Process Validation
Verify that processes are reproducible and consistent in delivering quality products according to specifications, and in line with international regulations
Type
Domain
Competency Area
Quality Management
Levels
Evaluate data to establish whether processes are reproducible and capable of consistently delivering quality products
Evaluate data on the performance of manufacturing processes and production outputs
Detect and evaluate deviations of process variables from process plants’ steady state condition to determine root causes
Identify and record deviations in production attributes and parameters
Identify possible sources of variability in product and process quality
Perform impact analysis for identified root causes
Evaluate the re-usability of materials to establish usable lifetimes of materials
Document investigations and data analyses performed as per organisational procedures
Develop process validation procedures and evaluate validation results
Plan process validation tests, procedures and schedules in accordance with regulations and Current Good Manufacturing Practices (CGMPs)
Establish procedures for production attributes and parameters deviation detection, control, and mitigation
Evaluate the analytical methods used in process validation analysis
Describe the statistical methods to be used process validation to analyse data collected
Facilitate the integration of PAT into process validation procedures
Assess the impact of changes in processes on production efficiency and validation requirements
Evaluate key results and findings from process validation tests and analyses
Confirm the uniformity of product and process quality
Draft Process Performance Qualification (PPQ) reports
Formulate process validation strategies across the manufacturing process chain
Liaise with relevant departments to develop organisation-wide process validation plans, which incorporate Process Performance Qualification (PPQ) protocols
Determine optimal manufacturing conditions for required operating parameters, processing limits and raw material inputs
Determine data collection and evaluation requirements
Determine acceptance criteria for each process step
Develop sampling plans, assuring statistical confidence of quality within and between batches
Develop strategies for addressing deviations from expected conditions and managing non- conforming data
Direct the implementation of process controls during the process design and qualification phases
Communicate key insights from process validation analyses to relevant stakeholders