Drug Stores & Distributors

Naratech Consultancy Services to Pharmaceutical Drug Stores & Distributors

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.

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