Responsible Person for medicinal products for human use
De Jong Pharma Consult as your Responsible Person
Instead of appointing a ‘volunteer’ who takes on Responsible Person responsibilities, in addition to all sorts of other tasks and responsibilities, it is wiser to hire a professional for this.
De Jong Pharma Consult has acted as RP for large multinationals and therefore has the knowledge and experience you need to properly implement the regulations. This way you can focus ‘carefree’ on your business, knowing that the patient and your products are in safe hands.
Responsible Person according to the GDP Guidelines
Guideline 2013/C 343/01 of 5 November 2013 provides mandatory regulation towards Good Distribution Practices for medicinal products for human use.
The guideline prescribes that all wholesalers in medicinal products for human use should have a ‘Responsible Person’ to ensure the implementation of the GDP guidelines.
The responsibilities of the responsible person include:
- ensuring that a quality management system is implemented and maintained;
- focusing on the management of authorised activities and the accuracy and quality of records;
- ensuring that initial and continuous training programmes are implemented and maintained;
- coordinating and promptly performing any recall operations for medicinal products;
- ensuring that relevant customer complaints are dealt with effectively;
- ensuring that suppliers and customers are approved;
- approving any subcontracted activities which may impact on GDP;
- ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
- keeping appropriate records of any delegated duties;
- deciding on the final disposition of returned, rejected, recalled or falsified products;
- approving any returns to saleable stock;
- ensuring that any additional requirements imposed on certain products by national law are adhered to.
Designated Person for Active Pharmaceutical Ingredients for use in medicinal products for human use.
Guideline 2015 / C 95/01 of 19 March 2015 prescribes mandatory measures for Good Distribution Practices for active substances for Medicinal Products for human use.
The guideline stipulates that all distributors of active pharmaceutical ingredients used in medicines for human use, must have a ‘designated person’ in order to secure the implementation of the GDP guidelines.
The guideline gives little detail of what this Designated Person should be able to do and what the responsibilities are, only a general text is available.
That is why it is all the more important to bring in an experienced professional to make and keep your quality system compliant. De Jong Pharma Consult has extensive experience and is therefore your partner in a secure supply chain.