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Drug Stores & Distributors

Naratech consulting services for pharmaceutical drug stores and distributors

Naratech Pharmaceutical Consultancy offers the following consulting services to drugstores/wholesalers, logistics companies, distributors and shippers:

1. Gap assessment and pre-inspections of facilities, utilities, personnel, equipment, and quality/work systems

2. Quality system establishment and improvement in accordance with current FDA/EU/WHO/ HC regulations, which include:

  • Good Storage and Distribution Practices (GSDP)
  • Good Documentation Practices (GDP)
  • Good Transportation Practices (GTP)
  • Good Shipping Practices (GSP)
  • Good Pharmacovigilance Pratices (GVP)

3. Establish or improve a handling system in compliance with applicable FDA, EU, WHO, and HC regulations for time and temperature sensitive products (TTSP), including:

  • Good Cold Chain Management Practices
  • Good Vaccine Management System

4. Regulatory Affairs Issues:

  • Prepare and evaluate registration files in accordance with current CTD format requirements.
  • Support on regulatory issues and follow-up with regulators and contracting authorities.

5. Review the design of storage facilities and make changes to comply with current regulations:

  • Design review and modification of storage facilities to meet various product status classifications, especially those with limited access
  • Security measures assessment
  • Temperature/humidity mapping, shelving and loading configuration recommendations
  • Storage conditions zones determination

6. Qualification/ mapping/ verification for:

  • Cold rooms, fridges and freezers
  • Transportation vehicles and ice bags
  • Warehouses

7. Establishment of a working system and documentation as follows:

  • Revising of the current applied system
  • Establishing the required work SOPs in accordance with the current GSDP
  • Determining the right communication channels between different departments
  • Defining responsibilities with clear tasks
  1. Personal selection, evaluation and training

  2. Organogram and job description creation

  3. Continuous Auditing Program