Challenges of Customer and Supplier Qualifications
by Nimesh Patel
The UK GDP Association Annual Conference brought together experts, innovators and professionals from across the medicines supply chain for two days of insight, discussion, and forward thinking practice. As part of our annual “look back”, we are shining a light on our speakers, their professional journeys, and the themes they explored on stage.
Speaker Spotlight: Nimesh Patel, Paradigm Shift Consulting
Anyone who follows the UK GDP Association on LinkedIn will already be familiar with the work of Nimesh, featured in our “In the Spotlight” series. With a long-standing career supporting wholesalers, manufacturers, and distributors across the UK, Nimesh is known for his practical, operationally grounded approach to Good Distribution Practice (GDP).
As well as being the Treasurer for UK GDP Association, Nimesh is also one of the senior managers at Paradigm Shift Consulting, working with clients to build and maintain resilient Quality Management Systems (QMS) that strengthen regulatory assurance.
Challenges of Customer and Supplier Qualifications
At the 2025 Conference, Nimesh delivered one of the highest-engagement sessions of the programme: “Challenges of Customer and Supplier Qualifications.” The session was both technically rich and practically actionable, offering delegates a clear, structured model for strengthening their qualification process in line with regulatory expectations.
Nimesh opened his session by reinforcing the core GDP principle:
“Qualifying customers and suppliers is fundamental to protecting the medicines supply chain.”
Wholesale distributors have a responsibility to ensure that medicinal products are purchased only from authorised entities and supplied only to those who are permitted by law to receive them. That means no purchasing from pharmacies, and no assumptions that a MHRA licence alone is enough.
Supplier Qualification
Nimesh walked delegates through a comprehensive, multi-layered, due-diligence focused supplier qualification framework that goes far beyond requesting a copy of the MHRA licence and GDP certificate. Key elements included:
Regulatory Checks:
When reviewing a manufacturing or distribution licence, verify the details against the MHRA or EUDRA database, if copies have been received, perform checks of the document to look for falsification, for example, fonts used, colours of logos, layout of documents.
Corporate and operational due diligence:
- Reviewing Companies House data to validate directors, trading history, and cross directorships
- Confirm registered addresses and check for discrepancies
- Checking the company VAT registration
- Reviewing the suppliers website for authenticity, domain ownership, secure hosting, and professional presentation
- Verifying email domains to ensure they match official supplier information
- Conducting credit checks
- Requesting industry references and following up on them
Nimesh emphasised vigilance around spoofed of falsified company details. Any suspicion of fraudulent documentation must be reported to the MHRA immediately, using thebureau@mhra.gov.uk website.
Ongoing Monitoring:
It is not sufficient to perform due diligence checks as a one off exercise, ongoing monitoring is critical:
- Check the quality of products upon delivery
- Ensure deliveries arrive on expected vehicles
- Confirm accuracy of delivery documentation
Finally Nimesh reinforced the importance of supplier validation, ideally supplemented with audits and more frequent risk-based checks. This includes reviewing the MHRA suspended, revoked and terminated licence register and seeking written confirmation of any changes to personnel, business models, or licensed activities. Ensure a Quality Technical Agreement is in place and is enforced.
Customer Qualification
When qualifying customers, Nimesh reiterated that “one size does not fit all”. Customer qualification is not a uniform process. Different customer types require different qualification routes:
Registration Checks:
Additional Due Diligence Checks:
As with supplier qualifications, validation of customers does not stop at checking their registration status, additional checks are required. These checks may include:
- Companies House searches
- Reviewing liability insurance documents
- Requesting utility bills to confirm site addresses
- Requesting supplier references and following up
Nimesh provided a key operational reminder to conference delegates: “Orders should not be accepted from generic or group email accounts. Orders must only come from authorised individuals.”
Requalification of Customers:
Requalification should always follow a risk-based approach, triggered by:
- Changes in personnel
- Updates to licence categories
- Industry press releases
- Complaint or return trends
- Unusual sales patterns
Nimesh also reinforced that suspicious orders must be reported to the MHRA, linking to themes later explored in Cheryl Blakes keynote on Day 2 of the conference. Her case study on “Stephen” whereby a controlled drug order was flagged by a wholesaler which then went on to illustrate how a single suspicious order can reveal a wider, complex network of illicit activity.
Why This Session Mattered
Nimesh’s session stood out for its clarity and practicality. In an environment where regulators continue to emphasise a proactive approach to verification, his message was simple but powerful: qualification is not a tick-box exercise. It is a dynamic, continually evolving responsibility grounded in critical thinking, cross-checking, and professional scepticism.
Delegates left with strengthened confidence and a sharper toolkit, many commenting that the layered approach to due diligence would directly support their GDP compliance strategies.
Looking Ahead
As we reflect on the 2025 conference, Nimesh Patel’s contribution sits among the standout moments. His professional insight, combined with operational examples and a risk-based mindset, aligned perfectly with the conference's overarching theme: Strengthening resilience and trust across the medicine supply chain.
Registering for the 2026 Conference
There are discounted tickets available for UK GDP Association members, members can save £100 when attending both conference days. However, our commitment to low-cost, high-value educational content means that conference tickets will still be the best value whether you chose to join as members or not.
Membership is only £29 +VAT per individual, per year and offers reduced costs on consulting, training and conference tickets. If you buy tickets for both conference days, there is an even greater discount. Costs for non-members is just £224.50 per day, a fraction of the cost of other industry events!
In addition, on the evening of Tuesday 16th June, we will be hosting an evening event of dinner, networking, and even some of Dave’s infamous karaoke, for just £49 +VAT per person. This is a fundraising dinner in aid of the MVA Society.
Please see here for more information on the conference and to book your conference and evening dinner tickets.
We are very much looking forward to seeing you all at the conference!
2025 Conferences
