GMP Audit Checklist for ODF Production Lines

For ODF (Oral Dissolvable Film) manufacturers aiming to enter both dietary supplement and pharmaceutical markets, GMP audits are a critical milestone. Selecting pharmaceutical-grade GMP-compliant equipment from the very beginning not only streamlines the audit process but also reduces the risk of costly production adjustments later.

1. Hardware Requirements

• Material Contact Parts: All contact surfaces should be made of pharmaceutical-grade stainless steel or approved food-grade alternatives, ensuring safety and corrosion resistance.
• Cleanability: Structural design must avoid dead corners and allow quick disassembly for thorough cleaning.
• Cleanroom Environment: Drying and packaging areas should feature environmental monitoring and real-time data logging.

For example, the MJ150-L ODF Film Coating Machine is designed with GMP-grade material contact parts and easy-to-clean modular components, making it ideal for small-scale GMP-compliant production.

2. Data & Record Requirements

• Parameter Traceability: Automated recording of coating speed, temperature, humidity, and film thickness.
• Complete Batch Records: Include raw material batch numbers, production times, operator signatures, and change control logs.
• Deviation & Change Management: Maintain SOPs and full approval records to ensure audit readiness.

The MJ150 ODF Film Making Machine supports full-process data recording and export, ensuring seamless compliance for both supplement and pharmaceutical-grade production.

3. Training & Audit Preparedness

• Regular GMP training for production and quality control staff.
• Mock Q&A sessions and on-site rehearsals before formal audits.

When paired with the MJF180 ODF Cutting & Packaging Machine, manufacturers can ensure not only process compliance but also maintain sterility and packaging integrity required by GMP standards.

4. HUANGHAI Advantages

• Full ODF production line solutions—from coating to packaging—compliant with both dietary supplement and pharmaceutical-grade GMP.
• Provision of complete IQ/OQ/PQ validation documents for registration and international audits.
• Integrated real-time data recording, export, and audit traceability functions across the entire line.

Conclusion

GMP audits are not merely regulatory formalities—they are a comprehensive assessment of a manufacturer’s operational capabilities. By integrating compliance into both equipment design and production processes from day one, ODF manufacturers can ensure long-term stability and competitiveness in global markets. HUANGHAI’s pharmaceutical-grade GMP-compliant ODF solutions are trusted worldwide to meet these high standards.