The European GDP Guideline of 5 November 2013 requires that wholesale distributors have to appoint a Responsible Person for GDP activity. Taking part of many inspections one of the key area the auditors looking is how the roles and responsibilities of key personnel are formally described, including where duties is delegated in the absence of the Responsible Person.
It is of course depending on many circumstances such as:
- The size of your company – how many staff employed
- Contract RP in use
- The RP is onsite
And so on….
In EC Guidelines (5 November 2013) on Good Distribution Practice of medicinal products for human use, chapter 2: 2.2 RP:
- “The responsible Person may delegate duties but not responsibilities”. – So yes, delegate duties to trained staff as your company grows the jobs and `paperworks` are expanding as well.
- “Ensuring the QMS is implemented and maintained”- RP approves the documentation but do not forget he/she is not (in all times) fully responsible for writing your procedures.
- “Ensuring complaints are dealt with effectively”- Delegated staff should write up the complaint and pass it onto the RP for review and for further necessary corrective actions.
The above only a few example to taking into account. Make sure your Quality System detailing the rules and responsibilities of your key personnel including your RP.
If your RP is contracted, make sure written agreement covering the provision of Responsible Person services and the division of day-to-day responsibilities between the contract giver and acceptor and the frequency of the site visits.
If you need professional help please contact us.