Process Performance Qualification (PPQ) Stage 2 Readiness Checklist

Stage 1 Prerequisites

Confirm process design outputs support qualification.

• Is the commercial process defined with critical process parameters (CPPs) and critical quality attributes (CQAs) derived from Stage 1 development? *
• Is a control strategy documented that links CPPs and material attributes to CQAs? *
• Are all facilities, utilities, and equipment supporting the process qualified? *
• Have analytical methods used for PPQ testing been validated? *

PPQ Protocol Content

• Is an approved PPQ protocol in place prior to executing any qualification batch? *
• Does the protocol define the number of PPQ batches and the scientific rationale for that number? *
• Does the protocol specify manufacturing conditions, including operating parameters and ranges? *
• Are the acceptance criteria pre-defined and measurable for each stage of the process? *
• Record the number of PPQ batches planned.

Sampling and Testing Plan

• Does the sampling plan include increased sampling relative to routine production to assess intra- and inter-batch variation? *
• Are sampling locations, frequencies, and quantities justified statistically? *
• Is homogeneity/uniformity assessed at defined points in the process? *
• Are personnel executing sampling trained and qualified on the protocol? *

Execution and Data Capture

• Were PPQ batches manufactured under routine conditions by trained operators using commercial procedures? *
• Are all CPPs recorded contemporaneously and within the defined ranges? *
• Are deviations during PPQ documented, investigated, and impact-assessed before proceeding? *
• Describe any deviation or excursion encountered during the PPQ campaign.

Data Analysis and Acceptance

• Do all PPQ batch results meet the pre-defined acceptance criteria? *
• Is inter-batch and intra-batch variability evaluated statistically? *
• Is a PPQ summary report approved by the quality unit before commercial distribution of PPQ batches? *
• Is the transition to Stage 3 Continued Process Verification defined? *