The Ministry of Health has granted S.R.Y. a GMP certification for a radiopharmaceutical production line.
As part of our core values, we have committed ourselves to delivering a final product that is effective, safe to use, and of the highest quality. This means that the end user, whether a patient, a treating physician, or a medical center, can rely on our product with a high level of confidence.
Production is carried out in an isolator (Grade A), located within clean rooms built with an investment of 13 million NIS. The entire process has been adapted and optimized to meet the highest quality and safety requirements.
GMP – Good Manufacturing Practice is part of the quality system that oversees manufacturing in the pharmaceutical, medical device, food, and cosmetics industries. GMP guidelines define the principles of manufacturing, quality control, and quality assurance, all of which directly impact the quality of the final product.
Since every stage of the process can potentially influence the quality, efficacy, and safety of the final product, GMP standards and guidelines cover all stages: from selection and qualification of raw material suppliers, through manufacturing and quality control processes, to storage and distribution of the final product, which successfully met its release criteria.
The certification confirms that the company has a high-level quality assurance system, proper infrastructure, and that all manufacturing conditions and related processes are appropriate, controlled, and meet the regulator’s strictest requirements.
GMP is a global standard implemented in many countries worldwide. While each country may establish its own GMP procedures, the basic principles remain the same, aiming to ensure the quality of medical products and to protect consumers’ health and safety.
In Israel, the certification is issued by the Institute of Pharmaceutical Standards and Quality Control of the Ministry of Health, which inspects the company’s quality system, infrastructure and manufacturing processes for compliance with international GMP guidelines (using the GMP guide of the PIC/S – Pharmaceutical Co-operation Inspection Scheme as a reference). This certification is recognized by the European Union authorities and by additional countries.
