GMP Compliance Checklist for New Pharma Facilities
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Posted by Adroitix Engineering Filed in Business #HVAC design for pharma manufacturing #cGMP facility design consultancy 11 views
Introduction
Good Manufacturing Practices (GMP) lie at the heart of trust in pharmaceutical products. When opening a new facility, compliance with GMP is not optional - regulators worldwide demand rigorous adherence. This checklist helps you ensure your new facility meets both Indian and global (FDA, EMA, PIC/S) expectations.
Adroitix Engineering, expert EU GMP facility design consultants, ensures full compliance with global GMP standards for new pharma facilities. From layout planning to cleanroom design and validation, Adroitix integrates regulatory guidelines into every stage of development, helping clients build facilities that meet stringent EU quality, safety, and documentation requirements for seamless global regulatory approval.
GMP Compliance Checklist
Below is a structured checklist, grouped by domain, that you should verify before commissioning or audit:
Domain
Key Items
Notes / Acceptance Criteria
Organization & Personnel
GMP training program; organization chart with responsibilities; hygiene & gowning practices
Documented training records, access controls
Building & Facilities
Cleanroom classification & pressure cascade; material & personnel flow; surface finishes; gowning rooms; maintenance access
Floor, wall, ceiling materials compatible with cleaning
Utilities & Services
HVAC design for pharma manufacturing, compressed air, steam, chilled water, vacuum, nitrogen, electrical systems
Redundancy, alarms, monitoring
Water Systems
PW system, WFI system, piping design, sampling points, sanitization
Temperature, conductivity, TOC, microbial limits
Equipment
GMP grade equipment, material of construction, cleanability, calibration, spare parts
FAT/SAT, preventive maintenance
Qualification & Validation
DQ, IQ, OQ, PQ; cleaning validation, process validation, computer system validation
Protocols + reports, traceability
Quality Management System (QMS)
SOPs, change control, deviation/CAPA, audit program, management review
Documented control, version management
Documentation & Records
Batch records, calibration, maintenance logs, cleaning logs, deviation reports
Document control, retention policy
Raw Materials & Incoming
Vendor qualification, certificate of analysis (COA), quarantine, sampling, testing
Supplier audit records
Production & Process Controls
In-process controls (IPCs), monitoring, controls on critical process parameters
Statistical justification, sampling
Microbiology & Environmental Monitoring
Viable & non-viable particle monitoring, microbial limits, trend review
Defined frequency, control limits
Laboratory Controls
Validated analytical methods, calibration of instruments, reference standards
Stability studies, control charts
Computer Systems / Automation
Software validation, audit trails, data integrity (21 CFR Part 11 or equivalent)
Change control in software, user access
Change Control & Deviation Handling
Formal process for changes, risk assessment, impact analysis
CAPA tracking, review board
Complaint & Recall Handling
Procedures, investigation, trending, recall readiness
Simulation of mock recall
Security & Access Control
Access restrictions (clean zone doors, electronic locks), CCTV, personnel ID
Logs, periodic reviews
Maintenance & Housekeeping
Preventive maintenance schedule, cleaning SOPs, pest control
Logs, inspection checklists
Environmental & Waste
ETP, effluent disposal, hazardous waste management, solvent recovery
Regulatory compliance, emission norms
Calibration & Metrology
Calibration intervals, traceability to standards, master equipment list
Calibration certificates & logs
Personnel Safety & Training
PPE, safety SOPs, emergency response, fire drills
Safety audits, mock drills
Additional Considerations
- Risk-based approach: Not all systems require the same level of validation-prioritize critical systems.
- Data integrity: Comply with ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available).
- Alignment with regulatory updates: E.g. India’s revised Schedule M updates.
- Mock audits & readiness checks: Conduct internal audits as if by regulator.
- Continuous re-assessment: After deviations or process changes, revisit impacted systems.
Conclusion
This GMP compliance checklist acts as your guide to systematically confirming every critical component is in place before operations. A rigorous review against this list helps diminish audit observations, ensure product quality, and safeguard regulatory approval.