Tag: validation in pharma company

Legacy Equipment Documentation Checklist for Audits

Legacy Equipment Documentation Checklist for Audits Legacy Equipment Documentation Checklist for Audits In the pharmaceutical industry, validation is a critical aspect of ensuring that processes, systems, and equipment operate according to intended specifications and regulatory requirements. This comprehensive guide will…

Statistical Tools for CPV: SPC, Control Charts, and CpK

Statistical Tools for CPV: SPC, Control Charts, and CpK Statistical Tools for CPV: SPC, Control Charts, and CpK Continued Process Verification (CPV) is a critical phase in the pharmaceutical validation lifecycle. As regulatory frameworks evolve, particularly with guidance from the…

QA Oversight During PPQ Execution: What to Review

QA Oversight During PPQ Execution: What to Review QA Oversight During PPQ Execution: What to Review Step 1: Understanding the Purpose of Process Performance Qualification (PPQ) The Process Performance Qualification (PPQ) phase is critical within the lifecycle of validation in…

Incorporating PAT Tools in Stage 2 Process Qualification

Incorporating PAT Tools in Stage 2 Process Qualification Incorporating PAT Tools in Stage 2 Process Qualification Process validation is a critical component of pharmaceutical manufacturing that ensures products are produced consistently and meet required quality standards. Within the validation lifecycle,…