QUALITY
Every formula passes the same four-gate review before it ships: GMP manufacturing controls, ISO 22716 cosmetic-GMP audit, market-specific regulatory registration, and a country-specific dossier for every market we serve. When local regulation changes, the dossier follows on the same week — pharmacists in the markets we serve receive the update through the same channel that delivered the original registration. If a recall is needed, the affected batch is identified in hours.
Quality at BIOSAR is procedural, not aspirational. This page walks through the four gates in order: what is checked, who signs it off, and the record it leaves. A pharmacist or regulator can trace any batch from raw material to shelf.
Independent certifications
Our quality framework
Manufacturing operates under documented GMP procedures across every production line. Independent third-party auditors verify the procedures annually. The audit pack covers raw-material handling, equipment calibration, sanitation, batch records, and personnel training.
ISO 22716 is the international cosmetics-GMP standard. BIOSAR Laboratories is certified to ISO 22716 with continuous audit cycles, covering production, control, storage, and shipment of finished cosmetic products.
Every BIOSAR product sold in Saudi Arabia carries a unique SFDA registration code. The registration covers full INCI, claim language, and label artwork. Updates are filed before any change reaches the Saudi pharmacy shelf.
Each market we serve has its own regulatory dossier. Dossier maintenance is part of the partnership: when local regulation changes, the dossier follows on the same week.
Batch-level documentation
Production runs are documented at the batch level. Records cover raw-material sourcing, weighing, blending parameters, fill volumes, microbiological challenge results, and stability outcomes. Independent third-party auditors review the documentation annually and at any unscheduled inspection.
Living dossiers
Regulatory dossiers are maintained continuously. When a market revises its cosmetics regulation, our regulatory affairs team files an update before the change takes effect. Pharmacists in the markets we serve receive notification of any reformulation, label change, or batch recall through the same channel that delivered the registration.
Regulatory questions?
Pharmacists, distributors, regulators — write to us, and we will respond with the records and documentation.
Open the contact form