Responsible Person Services
I was employed by a start-up pharmaceutical parallel importer back in 2005. They had the premises, and the equipment and product licences bought from a previous parallel importer, but not much else. We had to pretty much start from scratch.
It was imperative to get the right personnel in the right positions. We started with a skeleton crew – a Responsible Person (RP), a Qualified Person (QP), a Production Manager, a Regulatory Manager and a Purchasing Manager.
We all worked together to get the premises, the Standard Operating Procedures (SOPs) and documentation, etc. all in place ready for our MHRA inspection. Without a Wholesale Dealer Authorisation (WDA)/Manufacturers Licence (MIA) we were unable to do anything.
I was part of an experienced and knowledgeable team, who had been in the industry for many years. They knew what had to be done, and how to do it properly and so it didn’t take long for the authorisations to be granted so that we could start trading.
As with any small company trying to grow, we all had many job titles to go with the many jobs that had to be done. As a result, my training was extensive. I was trained in warehouse duties – goods in and dispatch, in production – from producing the labelling and leaflets to repackaging stock, in quality – checking imported and finished products, and regulatory – applying for and maintaining product licences.
I grew with the company and helped worked through the teething problems that were experienced. But I also saw the many successes that were made as we overcame those problems. The bigger the company became, the more staff were employed, the greater our knowledge and expertise grew.
Why a Responsible Person?
I wanted to pass on and instil in others the knowledge and expertise that I’d obtained over the years, and to share my experiences.
I want to help and guide others to avoid the common mistakes and teach them how to overcome obstacles.
I also want to be able to sleep at night and help others to do the same knowing that we’ve all done things properly and safely, and that patient safety hasn’t been compromised.
So why choose MODUS?
I started MODUS with a colleague of mine as we shared the same goals and values.
To consolidate the knowledge we’ve acquired over the years, we completed an RP course - specifically the Cogent Skills RP Gold Standard course recognised by the MHRA.
A Responsible Person has many duties and obligations which can be found here.
It’s our job to keep you compliant, to ensure product safety and quality is maintained throughout the storage and distribution process, and to ensure you have a good and suitable Quality Management System (QMS) in place.
We want you to know that we pride ourselves on staying up to date and current with the latest procedures and regulations. We want you to be confident that you know you are working with trustworthy and competent professionals.
We can help you with any or all aspects of the WDA requirements. We will help you ensure that Good Distribution Practice (GDP) guidelines are complied with, ensure you have a suitable QMS in place and that your SOPs are current and fit for purpose.
All WDA holders need an RP on their licence, however, the RP doesn’t have to be employed by the company so you can use a contract RP if you want. You can also have more than one on your licence as RPs need to be contactable 24/7 in-case of recalls. MODUS is ideal for this as we are both trained RPs, so you essentially get two RPs for the price of one. But it just all depends on what you need. Sometimes you don’t need a full-time, employed RP on site, a part-time contract RP might be more suitable.
However big or small your needs are, or if you’re just not sure, give us a call or email to see how we can help you.
We look forward to hearing from you soon.