Monitoring and Trending in Pharmaceutical Analysis - Ongoing Procedure Performance Verification (New USP Draft Chapter (1221))

Overview:

In order to ensure quality, safety, and efficacy of pharmaceuticals, an appropriate control of the capability of the manufacturing process (FDA Guidance Process validation, EU GMP Guide Part 1, Annex 15), as well as of the analytical performance (FDA Method Validation-Guidance, EU GMP Guide Part 1, Chapter 6, Quality Control) is important, across the whole lifecycle. A regular evaluation is expected, e.g. as Annual Quality Review (FDA, 21CFR211.180(e)). As part of the analytical procedure lifecycle Stage 3, Ongoing Procedure Performance Verification is proposed as a new USP General Information Chapter (<1221>, Pharm. Forum 51.4 Sept. 2025).

Why you should Attend:

As - unlike for investigation of results outside of specification (OOS) - no detailed regulatory rules are provided in case of results outside of expectation or outside of trends. Therefore, industry has some flexibility to established suitable monitoring and trending programs of own choice. In order to support such programs, participants will learn about the fundamentals of a “normal” distribution of data, to be able to identify results out-of expectation (OOE) and out-of-trend (OOT) and to establish suitable control limits. Tools to identify such suspect results and analyze trends are presented and recommendations provided for the selection, generation, and use of statistical control charts, with special emphasis on pragmatic rules and assessments. A clear distinction between production and analytical root cause is important to draw correct conclusions and to assess the capability of the manufacturing process appropriately.

Areas Covered in the Session:

• Regulatory expectations to the quality of product and analytical results 
• Error types: random and systematic errors
• Distribution of data
• USP draft <1221>, systematic monitoring programme
• Statistical Control Charts and OOE Limits (control chart types and their appropriate selection (individuals and means, CUSUM, EWMA, range, standard deviation control charts)
• Statistical and empirical OOE limits
• Appropriate consideration of variability contributions (manufacturing and analytics, precision levels)

Who Will Benefit:

• Analysts
• Lab Supervisors and Managers in Quality Control
• Quality Assurance
• Production responsible to assess the ongoing performance of analytical procedures and manufacturing processes