site is “light” on content. Many of the links that still sit on Google will take you to the archive, which is a snapshot of…

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 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…

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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 Wholesale Distribution Authorisation for medicines for human use (WDA(H)). Use of the MHRA Portal has made the job significantly easier, as it allows you to save your work and return if you…

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…

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…

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 Quality Management System (QMS). So… what makes a good set of Wholesale…

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…

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