Pharmour’s Testing Services:
With a long history of leading and funding the projects that led to current best practices such as ISTA 7D, ISTA 7E, ISTA STD-0020, and ISTA STD-0014, the Team at Pharmour are in the best position to advise you on a qualification/validation pathway that is good for you and for global compliance.
Pharmour adheres to industry best practices regarding the principles of qualification/Validation as defined in the Parenteral Drug Association’s (PDA) Technical Report 39 (TR39) which closely aligns with the Center for Drug Evaluation and Research (CDER) Guideline on the Principals of Process Validation. The qualification process consists of the following steps.
•Design Qualification – Laboratory testing that creates confidence that the thermal packaging system is capable of consistently operating within established limits and tolerances.
•Operational Qualification – Laboratory testing that provides documented verification that the thermal packaging system’s performance is effective and reproducible throughout the anticipated operating ranges.
•Performance Qualification – Live field testing that provides documented verification that the thermal packaging system performs as qualified in ‘real-world’ conditions.