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ABSTRACT
In the pharmaceutical industry, ongoing stability monitoring of commercial batches is a mandatory requirement that often generates a large volume of samples and analytical tests, many of which provide redundant data for well-established products. This paper explores a quality risk management (QRM) approach, aligned with ICH Q1A (R2) and Q9 guidelines, aimed at streamlining ongoing stability protocols.
The study defines risk-based criteria to support the reduction of the number of batches included in the ongoing stability program, as well as the implementation of reduced testing frequency for products with well-established historical stability data. This strategic optimization improves operational efficiency within the Quality Control (QC) laboratory by reducing sample throughput and shortening analytical lead times. Furthermore, it significantly contributes to sustainability efforts by minimizing the consumption of organic solvents (e.g.HPLC waste) and reducing overall pharmaceutical and chemical waste. The proposed model provides a robust framework that maintains strict GMP compliance while enhancing cost-effectiveness and reducing environmental impact.