India Pharmaceutical GMP Audit Checklist
Comprehensive India pharmaceutical GMP audit checklist.
- Industry: Manufacturing
- Frequency: Monthly/Quarterly
- Estimated Time: 90-120 minutes
- Role: QA Manager/GMP Auditor
- Total Items: 22
- Compliance: Schedule M, WHO GMP, PIC/S Guidelines
Premises
Facility design
- Layout prevents cross-contamination?
- HVAC system qualified?
Documentation
Records
- BMRs followed?
- Deviation management in place?
Quality Control
Testing
- Lab equipment calibrated?
- Stability program in place?
Machine Guarding & Safety
OSHA 1910 Subpart O machine safety
- Machine guards in place and functional?
- Emergency stop buttons tested?
- Safety light curtains operational?
- Safety interlocks functional?
Chemical & Hazardous Materials
HazCom and chemical safety per OSHA 1910.1200
- SDS sheets available for all chemicals?
- All chemical containers properly labeled?
- Secondary containment in place?
Ergonomics & Workplace Design
Ergonomic risk assessment
- Workstation heights appropriate?
- Lifting aids available where needed?
- Anti-fatigue mats at standing stations?
Quality Control Checks
Product quality verification
- Measurement tools calibrated?
- Defect rate within acceptable limits?
- First article inspection completed?
Environmental Controls
Ventilation and environmental monitoring
- Ventilation systems operating properly?
- Noise levels within permissible limits?
- Adequate lighting at all workstations?
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Why Use This India Pharmaceutical GMP Audit Checklist?
This india pharmaceutical gmp audit checklist helps manufacturing teams maintain compliance and operational excellence. Designed for qa manager/gmp auditor professionals, this checklist covers 22 critical inspection points across 8 sections. Recommended frequency: monthly/quarterly.
Ensures compliance with Schedule M, WHO GMP, PIC/S Guidelines. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the India Pharmaceutical GMP Audit Checklist cover?
This checklist covers 22 inspection items across 8 sections: Premises, Documentation, Quality Control, Machine Guarding & Safety, Chemical & Hazardous Materials, Ergonomics & Workplace Design, Quality Control Checks, Environmental Controls. It is designed for manufacturing operations and compliance.
How often should this checklist be completed?
This checklist should be completed monthly/quarterly. Each completion takes approximately 90-120 minutes.
Who should use this India Pharmaceutical GMP Audit Checklist?
This checklist is designed for QA Manager/GMP Auditor professionals in the manufacturing 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.