1. Premises and Equipment

• Use dedicated and clean facilities for production, storage, and filling of gases.

• Ensure gas cylinders, pipelines, valves, regulators, and manifolds are properly maintained and validated.

• Prevent cross-contamination between medical and industrial gases.

2. Raw Material Control

• Source gases from qualified and approved suppliers.

• Perform identity and purity testing for all incoming bulk gases.

• Maintain certificates of analysis (CoA) for raw gases.

3. Production and Filling

• Use validated processes for gas compression, purification, mixing, and liquefaction.

• Ensure cylinders are visually inspected, hydro-tested, and cleaned before filling.

• Apply correct labeling during and after filling operations.

4. Quality Assurance and Control

• Test gases for identity, purity, moisture, hydrocarbons, carbon monoxide, and microbial contamination (where applicable).

• Monitor pressure, volume, and correct labeling to ensure compliance.

• Maintain batch manufacturing records with traceability.

5. Cylinder Management

• Separate empty, full, and quarantined cylinders.

• Use color coding and proper labeling as per pharmacopeial and regulatory guidelines.

• Implement a recall system for defective cylinders.

6. Documentation

• Maintain SOPs for production, filling, cleaning, testing, labeling, and distribution.

• Record all activities (batch records, test reports, cleaning logs).

• Ensure data integrity and audit trails.

7. Personnel and Training

• Train staff in GMP, gas handling, and safety procedures.

• Use protective equipment while handling gases under pressure.

• Restrict unauthorized access to production and filling areas.

8. Distribution and Storage

• Store medical gases in controlled, ventilated areas.

• Maintain records of distribution for traceability.

• Ensure transport in dedicated, safe, and compliant vehicles.

9. Regulatory Compliance

• Follow pharmacopeial standards (IP, BP, USP, EP).

• Comply with ISO standards for medical gases and cylinders.

• Implement pharmacovigilance for reporting adverse events related to medical gases.