Every investor in pharmaceutical manufacturing knows that the Saudi Food and Drug Authority (SFDA) licenses the factory and its products and oversees good manufacturing practice. The environmental side, however, has another authority and another path: the environmental permit for a pharmaceutical factory from the National Center for Environmental Compliance (NCEC), and licensing of hazardous waste carriers by the National Center for Waste Management (MWAN). Confusing these tracks, or postponing the environmental one until the factory is built, delays operation. This article lays out the tracks and the main environmental conditions for pharmaceutical factories.
Four parallel tracks
| Track | Authority | What it covers |
|---|---|---|
| Industrial license | Ministry of Industry and Mineral Resources | Licensing the industrial facility |
| Factory and product license | Saudi Food and Drug Authority | Manufacturing quality and product safety |
| Environmental permit | National Center for Environmental Compliance | The factory's impact on the environment: emissions, discharges, waste and soil |
| Hazardous waste | National Center for Waste Management (MWAN) | Licensing carriers and facilities that receive the waste |
SFDA approval does not replace the environmental permit, and vice versa.
Why pharmaceutical factories are environmentally sensitive
- Pharmaceutical waste: expired raw materials, rejected batches, and expired or returned medicines.
- Solvents and chemicals: in manufacturing, cleaning and laboratories.
- Wastewater: may carry active ingredient residues or solvents from equipment washing.
- Emissions and vapors: from some processes, ventilation systems and boilers.
- Packaging contaminated with pharmaceutical or chemical substances.
The environmental permit step by step
- Before construction: the environmental classification form; NCEC sets the category based on the type and size of manufacturing and the location. The regulation requires environmental impact assessment to be considered in feasibility studies and preliminary designs, so start in parallel with the factory design.
- Construction permit: an environmental management plan for Category 1, or an EIA study for Categories 2 and 3.
- Operating permit: after construction is complete and its conditions met, valid for three to six years.
- Ongoing obligations: self-monitoring reports, records, measurements, and an environmental audit at renewal for Categories 2 and 3 every three years.
Managing pharmaceutical and chemical waste
The Waste Management Law defines hazardous waste as including toxic, flammable or reactive materials and solvents. Pharmaceutical and chemical waste is treated as hazardous: segregated at source, stored temporarily in a secure dedicated area, and handed to an MWAN-licensed carrier for delivery to a licensed treatment facility, with a transport document for every shipment. Anyone depositing waste with an unlicensed party is jointly liable for damages, and disposing of waste in a way that endangers public health or the environment is punishable by imprisonment of up to ten years and a fine of up to SAR 30 million, or either.
Emissions and solvents
If the factory has boilers or stacks, the Air Quality Regulation requires annual measurements of stacks not under continuous monitoring through a licensed provider, initial measurements within 120 days of establishment or 40 days of reaching target production (whichever comes first), maintenance of pollution controls, and records kept for at least five years. Solvent storage is subject to its requirements, including no aluminum or magnesium alloys and vapor recovery for tanks over 5 cubic meters. Boilers and incinerators burning hazardous materials have specific rules, including that only hazardous materials specified in the environmental permit and generated at the facility itself may be burned.
Wastewater
Water from washing equipment and production lines may carry active ingredients and solvents, so it needs suitable treatment before discharge according to permit conditions and the sewer operator's requirements. Dumping untreated wastewater or liquid components into any environmental medium is among the violations heard by the competent court under the Penalties Regulation.
Frequently Asked Questions about Pharmaceutical Factory Permits
Does an SFDA license replace the environmental permit?
No. SFDA oversees manufacturing quality and product safety; the NCEC environmental permit covers the factory's impact on the environment.
How are expired medicines and rejected batches disposed of?
As hazardous waste: segregation and secure storage, then handover to an MWAN-licensed carrier for delivery to a licensed facility, with a document for every shipment.
Does a pharmaceutical factory need an EIA study?
That depends on NCEC's classification based on the type, size and location of manufacturing: Category 1 needs an environmental management plan, Categories 2 and 3 an EIA study.
Does renewal require an environmental audit?
Yes for Category 2 and 3 factories, every three years, under the Environmental Inspection and Audit Regulation.
How Abak Green helps
We manage the environmental track of your pharmaceutical factory in parallel with the SFDA track: classification, construction and operating permits, the hazardous waste management plan, coordination of measurements, records and reports, so operation is not delayed by the environmental file. Contact us about your factory.
