The NIMR-MMRC Pharmacy Department provides pharmaceutical care and research support to patients/volunteers and investigators. It assists NIMR-MMRC clinical staff to conduct clinical trials, assuring compliance with the protocols and GCP/ICH guidelines by collecting, recording and maintaining data and source documents and storage of the investigational medicinal products at specified conditions.
NIMR-MMRC Pharmacy is situated at the ground floor of the NIMR-MMRC main building. It contains Pharmacist's office, Pharmacy Preparation/ Storage room and a vaccination room all laid out adjacently to one another in a manner that permits smooth workflow and at the same time maintaining quality standards that are required by Regulatory Authorities within and outside the country.
At NIMR-MMRC we pay great deal of attention on how we store the investigational products, this ensures we administer product of the proper quality to avoid discrepancies in study results and any harm to participants. We provide a secure monitored storage for all investigational products according to the specifications outlined in investigator's brochure or the protocol.
Investigational product can be stored in any of the three places according to specifications:
- A vaccine refrigerator, maintained at a temperature of 2º to 8ºC
- A freezer maintained between -10 to - 80º C or according to Manufacture's instructions.
- A drug cabinet for medications stored at room temperature.
Storage refrigerators, freezers, cabinet and/or room have temperature graphs and temperature logs.
They are all connected to a remote alarm system. They are protected from power fluctuations and power failure by UPS and back-up generator.The pharmacy room it self is kept at 25°C and not exceeding 60% RH
All pharmacy equipments are validated regularly for proper functioning.
Since the reconstitution or preparation of investigational product requires clean environment we have equipped our pharmacy with a class II Bio safety cabinet which is also regularly serviced by a qualified technician.
Records for day to day activities are kept in the file as well as pharmacy computer. Records such as
- Vaccine preparation
- Dispensing records
- Shipment records
- Temperature logs
- Patient/volunteer randomization, just to mention a few are well kept in steel cabinet which is also fireproof in the pharmacy.