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
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Personal selection, evaluation and training
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Organogram and job description creation
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Continuous Auditing Program
