Analytical Method Development and Validation

A key component of pharmaceutical and biotechnology product development is to perform process validation and qualification studies. The basic concepts, requirements and statistical methods for process validation are presented.

Course Objectives

1. Design, analyze and report validation studies
2. Select appropriate analytical tools for process validation
3. Define process controls and reviews for continued process verification
4. Determine sample size for validation studies
5. Determine sources of process and material variation
6. Establish process capability and design margin
7. Report on process validation and qualification performance
8. Apply JMP to validation data analysis and reporting

Attendees

This course is required for all employees who actively work on process sciences, process development and process validation.

Prerequisites

There are no prerequisites for this course.

Section I: Process Qualification and Validation Introduction

Process Validation and Drug Quality
General Approach to Process Validation
Statutory and Regulatory Requirements for Process Validation
Process Validation Recommendations

Section 2: Stage 1: Process Design

Building and Capturing Process Knowledge and Understanding
Establishing a Strategy for Process Control

Section 3: Stage 2: Process Qualification

Design of a Facility and Qualification of Utilities and Equipment
Process Performance Qualification
PAT during Qualification
PPQ Protocol
PPQ Protocol Execution and Report

Section 4: Stage 3: Continued Process Verification

Establishing a Monitoring Program
Data Analysis Trending and ongoing Capability Monitoring
Deviations/Investigations and CAPA
Change Control
Complaints
CPV Data Review and Reporting

Section 5: Analytical Tools for Process Validation

DOE design space
DOE, CPP and PAR analysis
POV and Sample Size during PV
Process Capability and Design Margin
Control Charts during Validation
ANOVA and ANOM
Equivalence Testing