Contract Qualified/ Responsible Person

Qualified Person (QP)

Holders of manufacturing authorisations must have the services of a Qualified Person at their disposal at all times. The QP is responsible to ensure that each batch of medicinal products has been manufactured and checked in compliance with Good Manufacturing Standards and in accordance with the requirements of the marketing authorization (Directive 2001/83/EC). A QP is also needed and is responsible to ensure that each production batch has undergone a full qualitative and quantitative analysis, in the importing Member State in the case of medicinal products coming from third countries.

We offer contract QP services for manufacturing authorisations as well as batch release. Our highly experienced team of qualified persons operate in line with strict EUcGMP guidelines and are available 24 hours 7 days a week.

Qualified Person

Responsible Person (RP)

In order to obtain a Wholesale Dealer’s Licence, the wholesale distributor must designate a person as a Responsible Person. The Responsible Person should meet the qualifications and all conditions provided for by the legislation of the Member State concerned. A degree in pharmacy is desirable. The Responsible Person should have appropriate competence and experience as well as knowledge of and training in GDP.

We can handle your Wholesale Dealer’s Licence application or intervene at any step of the process, from creation of related SOPs, to providing contract RP services, thus providing a seamless transition from start to finish. Pharmaconsulta can of course provide a contract RP for an existing Wholesale Dealer’s Licence.

If you already have a wholesaler, you may engage us to perform a one-off GDP audit to assess where your deficiencies may be. This is often the first step if you are considering contracting an RP.

Second line Responsible Person

It is now becoming more frequent to have a second RP named on your Wholesale Dealer’s Licence. The MHRA in the UK are recommending this for larger companies as this provides a backup for leave, holidays, sickness etc. Pharmaconsulta has experience in providing second line RP’s, who can, additionally, act as GDP advisors to your primary in-house RP.