QUALIFICATION,VALIDATION

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Qualiﬁcation, Validation & Temperature/RH Mapping

Zonetechs specializes in providing comprehensive Qualification, Validation, and Temperature/Relative

Humidity (RH) Mapping services, ensuring that storage and operational areas adhere to regulatory requirements for temperature and humidity control. Our expert team supports clients in various industries to maintain compliance with critical guidelines, including GMP, GSDP, and international standards.

Our Expertise Includes:

Comprehensive Assessments & Gap Analysis

Development of Tailored Qualification & Validation Protocols

Risk Assessments for Optimal Probe Placement

Detailed Execution of Mapping Protocols

Delivery of In-Depth Reports

Recommendations for Corrective Actions

Industries Served:

Pharmaceuticals: Ensuring compliance with stringent regulatory require- ments for the storage and distribution of temperature-sensitive drugs.
Biotechnology: Maintaining controlled environments for sensitive biologi- cal materials and
Healthcare: Providing temperature and humidity mapping for medical facilities, ensuring proper storage of medications and vaccines.
Veterinary: Supporting the proper storage and transportation of veterinary products to maintain their
Storage and Distribution Facilities: Offering consultation and validation for third-party logistics companies to ensure that the storage and transport of various products meet required environmental conditions.

With Zonetechs’ Qualification, Validation, and Temperature/RH Mapping services, you can be confident that your facilities and operations comply with the highests tandards of regulatory excellence, ensuring the safety and efficacy of your products.

Mapping and Qualification Services For:

After the completion of mapping/qualification we ensure that:

All protocols and reports are overseen reviewed by a Qualified
Advice given to mitigate failure and consultancy available if mapping
Using our k ledge of both ions and temperature monitoring equipment and product requirements we ensure all protocols and reports are reviewed in lic with islation and guidelines for control and monitoring of storage and transportation 1p itions for dicinal products.

What makes Zonetechs different ?

apping protocol and reports compiled and executed by trained
Mapping system used is a validated system and in compliance with Annex
Prior to initiating mapping, the mapping probes are checked against a calibrated probe certified to a traceable international standard.
External conditions are monitored during mapping to ensure that the mapping study is reflective of the season/extremes etc.
Zonetechs carry out a risk assessment of the area to determine the location and the number of probe required to map the area.
Justification provided for number of probes and location of mapping
Results reviewed and justification provided for location of ongoing monitoring
All probes are calibrated to cover the range required and traceable to an international standard

Qualiﬁcation, Validation & Temperature/RH Mapping

Our Expertise Includes:

Comprehensive Assessments & Gap Analysis

Development of Tailored Qualification & Validation Protocols

Risk Assessments for Optimal Probe Placement

Detailed Execution of Mapping Protocols

Delivery of In-Depth Reports

Recommendations for Corrective Actions

Industries Served:

Mapping and Qualification Services For:

Warehouse & Storage Areas

Production Areas

Incubators Cabinets

Cold Rooms/ Fridges/ Freezers

Pharmacies

Veterinary

Clinic

Transport Vehicles /Containers / Reefers

Hospital

After the completion of mapping/qualification we ensure that:

What makes Zonetechs different ?

Qualiﬁcation, Validation & Temperature/RH Mapping