The Ministry of Health granted S.R.Y. GMP approval for a radiopharmaceutical production line.
As part of our core values, we have enshrined a commitment to an effective, safe and high-quality final product, so 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), which is located in clean rooms, which were established with an investment of 13 million NIS, and the entire process has been adjusted and optimized to meet the highest quality and safety requirements.
GMP – Good Manufacturing Practice or in Hebrew “proper manufacturing conditions”, is part of the quality system, which audits the production sector in the pharmaceutical, medical device, and also food and cosmetics industries. GMP procedures are the guidelines that guide the production stages, which affect the quality of the final product.
Since each step of the process has a potential impact on the quality, efficacy and safety of the final product, Good Manufacturing Practices (GMP) include standards and guidelines that start from the selection and certification of raw material suppliers, through the production and quality control processes, to the storage of the finished product that has successfully passed the release tests and met all specifications. The certification indicates that the company has a high-level quality assurance system, the infrastructure is in order, and all production conditions and processes are adequate, controlled and meet the strict requirements of the Ministry of Health.
The GMP standard is a global standard, and as such is implemented in many places around the world. Many countries have enacted and established their own GMP procedures, but the basic characteristics remain the same and their goal is to ensure the quality of the medical product in order to maintain the health of the end consumer. In the State of Israel, the certificate is issued by the Ministry of Health’s Institute for Quality Control and Standards, which checks the company’s quality system, infrastructure, and production processes for compliance with international GMP procedures (with the reference point being the GMP guide of the PIC/S – Pharmaceutical Co-operation Inspection Scheme) and is recognized by the authorities of the European Union and other countries.
