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Interim Responsible Person (RP) Services

PCS offers interim Responsible Persons for product release in the EU.

Used by

Abbott
Roche
Pfizer

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Why you should contract a PCS interim RP

  • Hiring a Responsible Person is a time consuming process,
  • Contracts are flexible and you only pay for hours worked,
  • Finding a suitably qualified and trained RP is challenging,
  • Our Responsible Persons are highly experienced.

Let's find you a Responsible Person!

We will quickly find a suitable and qualified RP for you! We usually respond within the hour. With more than 30 years of experience in the pharmaceutical industry and logistics, we have a wide network of interim RPs for both small and large companies.

What is a Responsible Person?

The Responsible Person, abbreviated as RP, is mandated by the EU GDP regulations. The Responsible Person is legally responsible for most Quality affairs within the company.

These responsibilities include; maintaining the Quality Management System, performing recalls, ensuring staff is trained and deciding on the fate of returned products (amongst others).

The Responsible Person is contracted or employed by the wholesaler (WDA). Although there is a financial relationship, the Responsible Person is independent. Decisions on releasing products from the warehouse, return or quarantine should not be corrupted by commercial motives.

How can I contract an interim Responsible Person?

The first step is to get in touch with us. Go to our contact page to submit a request. You can also use the form below to submit a request.

After you have submitted your request, we will plan a telephone conference to discuss your needs in detail.

After the call we will explore our immediate network of consultants to find you the right Responsible Person. We will organize a meet & greet with each candidate to see if there's a match.

When there's a match in terms of experience and personality we will send you an offer. Once the offer is approved the RP needs to be trained on your products and procedures. Simultaneously we will start working to add the Responsible Person on your wholesale license. As soon as the Responsible Person has been added to your license, he/she can assume responsibility over your products and quality system.

Jaap Koster, CEO of PCS, avatar

A Responsible Person in GDP stands as the guardian of quality, ensuring the integrity and safety of pharmaceuticals throughout the distribution chain. In this capacity, having an independent and experienced RP is crucial.

Eng. J.J.M. Koster
CEO of PCS

Can anyone become a Responsible Person?

With sufficient experience and formal training you are allowed to be a Responsible Person. The GDP lists a few requirements to become a Responsible Person:

  1. A degree in pharmacy is desirable,

  2. The Responsible Person should have appropriate competence and experience as well as knowledge of- and training in GDP,

  3. The Responsible Person should fulfil their responsibilities personally and should be continuously contactable.

  4. The Responsible Person shall reside in the European Union.

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Frequently asked questions

How long does it take PCS to find me a Responsible Person?

On average, we need about two to three weeks to find you any number of candidates; depending on the complexity of your product and supply chain. Some countries in the European Union have local regulations that differ from the EU guidelines. An example of this is Spain - where an RP needs to be a QP. Or Romania - where RP's need to be fulltime employees. However, in most Northern European countries there are no special provisions, and in most cases - an RP should be found within the aformentioned timeframe.

How does your fee structure work for interim Responsible Persons?

We charge an hourly fee for the interim Responsible Person, plus travel costs (if any). Every RP is different, and so is their level of experience. Different RP's have different hourly rates. You only pay for hours worked, which are invoiced monthly. We always agree on a maximum number of hours in each contract, deviations, however might be necessary when mandatory GDP tasks or responsibilities need to be performed such as a recall for example.

What happens when my interim RP gets sick or is unable to perform the duties, will PCS provide a replacement?

Yes. PCS provides free replacement of the interim Responsible Person. We will find the most suitable candidate and propose this candidate Responsible Person to you. If possible, the old RP will perform the transfer of tasks & responsibilities. If the old RP is incapacitated, we will find a suitable solution free of charge.

How many hours does a contract RP need per month?

The number of hours an interim Responsible Person needs differs for every company. In some cases, the RP needs no more than 16 hours per month, in others the RP may need 50 hours per month. The recommended minimum is twelve hours per month to allow the Responsible Person to fulfill the required GDP tasks and responsibilities.

Let's find you a Responsible Person!

We are a pharmaceutical consultancy dedicated to quality and patient safety. Are you looking for a __Responsible Person__ or other interim staff? We have the expertise and network to provide you with highly responsible candidates. Feel free to contact us if you have any questions about our Responsible Person services or GDP in general.

  • Hiring a Responsible Person is a time consuming process,
  • Contracts are flexible and you only pay for hours worked,
  • Finding a suitably qualified and trained RP is challenging,
  • Our Responsible Persons are highly experienced.