Inspection of the handling of tissues and cells for the manufacture of medicines
- Published: December 10, 2020
- Last updated: December 10, 2020
To operate as a tissue establishment, an authorisation from the Swedish MPA is required. Before authorisation can be granted, an inspection shall be carried out. The inspection is carried out in order to obtain information on how the activity meets the requirements of good quality and safety and how well they comply with the regulatory framework in this area.
Tissue establishments are inspected every other year.
When an inspector inspects the tissue establishment, the following is reviewed, inter alia:
- organisation and personnel documents;
- the quality system;
- how documents are archived;
- how traceability is ensured from the donor to the manufacturer and the recipient of the medicinal product;
- computerised systems:
- how non-conformities are dealt with;
- how self-inspections are carried out;
- premises, equipment and consumables that are used.
Regulations
In Swedish
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Swedish Medical Products Agency (Läkemedelsverket)
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