Qualified Person -release of pharmaceutical batches
“Batch release” is a test of each pharmaceutical batch before release and is required for clinical batches for Phase 3 clinical trials, and for commercial marketing. The QP verifies compliance with the conditions of registration) of the preparation (or specifications for Ph 3 clinical trial material) and legal requirements for GMP production.
This service is performed in close cooperation with the client’s QA representative.
The service is designed to ensure the quality and safety of the pharmaceutical preparation while meeting the latest Ministry of Health regulatory requirements.
QP services include:
● Release batches of medical preparations (existing and new), registered in Israel, for commercial marketing
● Release batches of imported preparations
● Batch release for clinical research, including from pharmacies in hospitals
● Handling batch returns
● Managing the relationship between the client and the Ministry of Health in all matters relating to ISO, GLP, GDP, and GMP.
● Ongoing quality assurance support, QA tests, quality agreements, and supplier evaluation
The service, described for the medical Cannabis industry, applies to the entire supply chain from the farm to the trading house. The service is designed to ensure client compliance with the requirements of the Dangerous Drugs Ordinance.
Responsible Pharmacist services include:
● Treatment of import permits for cannabis products
● Managing cannabis inventory including factory receipt, storage, transportation, control of inventory counts, discarded material, and destruction
● Drug Book Management
● Production of periodic reports
● Managing the relationship with the district pharmacist in the Ministry of Health
● Regulatory matters in relation to ISO, GLP, GDP, and GMP
● Ongoing quality assurance support QA, tests, quality agreements, and supplier evaluation