TAG is dedicated to meet the globally thermal validation needs of pharmaceutical industry. There’s increased emphasis by regulators on compliance with GMP requirements for controlled temperature storage requirements. TAG has the equipment and experienced professionals to help you achieve compliance in this area
what we can carry out
HVAC QUALIFICATION TESTS
Clause 3.19 of the PIC/S GMP guide states:
“Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored.”
Temperature mapping shall be performed on all storage areas to ensure that all locations are likely to remain within the specified temperature limits over the seasons of the year. Raw material and finished good Warehouses shall be temperature mapped in the empty and full states to determine the temperature distribution and Mean Kinetic temperature (MKT) under extremes of external temperature. The mapping exercise shall be performed both during summer and winter in order to assess worst case scenarios, as extremes of temperature may adversely affect the temperature distribution within the storage area. Power failure study, door opening for some time and more man power presence studies shall be performed in temperature mapping study in order to get the sufficient data
TAG’s qualified team conduct Qualification studies (IQ, OQ & PQ) including Temperature distribution test at empty and full load, alarm verification, power failure test in terms and temperature recovery time. we provide you with highly specialized mapping protocol including technical study, analysis and conclusion in addition to deviation reports (if exist) with its corrective actions and recommendations.
TAG’s qualified team conduct Qualification studies (IQ, OQ & PQ) including Temperature distribution test at empty and full load, alarm verification, power failure test in terms and temperature recovery time. we provide you with highly specialized mapping protocol including technical study, analysis and conclusion in addition to deviation reports (if exist) with its corrective actions and recommendations.
TAG’s qualified team conduct Qualification studies (IQ, OQ & PQ) including Temperature distribution test at empty and full load, alarm verification, power failure test in terms and temperature recovery time, door opening test and overnight stops test. we provide you with highly specialized mapping protocol including technical study, analysis and conclusion in addition to deviation reports (if exist) with its corrective actions and recommendations.
Our engineers are capable of defining your validation requirements from a regulatory perspective and from this they can prepare concise protocols in either TAG format or in a client specific format.
TAG is available to perform Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) of new loads and annual requalification (RQ) of existing loads.
We can generate justification documents for the rotational re-qualification of Autoclave loads. We can also perform upgrades to existing non-compliant autoclaves and subsequently perform Air Detector setups