Pharmaceutical Electronic Stability Testing Analysis and Reporting -
eSTAR - Manages Stability Testing, Data Analysis and Reporting
As various pharmaceutical companies with hard working scientists in various fields working towards finding a perfect vaccine for COVID-19, it is as important to study the stability of these vaccines to estimate the effectiveness of the available vaccine for the duration of effectiveness, simultaneously.
STABILITY of the VACCINES -
Important aspects of Stability of Vaccines during all stages of development and is easily recorded and analyzed in the
EAPHARMICS eSTAR Pharmaceutical Stability Software.
From early stages of development to final stages of stability report, Stability is simplified in the eSTAR application with Secure, Reliable and Accurate Stability Software Application.
Key Aspects of Vaccine Stability:
.
Vaccine Stability study Design,
Vaccine Stability in different climate conditions:
Climate Zone I:
Temperate
Climate Zone II:
Mediterranean, Subtropical
Climate Zone III:
Hot, Dry
Climate Zone IV:
Hot, Humid
Stability evaluation at different stages of production and use,
Stability indicating parameters,
Stability frequency testing,
Cumulative age of an antigen and effectiveness of Vaccine,
Stability studies for clinical trial,
Stability evaluation for during and after licensing,
Stability testing including assays for lot release,
Stability Test Results,
Stability Data Analyses and Evaluation including Statistical Analysis,
Stability studies and analysis of the data to support manufacturing changes, and
Data analysis Stability evaluation of combined vaccines.
Temperate
Mediterranean, Subtropical
Quality labeling is important for vaccine storing objects and should adhere to compliance authorities (Such as United States Food Drug Administration-USFDA, Therapeutic Products Programme-TPP, International Conference on Harmonisation-ICH, Therapeutic Goods Administration-TGA, National Institute of Health Sciences - NIHS and European Medicines Agency EMA of European Union EU and other agencies) requirements.
Important details including expiry date should be clearly detailed in the label.
Sensitivity of vaccine to environmental factors (Light and Temperature effects) and recommended preventive measures details should be added in Labels.
EAPHARMICS also provides complete Data Governance and Regulatory Compliance for Pharmaceutical Industry.
EAPHARMICS wishes all pharmaceutical companies to produce a speedy stable Vaccine against Covid-19 and provides support for the stability software needs for the vaccines.
No comments:
Post a Comment