Naratech pharmaceutical consultancy provides drug stores /wholesalers, logistics companies, distributors & shippers with the following consultancy services: Gap Assessment & Pre-Inspections on Facilities, Utilities, Personnel, & Equipment & Quality/ Work Systems to Provide a Task Plan for Corrective Actions Needed to Comply with GSDP Standards.Quality System Establishment / Upgrading According to Current FDA/ EU/ WHO/ HC Regulations, Which Includes:
- Good Storage & Distribution Practices (GSDP).
- Good Distribution Practices (GDP).
- Good Transportation Practices (GTP).
- Good Shipping Practices (GSP).
- Good Practices for Handling of Cytotoxic Products.
- Good Practices for Handling of Potent Products.
- Vaccine Handling Practices.
Time & Temperature Sensitive Products (TTSP) Handling System Establishment / Upgrading According to Current FDA / EU / WHO / HC Regulations, Which Includes:
- Good Cold Chain Management Practices.
- Good Vaccine Management System.
Regulatory Affairs Issues:
- Registration files preparation &evaluation according to current CTD format requirements.
- Regulatory issues assistance & follow up with regulatory authorities & principals.
Storage Facilities Design Review & Amendments to Comply to Current Regulations:
- Design review & amendment of storage facilities to include different products status classifications, especially those with limited access.
- Security measures assessment.
- Temperature / Humidity mapping, recommendation on shelving & loading configuration.
- Storage conditions zones determination.
Equipment Sourcing & Selection.
Cold Chain Tools Sourcing & Selection.
Qualification/ Mapping/ Verification for:
- Cold Rooms & Fridges.
- Transportation Vehicles.
- Storage Areas.
Validation of Ice Boxes & Shipping Containers.
Sourcing & Selection of Proper Temperature / Humidity Monitoring & Recording Systems.
Work System Establishment & Documentation:
- Revising of the current applied system.
- Establishing needed work SOPs in compliance with current GSDP.
- Defining the proper communication channels between different departments.
- Defining responsibilities with clear tasks.
Staff Selection, Evaluation & Training.
Organogram & Job Descriptions Establishment.
