The FDA in 2011 provided a guidance titled “Process Validation: General Principles and Practices” for Process Validation in the pharmaceutical industry, during which it established a framework for the same. This framework consists of a three-stage process:
1) Process Design
2) Process Qualification, and
3) Continued Process Verification.
So, what is Process Validation? It is described in Guidance for Industry Process Validation: General Principle and Practices as “…the collection and evaluation of data, from the process design stage through commercial production…” into which the three stages described above are delineated in this Guidance:
Stage 1: Process Design: This is the stage in which commercial manufacturing process is defined, based on knowledge gained through development and scale-up activities
Stage 2: Process Qualification: The stage in which the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
Stage 3: Continued Process Verification: Gives the ongoing assurance during routine production that the process remains in a state of control.
While this much is for theory, how do organizations understand the ways to implement these practically? These will be explained in detail at a two-day seminar that is being organized on November 5 and 6 by GlobalCompliancePanel, a leading provider of professional training for the areas of regulatory compliance.
Being organized in Philadelphia, PA, this in person, live seminar will feature the Co-founder and Principal, Adsurgo, Heath Rushing, as the Director. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. Please register for this valuable learning session by visiting https://www.globalcompliancepanel.com/seminar/applied-statistics-for-FDA-process-validation-901969SEMINAR
The aim of this course is to help its participants understand how to establish a systematic approach for implementing statistical methodologies into a Process Validation program that is consistent with the FDA guidance. The Director will begin with a primer on statistics, at which he will focus on the methods that will be applied in each remaining chapter.
He will then move on to giving an understanding of how to apply statistics for setting specifications and assessing measurement systems (assays), which are considered the two foundational requirements for Process Validation.
In the third and final step, the Director will show how to apply statistics through the three stages of process validation defined by requirements in the Process Validation regulatory guidance documents.
He will take up methods recommended by regulatory guidance documents through all these three stages and provide references to the specific citations in the guidance documents.
Heath will explain how to apply statistics for a range of functions. These include how to:
- Set specifications
- Assess measurement systems (assays)
- Use Design of Experiments (DOE)
- Develop a control plan as part of a risk management strategy
- Ensure process control/capability.
Although established for the pharmaceutical industry, it is a useful framework for other industries. Analyses in this course use the point-and-click interface of JMP software by SAS.
At this seminar, the Director will cover the following areas:
- Apply statistics to set specifications and validate measurement systems (assays)
- Develop appropriate sample plans based on confidence and power
- Implement suitable statistical methods into a process validation program for each of the three stages
- Stage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using Design of Experiments (DoE)
- Stage 2, Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQ
- Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.
Pharmaceutical and biopharmaceutical professionals who are involved with product and/or process design, validation, or manufacturing/control, such as Process Scientist/Engineer, Design Engineer, Product Development Engineer, Regulatory/Compliance Professional, Design Controls Engineer, Six Sigma Green Belt, Six Sigma Black Belt, and Continuous Improvement Manager will benefit from this seminar.