Process Validation

Verify that processes are reproducible and consistent in delivering quality products according to specifications, and in line with international regulations



Competency Area

Quality Management


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