Advanced Level: Trending of Process Data for OPV/CPV - Live Online

Advanced Level: Trending of Process Data for OPV/CPV - Live Online

Course No 18932

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Dr Raphael Bar, BR Consulting


This is an advanced level course divided into two parts on 12 and 13 October 2021.
You will learn:
  • What is Ongoing/Continued Process verification
  • Overview of Control Charts of grouped and individual data
  • Overview of Three-Way charts
  • Overview of Attributes charts
  • Stability and capability of a process
  • Tools for detecting a trend and shift in process average  and/or process variability                                   
  • Reasons for too many statistical false signals in real-life process data
  • Ways to minimize false signals in real-life pharmaceutical and biopharmaceutical processes
  • Components of a CPV/OPV plan
  • Integration  a practical SPC approach into the CPV/OPV plan
  • Examples of control charts of real-life data of pharmaceutical processes, generated with StatGraphics,  will be shown throughout the course


FDA´s Process Validation Guidance and Annex 15 to the EU GMP Guide  require manufacturers to monitor product quality to ensure that a state of control is maintained throughout the validation lifecycle of new products and legacy products during the third process validation stage called Continued Process Verification (CPV) or Ongoing Process Verification (OPV). Indeed, regulatory agencies expect manufacturers to implement also a CPV plan as reflected in FDA warning letters.
The implementation of Stage 3 is translated into establishing an ongoing CPV/OPV program which allows Identification of CPV/OPV signals and defining types of responses to these signals. However, real-life data of pharmaceutical and biopharmaceutical processes rarely meet the fundamental  assumtioms of the conventional  SPC (Statistical Process Control), This in turn  leads often to false signal alarms, which entail futile investigations of innocuous events. Thus, a practical approach is called for and it consists of collecting, charting and evaluating product and process data under relaxed and adjusted SPC rules, allowing  a streamlined implementation of the CPV/OPV program.

Target Group

This is an advanced level course, therefore a knowledge on control charts is an advantage. Experienced employees from companies, who are involved in pharmaceutical process validation activities (developers, QM, manufacturing, heads of validation departments, etc.) especially regarding stage 3 ongoing/continued process verification, are addressed. Of course consultants in this field, who want to get information from the view of the medicinal product manufacturers, are addressed too.

Technical Requirements

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  • What is Ongoing/Continued Process verification
  • Regulations
  • What data to trend
  • Process inputs and outputs: CPP and CQA
  • NOR, PAR and Design Space
  • Run Chart versus Control Chart
  • Common cause variation versus special variation
  • “State of Control”
Overview of Control Charts of variables
  • Overview of Control Charts of grouped data
  • Overview of Control Charts of individual data
  • Overview of Three-Way charts
  • Capability indices (Cp, Cpk, Pp and Pk)
  • Stability and capability of a process
  • Examples: control charts of Assay, impurity, of UOC, dissolution
Overview of Control Charts of attributes
  • Their use in the pharmaceutical industry
  • Np and p control charts
  • c and u control charts
  • xamples: control Np charts of inspected packages (defective), c charts of non-conformities (defects)
  • in labels of a drug product; c chart of environmental microbial counts
Evaluation of a control chart
  • Nelson rules for detecting trends and shifts
  • “State of Control” versus “State of Statistical Control”
  • Phase I and Phase II in control charting
  • “Statistical Limits” versus “Regulatory Limits”
  • Are all statistical assumptions valid in real-world pharmaceutical process data?
Adjusting SPC rules to pharmaceutical process data
  • Which statistical rules can be relaxed
  • Setting practical limits
  • Examples of process behaviour charts
  • Components of a CPV/OPV Plan
  • Identification of CPV Signals
  • Types of responses to signals

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