Rivka Slonim Office has extensive experience in providing outsourced Qualified Person (QP) services, as required by the Ministry of Health’s guidelines in light of the European Union’s Mutual Recognition Agreement. In addition to the Good Manufacturing Practice (GMP) guidelines, companies must also adhere to the Good Distribution Practice (GDP) guidelines.
Our office offers the option to outsource the whole range of QP services:
- Establishment of the required quality systems necessary to gain a manufacturer importer licence.
- Managing quality processes for continuous batch release.
- Investigating deviations and implementing corrective and preventative actions (CAPA).
- Managing complaints
- Preparing quality agreements with suppliers.
- Conducting supplier audits, both in Israel and abroad
- Monitoring storage facility and courier service adherence to GDP.
- Preparation for MoH, customer and supplier inspections as well as inspections from customers and suppliers.
- Management reviews
- Auditing international manufacturing plants abroad