Sterile Manufacturing Inspection - FREE PDF
Inspect sterile manufacturing operations for contamination control.
- Industry: Pharmaceutical
- Frequency: Per batch / Daily
- Estimated Time: 2-4 hours
- Role: QA / Sterile Operations
- Total Items: 30
- Compliance: FDA Guidance Sterile, EU Annex 1, 21 CFR 211
Pre-Inspection Setup
Verify conditions before proceeding.
- Proper authorization obtained?
- Required documentation available?
- Safety precautions in place?
Inspection Items
Detailed inspection per FDA Guidance Sterile.
- Overall condition acceptable?
- Regulatory compliance verified?
- Safety features functional?
- Documentation current?
Deficiencies & Corrective Actions
Document findings and required actions.
- Inspection Result
- Deficiencies Description
- Corrective Actions Required
- Follow-up Date
- Inspector Signature
Initial Setup & Documentation
Complete initial documentation and preparation
- Inspector / Assessor Name
- Date
- Location / Area
- Inspection Type
- Previous findings reviewed?
Safety & Compliance Verification
Verify all safety requirements are met
- All safety protocols being followed?
- Emergency exits clear and accessible?
- First aid supplies available and stocked?
- All hazards identified and controlled?
- Required PPE being worn correctly?
Operational Standards Check
Verify operational standards and procedures are maintained
- Standard operating procedures being followed?
- All equipment in proper working condition?
- Maintenance schedule current?
- All staff training current and documented?
Quality Assessment
Evaluate quality standards and performance metrics
- Quality standards met for all items checked?
- Any deficiencies or non-conformances identified?
- Root cause analysis completed for issues?
- Continuous improvement opportunities identified?
Related Pharmaceutical Checklists
- Batch Record Review Checklist - FREE PDF
- Equipment Validation Protocol - FREE PDF
- Deviation Investigation Checklist - FREE PDF
- Pharmaceutical Gmp Batch Record Review Checklist
Why Use This Sterile Manufacturing Inspection?
This sterile manufacturing inspection helps pharmaceutical teams maintain compliance and operational excellence. Designed for qa / sterile operations professionals, this checklist covers 30 critical inspection points across 7 sections. Recommended frequency: per batch / daily.
Ensures compliance with FDA Guidance Sterile, EU Annex 1, 21 CFR 211. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Sterile Manufacturing Inspection cover?
This checklist covers 30 inspection items across 7 sections: Pre-Inspection Setup, Inspection Items, Deficiencies & Corrective Actions, Initial Setup & Documentation, Safety & Compliance Verification, Operational Standards Check, Quality Assessment. It is designed for pharmaceutical operations and compliance.
How often should this checklist be completed?
This checklist should be completed per batch / daily. Each completion takes approximately 2-4 hours.
Who should use this Sterile Manufacturing Inspection?
This checklist is designed for QA / Sterile Operations professionals in the pharmaceutical industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.