Regulatory Quality Department

For over 60 years, SIMAH has placed quality at the core of its commitment to ensuring total customer satisfaction. Our production facility and processes have been designed in full compliance with Good Manufacturing Practices (GMP) under ISO 22716. These practices guarantee product quality, full traceability at every stage of the process, and consumer safety. They cover key aspects such as staff training on GMP and hygiene, thorough cleaning of facilities and equipment, and strict adherence to procedures throughout the manufacturing and packaging stages. This approach is supported by a dedicated quality team and the entire plant management. SIMAH holds GMP and Ecocert certifications, demonstrating its commitment to safe production and strict regulatory compliance.

       Quality Control Laboratory
To ensure the compliance of our products, SIMAH operates an in-house quality control laboratory, conducting over 20,000 annual analyses on raw materials, bulk formulations, and finished products.
  Types of Controls:
– Physicochemical analyses: Texture, color, odor, viscosity, pH, density, etc.
– Bacteriological testing: Detection and enumeration of bacteria, molds, and yeasts.
– HPLC assays: Measurement of regulated active ingredients, including preservatives and UV filters.
  Environmental Bacteriological Controls:
– Air quality monitoring across different areas of the facility through bacterial sampling.
– Bacteriological control plan for verifying the cleanliness of production equipment.
  Packaging Quality Control:
Quality extends beyond formulation. A dedicated team ensures that packaging meets safety, functionality, and regulatory requirements, guaranteeing optimal product presentation and protection.

       Regulatory Support 
Backed by the extensive experience of the Sothys Group in Europe and internationally, SIMAH offers regulatory support, particularly for the preparation of the Product Information File (PIF) and the CPNP notification in compliance with EU Regulation 1223/2009.