Good Manufacturing Practice
One of the key drivers behind the establishment of Roslin Cells was the realisation that for stem cell technology to deliver its promise in the therapeutic area it was essential that cell lines were available that were isolated to the highest possible standard that would conform to current and future regulatory requirements.
To ensure we achieve the required standards of quality and to meet regulatory requirements we have an established GMP Quality Management system; the key aspects of which include:
- Fully informed and documented consent procedures for donated tissue
- Procedures to ensure full coded traceability to the tissue donors
- Donor medical history and screening data
- Defined procedures for transfer of material from the clinics including full traceability and temperature controlled shipment
- Defined procedures covering all aspects of stem cell derivation, maintenance and testing
- Traceability of all materials that cells are exposed to, sourced from approved suppliers; Derivation free of exposure to animal derived materials
- cGMP Clean Room Facilities qualified to the appropriate standard
- Fully qualified equipment with continuous monitoring of temperature controlled equipment; Full environmental monitoring programme in place
- Independent Quality Assurance department to assure cGMP compliance and continual improvement
- Controlled document management system for GMP documents including Standard Operating Procedures, Batch Production Records and Validation Documentation
To ensure we maintain a continued state of compliance with existing and evolving regulatory expectations, we are involved in continuous dialogue with the relevant regulatory authorities We also have a number of key members of staff with extensive experience of working within a regulated environment. This experience has been in many areas including bio-manufacturing, Quality Control, Quality Assurance, contract research and clinical trials. This is in addition to the GMP support and experience provided by the Scottish National Blood Transfusion Service (SNBTS) based on its experience in blood, tissues and hematopoietic stem cells.
