Risk-Based Intermediate Precision Studies for Analytical Procedure Validation

News
Article
Pharmaceutical TechnologyPharmaceutical Technology-09-15-2019
Volume 2019 eBook
Issue 2
Pages: 12–22

Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.

Validation of analytical procedures requires study of intermediate precision for within-laboratories variations; however, there is no global guidance on how to develop such designs. By applying science- and risk-based principles-aligned with quality by design (QbD)-to analytical procedures, studies can be designed to ensure the factors selected present the highest risk of impacting the performance of the analytical procedure. In addition, the number of independent analytical runs to include in these designs should be linked to the overall risk/complexity associated with the analytical procedure.

Useful pre-QbD guidance (provided by the Japanese National Institute of Health Sciences) proposed the use of a generic design which utilizes six independent analytical runs. Examples are provided which instead link the design structure and the number of independent analytical runs to the risk.

Read this article in Pharmaceutical Technology’s September 2019 Regulatory Sourcebook.

 

Article Details

Pharmaceutical Technology
eBook: Regulatory Sourcebook, September 2019
September 2019
Pages: 12–22

Citation

When referring to this article, please cite it as P.J. Borman, et al., “Risk-Based Intermediate Precision Studies for Analytical Procedure Validation," Pharmaceutical Technology Regulatory Sourcebook eBook (September 2019).

Recent Videos
Drug Digest: Strategic Partnerships
Tore Bergsteiner from MAIN5 details his predictions for how the mega trends will shape the bio/pharma industry in 2025 and beyond.
Roger Viney from ICE Pharma discusses the quality and compliance issues surrounding the use of animal-derived ingredients in the bio/pharma industry.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.