External Responsible Persons are Filling Gaps

External Responsible Persons are Filling Gaps

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According to the European Union and Swiss pharmaceutical regulation, no batch of medicinal product can be released for sale or supply without the approval of a Responsible Person RP (Qualified Person (QP) used synonymously to RP).

Who is a RP?
The RP directly supervises the processes of the company and, in particular, ensures that the medicinal products released to the market comply with the valid specifications and are produced in accordance with the rules of Good Manufacturing Practice (GMP).

Why does Morgan Sindall also offer RP services?
Because the purpose of our business is to fully support life science companies to bring innovative medical products to patients. This is why Morgan Sindall offers services ranging from engineering and qualification of modern biotech facilities to the release of the product to the market by experienced RPs.

What are the advantages of outsourced RPs?
Outsourced RPs or RP deputies provide flexibility to Pharma companies to remove capacity bottlenecks that arise due to the varying workload in quality control. External personnel save costs for small mandates and also time by acquiring the required RPs on short notice. In addition, temporary RPs may fill gaps when  RP personnel is already 100% booked or processing already as much as 5 mandates (maximum allowed by the new Swiss regulations since July 2017).

What changed this year for RPs?
In order to gain better level of safety and quality, the Swiss authorities published on the 1st of July 2017 a new version of the technical interpretation, which defines restricted requirements for a Responsible Person in regard to GMP and GDP experience, residence, number of mandates, minimal presence on site and language (I-SMI.TI.17). The scope of this document is to enable to fulfill his/her duties sufficiently to supervise the company’s processes.

According the new requirements, a RP:

  • Should work at least half a day per week within the company (exceptions need to be justified)
  • Should not have more than five mandates at the same time and should not be engaged for more than 100% in total (has to be indicated in an additional form G in the course of the application)
  • Should live less than 2 hours travelling time away from the company’s site
  • Should understand the language spoken in the part of Switzerland where the company has its site

(Find more information on the homepage of Swissmedic here I-SMI.TI.17e Responsible Person. Responsible Person: requirements)

 

Do you need help? Contact our Responsible Person Service: Qualified-Person@morgansindall.ch

Our experts are there to support you to meet this challenge.

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