Expert
resources

There are several key roles that require experienced personnel to ensure compliant operation of GDP relevant licence/registration, some of these roles need to be named on the licence/registration itself.

Do I need this?

Key personnel responsible for GDP compliance will be checked and approved by the relevant licensing authority.

Ensuring that the right, experienced personnel are utilised in these roles is key to a successful project and essential for a new licence, or variation to an existing licence.

Often situations require an experienced, trained back-up resource, for either workload sharing and/or absence cover.

Related services.

HTF can provide experienced resources for the key GDP roles.

Responsible Person (RP)

The naming of a suitable Responsible Person (RP) is a legal requirement for a UK WDA(H), a contract RP is often used by WDA(H) holders. HTF has a group of experienced RPs who are available for this service, both for MHRA and HPRA WDA(H).

Responsible Person for Import (RPi)

Post-Brexit, the MHRA introduced a new role of the Responsible Person for import (RPi). This role applies to the supply of product to a UK WDA(H) holder where the product is imported from the EU, purchased from an EU supplier and having been QP released by an EU QP.

Quality Assurance Manager (QAM)

An important part of making sure an RP can function well is having a good Quality Assurance Manager (QAM) taking care of all day-to-day quality activities.

Quality Assurance Administrator (QAA)

A Quality Assurance Administrator (QAA) is used to support a QAM in a larger organisation, often where an in-house QAM is in place but needs some additional help.

Supply Chain Manager (SCM)

Our supply chain team can advise on all aspects of the supply chain and can also be provided as a contract Supply Chain Manager (SCM).

GxP Auditors

Our quality team  have experience in a range of auditing areas, mainly GDP but also some have GMP audit skills. We can conduct one-off or regular audits in a variety of situations, from in-house or contract storage sites to administration sites (QMS only), transport providers and other 3rd parties that you may use.

Decoration

Get in
touch

If you need more detailed information on any of these related services, or advice on which services you do need, please get in touch.

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How we can help.

Whether you need some support for your existing quality team or need HTF to manage the whole of a new licence project, we can provide the expertise and collaborative approach that will result in an on-time and successful project.

Often our project team then continue as key contract resources in the operational aspects that follow.

A process that starts at any point.

No two clients or products are the same and everything we do for a client is bespoke, making use of the wide variety of our team’s previous experiences.

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From an initial meeting, we can often understand in broad terms what is needed and what part we can provide. There is no cost or obligation to use HTF at this stage.

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We help obtain or update a licence

We can manage the project from application through the inspection(s) to the award of the licence(s).

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You have your own team at HTF

Each client has one or more regular HTF personnel working with them, creating a close working relationship. In addition, the knowledge base of the whole team is always available to every client.

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Adapt and evolve our service

As a client’s resources, product portfolio and general situation change, we can adapt our services to suit, providing increased or decreased services as required by you.

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Longstanding relationship built

We often partner with our clients for many years, flexing our services as their situation changes.

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We make any amendments

Licences are regularly varied and expanded, we can manage these as smaller projects.

Case study.

We never divulge confidential details of any client publicly, but here is an anonymised example of a typical resource provision we have in place.

UK WDA holder:
RP/RPi and QAM combination

An existing client of HTF is a small, single product, UK WDA holder using a pre-wholesaler in a light touch supply chain model.

HTF provide a two-person team to operate their UK quality system; an experienced RP/RPi (named on the client WDA) and a QA Manager for the day-to-day activities. The small amount of commercial/supply chain activity that occurs is also covered by this team, enabling the client to focus their employees on the sales, medical and marketing side of the business.

What did we do?

Supply experienced RP/RPi

Supply QAM

Manage UK supply chain

Maintain GDP compliance

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