Certifications & Compliance
Full regulatory compliance for global pharmaceutical markets
Green Medical Packing maintains comprehensive regulatory certifications to ensure our medical-grade PVC sheets meet the highest international standards. Our compliance program covers USP <661>, EP 4.1.1, ISO 15338, GMP, and FDA Registration, providing pharmaceutical companies with the documentation and assurance needed for regulatory submissions across global markets.
ISO 15338
International Organization for Standardization
Valid until: 2027-06
Quality management system certification specific to primary packaging materials for medicinal products, integrating GMP principles with ISO 9001 requirements.
GMP
National Medical Products Administration
Valid until: 2027-12
Good Manufacturing Practice certification ensuring our production processes meet pharmaceutical-grade quality standards.
FDA Registration
U.S. Food and Drug Administration
Valid until: Active — Annual Renewal
FDA Drug Master File registration enabling our materials to be used in pharmaceutical packaging for the U.S. market.
USP <661>
U.S. Pharmacopeial Convention
Valid until: Ongoing — Batch-Level Testing
Full compliance with USP General Chapter <661> requirements for plastic packaging systems and their materials of construction.
EP 4.1.1
European Directorate for the Quality of Medicines
Valid until: Ongoing — Batch-Level Testing
Compliance with European Pharmacopoeia requirements for plastic containers and closures for pharmaceutical use.
Regulatory Standards Explained
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