Lifecycle Management of Analytical Procedures

Lifecycle Management of Analytical Procedures: Achieving Quality and Conformity

The Analytical Procedure Life Cycle (APLC) is an essential framework employed in the pharmaceutical and biotech industries not only in the development and validation of the methods. Continuity is achieved to guarantee the consistency in quality, accuracy and reliability of the outcomes. According to the survey conducted in BioPhorum across 91 participants in the year 2022, it was found that more than forty percent of companies don’t know how to address method robustness after validation, hence addressing the importance of method lifecycle management.

In this article, we’ll explore three key elements of APLC management: continuous monitoring and control post-validation, change management and revalidation, and risk management from the life cycle. The above strategies can help a laboratory to achieve a level of consistency to avoid complacency, be in compliance with the FDA and EMA and improve operations.

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Overseas Monitoring and Control After the Validation

Thus, it is critically important to check the selected analytical methods constantly once they are proven to be effective for the analysis of biochemical objects. Pharmaceutical Technology pointed out that 30% of method deviations are detected at System Suitability Testing (SST) and through trend analysis. Strengthening monitoring over enables the attainment of periodic correct method compliance while eradicating chances to errors.

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Key Continuous Monitoring Components:

System Suitability Testing (SST): Routine SSTl; checks not......