Quality control


Quality products is what makes the company competitive and allows it to take leading positions in the market.

Therefore, one of the important elements of the quality system at “Sumyfitofarmacia” Ltd is product quality control.

Physico-chemical, organoleptic, sieving and microbiological quality control is ensured by the availability of appropriate laboratory premises, modern laboratory equipment, documentation and competent personnel who conduct analyzes of medicinal plant raw materials for compliance with the requirements of the Ukrainian Pharmacopoeia and the European Pharmacopoeia. Both laboratories are certified to carry out measurements in the field of legally regulated metrology by type of activity: quality and safety control of food products and medicinal products

Quality control

1

Incoming inspection.

During incoming inspection each batch of raw materials, which comes to the enterprise, is checked.

Upon acceptance, an external inspection of each unit of production is done and all accompanying documents are checked. Attention is given to quality and integrity of packaging (lack of moisture, drips, and other damage which may affect product quality) as well as proper labeling and compliance with applicable regulations. After receipt at the quarantine warehouse samples are taken from the received consignment and sent for analysis to the laboratory, where they are subject to mandatory

  • identification;
  • radiological control;
  • control of the presence of foreign substances;
  • determination of moisture, ash;
  • content of active substances;
  • control of microbiological purity.
  • Only raw materials that have passed all stages of thorough inspection can be transferred for storage in the warehouse for further use in production.
2

Control at intermediate stages (during production).

3

Inspection of finished products

It is carried out from each batch of finished products for compliance with the requirements of the State Pharmacopoeia of Ukraine or other regulatory documents, including customer specifications. Our quality control system also includes regular audits of raw material suppliers. Every year, our company's representatives check the conditions of harvesting, primary drying and storage at our suppliers, in compliance with legal regulations. The quality management system and food safety management system in place at the enterprise makes it possible to perform traceability of all plant raw materials and products at the enterprise, to identify existing risks to prevent the production of low-quality products, as well as to take measures to minimize or eliminate risks.

Laboratory

Organo-leptic

parameters: appearance, color, smell and taste

Physical-chemical

parameters: moisture, ash, foreign materials, flavanoids and active ingredients content

Micro-biological

parameters: purity of raw material

The laboratory is equipped with modern equipment, which allows us to control the quality of plant raw materials on the normative indicators.

Only after receiving the conclusion of the laboratory a decision about the suitability of raw materials for further use is made. In this case, all the requirements set forth in the regulatory documentation are taken into account.

If the quality of plant raw materials does not meet the requirements of normative documentation, they are sent for revision or returned to the supplier. Qualifying raw materials are sent to production for processing or to one of the warehouses for storage.

The company sells only products that have passed laboratory inspection and accepted by the quality control department.

Certification

Sumifitopharmacia Ltd. is certified according to the standards of the Quality Management System (ISO 9001: 2015) and the Food Safety System (ISO 22000: 2018), as well as the System for the production of organic (BIO) products.

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