Safeguarding Products and Users
The term Responsible Person (RP) is defined by a 2001 EU Directive and it is a requirement that an HPRA Wholesale License Holder has such a person on their team our RP is responsible for safeguarding products and product users against potential hazards arising from poor distribution practices. That role involves on site signing and approving all SOPs in relation to Pharmaceutical clients. Responsible Person is responsible for ensuring compliance with current Good Distribution Practice (cGDP) Requirements, including, but not limited to documentation control and all stages of storage and distribution.
Our RP works in tandem with the QC Manager/Quality Analyst to ensure that:
- Store-All’s Quality System consistently meets current GDP requirements.
- Store-All’s Quality System is updated and maintained on an on-going basis.
- Store-All’s operations are covered by the Quality System in all aspects.
Key facets of our Pharmaceutical & Health Care Quality Systems include: