- Pharmaceutical Consultancy
- Mapping and Transport Validation
- Temperature and Humidity Mapping
Temperature and Humidity Mapping
The mapping exercise identifies potential variations in the environmental conditions in a specific process, storage or transport location that could impact the quality of the medicinal products exposed to that area. The temperature mapping exercise can incorporate installation qualification (IQ), operational qualification (OQ) and/or performance qualification (PQ) depending on the specific client requirements.
The goal of the mapping exercise is to ensure medical product quality will not be impacted for the full shelf life when exposed to those conditions, especially relevant when temperature sensitive pharmaceutical products are handled and stored.
FQS team of experts can help your company assessing the environmental conditions of your process/storage/transport areas including ambient, cold chain and freezers.
FQS offer an onsite service which includes:
- An assessment of the area, highlighting savings efficiencies/compliance gaps where applicable.
- Compilation of a bespoke protocol and report.
- Quality Risk assessment completed to identity location of probes.
- Assess location for ongoing probes and provide justification for their location.
- Ensure area is in compliance with regulatory requirements.
- Execution of the protocol.
- Supply of Report with data in summary, graphical and table format.
- Supply of all calibration certificates with report.
- Recommendations provided
