Theracell has established an Advanced Quality System (AQS), which comprises the following accreditations and certifications:
Theracell’s operations are certified by an ISO 9001:2008 by Lloyd’s Register. It is of the few biotechnology companies that has obtained an ISO in the field of “Cell and Tissue Processing for Regenerative Medicine Applications”. This way Theracell has set the standards in regenerative biotechnology and regenerative medicine at a worldwide level. (Click here for the Certificate).
Theracell was successfully audited and has obtained a WHO-GMP certification in the field of “Cell and Tissue Processing for Regenerative Medicine Applications”. It is the only biotechnology company with a GMP certification in the processing and production of advanced cell therapy products, ensuring this way the delivery of therapies of the highest quality standards. (Click here for the Certificate).
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to the highest quality standards. The adherence to GMP at all levels of the production process, from the donor to the recipient, is a prerequisite for consistent quality in the preparation of products intended for human use, such as pharmaceuticals and biological preparations (cells, blood derivatives, etc.).
GMP prevents errors that cannot be eliminated through quality control of the finished product. Without GMP it is impossible to be sure that every unit of a biological or pharmaceutical preparation is of the same quality as the units of medicine tested in the laboratory. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.
GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made. WHO has established detailed guidelines for good manufacturing practice and many countries have formulated their own requirements for GMP based on these guidelines.
Theracell’s clean rooms have been certified to operate in accordance with the ISO 14644-1 standards and the EU GMP Medicinal Products Annex 1. They are therefore specifically designed for the advanced processing of cells and tissues for regenerative medicine applications (Click here for the certificate).
According to the certification, the classification of our state-of-the-art clean rooms is as follows:
- Classification according to ISO 14644-1: Class 5
- Classification according to EU GMP Annex 1: Grade B (at rest)
Our clean rooms are constantly monitored to operate according to the above standards and are certified on a yearly basis.