HTF, through associate company GDP Pharma Services Ltd, has several high quality people available as contract RPs,
all approved by the MHRA. The provision of an RP is a legal
requirement for obtaining a Wholesale Dealer’s Licence
(WL) from the MHRA and the relationship between the company
Directors and the appointed RP is a vital one.
A formal legal contract should
be put in place that defines the relationship between the
contract RP and your company, and satisfies the MHRA.
A suitable RP must have several years experience of the storage
and distribution of pharmaceutical product and current GDP
standards, but does not necessarily have to be a pharmacist
or a Qualified Person (QP).
The role of the RP is to check
and advise on GDP standards within the company whose licence
they are named on, to take part in any batch recalls and advise
on any GDP issues that arise during normal operation.
The RP must have a direct
line to the Managing Director and has to formally conduct
a GDP audit at least annually.
The RP has a legal responsibility to advise the MHRA if things are not being handled according to GDP or corrected in adequate time.
If HTF are handling your WL application process and related
SOPs the contract RP will be involved in this work and therefore
provide a seamless transition from the project of obtaining
your WL to operating with your contract RP. We can of course
provide a contract RP for an existing WL.
If you already have a WL, we can also be used to conduct a one-off GDP audit to assess where your gaps might be. This is often the first step if you are considering having a contract RP.
line Responsible Person
It is becoming more frequent now to have a second RP named on your WL. The MHRA are recommending this for larger companies as this provides back up for holidays, sickness etc. We have experience in providing second line RP's, who can, additionally, act as GDP advisors to your primary in-house RP.
Training for your staff is important on a number of levels. Maintaining industry knowledge is vital for your RP, as is regular training on the more routine aspects of his role, but all staff involved in some way in the GDP process are required to maintain and evidence their training records and know how to deal with changing GDP processes and SOP's, as they happen. Whether you want training for individuals or small groups, in the UK or in Europe, we have experience of providing quality, tailored training to meet your specific needs, at your chosen location.