Duties of the Responsible Person

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The Responsible Person has defined duties and responsibilities.

EU Guidance 2013/C 343/01 lists them as follows;

• 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 continual 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 pre-arranged 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

Duties may be delegated to a suitably trained person, however ultimate responsibility remains with the Responsible Person or the licence holder if different.

Unsure if you are knowledgeable enough to be the RP?

Worried that you don’t know how to fulfill these core duties/responsibilities?

Let’s de-mystify each of these 12 requirements of the Responsible Person;

• ensuring that a quality management system is implemented and maintained – if you haven’t signed or reviewed your procedures, you may get a deficiency that the QMS was not implemented.

• focusing on the management of authorised activities and the accuracy and quality of records – the authorised activities of your company are what you have on your WDA… accurate, high quality records will include plenty of good data, evidence of activities ideally made contemporaneously.

• ensuring that initial and continual training programmes are implemented and maintained – staff must be trained and competent before they commence their duties, with refresher courses and extra relevant training… and there should be a training plan in place.

• coordinating and promptly performing any recall operations for medicinal products – you should be signed up to the MHRA drug alerts and if no recall occurs in that year you should carry out a dummy recall.

• ensuring that relevant customer complaints are dealt with effectively – complaints can make or break your business… but what is a complaint? Any customer contact that isn’t an order, RFQ or “How ya doing?” should be considered a potential complaint, preventive action or opportunity to trend. A late delivery is a complaint. “I am not complaining, but…” IS a complaint. Document and trend. Close them out. Keep people’s expectations managed.

• ensuring that suppliers and customers are approved – make sure you are certain that suppliers and customers are genuinely entitled to be involved in pharmaceutical trade or purchase.

• approving any subcontracted activities which may impact on GDP – this can be a challenge, especially when you don’t know how to carry out an activity yourself. Third parties who act on your behalf are the face of your company, and should be audited and their performance reviewed, like any employee.

• ensuring that self-inspections are performed at appropriate regular intervals following a pre-arranged programme and necessary corrective measures are put in place – a comprehensive audit of all GDP activities, probably using the EU GDP Guidelines as a guide, and any deficiencies closed out with the CAPA process.

• keeping appropriate records of any delegated duties – any duties that are carried out on your behalf should be logged. This can be via job description of via the organisation chart, or even a calendar.

• deciding on the final disposition of returned, rejected, recalled or falsified products – as it says, any returned product, recalled or real or suspected falsified medicines are for the RP to decide as to the disposition… quarantine and inform the MHRA via the Yellow Card website, or return to stock? Destroy or contact the MAH?

• approving any returns to saleable stock – as above the RP decides if goods are fit to return to saleable stock. Are goods returned within the right timeframe, (5 days ambient, 1 day chilled) and can be evidenced as being supplied, delivered and returned within GDP conditions?

• ensuring that any additional requirements imposed on certain products by national law are adhered to – one good example is sodium thiopental. There is an EU ban on torture chamber items and drugs that some have failed to be aware of.

  •  Need support or advice navigating the RP puzzle?
  • Read the Gold Standard for RPs?
  • Want RP training or RP refresher training?
  • Need a Contracted RP or Contracted Deputy RP?
  • Had a year of experience buying, selling and handling medicines and want to go on our RP course.

Contact us to discuss bespoke options. We can help.

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