The trust that the patient gives us is an obligation for the entire Luna Laboratory team.
When human life and health count, quality and safety issues are of the utmost importance. That is why in the Luna Laboratory we apply the highest existing standards to ensure safe and effective cell therapy for patients.
The drug developed by us and used in therapy, classified as an advanced therapy medicinal
product (ATMP), is subjected to special legal provisions ensuring the protection of patient's health. Its production requires the consent of the Chief Pharmaceutical Inspector, which is related to compliance by Luna Laboratory with strict quality and safety requirements for drug development. In addition, the drug received a scientific recommendation from the European Medicines Agency.
The Quality Management System implemented in our company is based on the following
legal acts:
1. Regulation of the Minister of Health of 9 November, 2015 on the requirements of Good
Manufacturing Practice (as amended)
2. Regulation of the Minister of Health of 9 May 2012 regarding Good Clinical Practice
3. Act of 6 September, 2001. Pharmaceutical Law (as amended)
4. Act of 1 July 2005 concerning taking, storage and transplantation of cells, tissues and
organs (as amended)
5. Act of 5 December 1996 on the professions of a doctor and a dentist (as amended)
6. Regulation of the Minister of Health of 23 April 2007 on the qualifications required for
persons employed in tissue and cell banks
7. Regulation of the Minister of Health of November 20, 2006 on professional and sanitary
requirements for tissue and cell banks
8. Regulation of the Minister of Health of 9 October 2008 on the requirements to be met by
a quality assurance system in tissue and cell banks (as amended)
9. Regulation of the Minister of Health of 29 September 2016 on specific conditions for the
collection, storage and transplantation of cells, tissues and organs
10. Regulation of the Minister of Health of 6 June 2017 on unique labeling, the way of
marking and monitoring of cells, tissues and organs
11. Regulation of the Minister of Health of 30 March 2010 concerning training of people
whose activities have direct impact on quality of cells, tissues or organs, as well as safety of donors and recipients
12. Guides and guidelines of the European Medicines Agency (EMA)
In addition, we declare:
1. management's responsibility for meeting the requirements of Good Manufacturing
Practice (GMP) and Good Clinical Practice (GCP)
2. subordination of our management system to quality aspects,
3. involvement of the company's crew members in quality matters,
4. continuous improvement of the Quality Assurance System.
