How the standard is held
The value of a distributor in this market is whether the conditions a product needs are actually maintained, and whether that can be evidenced afterwards. These are the systems we operate.
Registration and lifecycle
We prepare registration dossiers, submit them to the Syrian Ministry of Health, and maintain the file through variations and renewals for as long as the product is marketed. Communication with the authority runs through our regulatory team rather than through third parties.
Artwork and labelling are checked against national requirements before print. Import authorisations are prepared in step with the registration so that clearance does not become the bottleneck.
Conditions maintained from arrival to delivery
Our storage and transport operations are run under Good Distribution Practice.
- Temperature control
- Storage areas are temperature controlled and monitored, with mapping used to establish that conditions hold across the whole space rather than at a single sensor.
- Cold chain
- Cold chain products are held and moved in qualified equipment, with temperature recorded through transport and reviewed on arrival.
- Quarantine and segregation
- Incoming stock is quarantined until released. Rejected, recalled, returned and expired stock is segregated and controlled separately.
- Stock rotation
- Stock moves on a first expired, first out basis, with shelf life monitored and reported.
- Traceability
- Batch records allow a consignment to be traced from arrival in the country through to the customer that received it.
- Recall readiness
- Recall procedures are documented and rehearsed so that a batch can be located and withdrawn without waiting for a process to be invented.
The warehouse itself
Receipt and inspection procedures check quantity, condition and documentation before stock is accepted. Access to storage areas is controlled and recorded.
Cleaning, hygiene and pest control are scheduled and documented rather than done on request, and storage layout keeps product types separated in line with their handling requirements.
The system behind the practice
- Standard operating procedures
- Operations run to written procedures that are version controlled and reviewed.
- Training records
- Staff are trained against the procedures relevant to their role, and the training is recorded.
- Deviations and CAPA
- Departures from procedure are recorded, investigated, and closed with corrective and preventive action.
- Self-inspection
- Internal audits are scheduled, and findings are tracked to closure.
- Complaint handling
- Product complaints are logged, investigated and forwarded to the marketing authorisation holder.
Adverse events and product complaints
Reports reaching any of our channels are recorded and forwarded to the marketing authorisation holder within the applicable timelines. A dedicated address is published so that reports are not lost in general correspondence.
Auditing a potential partner?
We are glad to walk through our procedures, records and facilities with a principal's quality team.