Qualification/Validation of transport of Products from place of dispensing to patients of CG Store and distribute all Products under appropriate conditions in compliance with requirements and any licence requirements Maintain the integrity of the cold/ambient chain. Distribute to patients in a timely way as described in the contract specification and service level agreement. Maintain an audit trail to the patient. This should include both product and delivery details e.g. batch numbers and delivery times. CG CA Remarks 7. Documentation Ensure that prescriptions as well as records of procurement, dispensing and distribution are clear, readily available and retained for the period required by current legislation. Records shall ensure the traceability of the origin and destination of Products. Ensure written procedures are available to describe all operations that may affect the quality of the Products. E.g. dispensing and distribution Archiving of dispensing and distribution documentation Maintain a record of batch numbers of products procured, supplied or returned in the event of a recall (see section 10). Batch numbers for supply and return should be recorded to patient level. CG CA Remarks 8. Other Quality Control and Quality Assurance Make available evidence of closure of, and assigned risk rating for, regulatory body inspection reports as requested by CG. CG CA Remarks 9. Complaints Acknowledge any complaints from CG or patients of CG concerning quality of supplied product or service within 48 hours Investigate and document any complaint within 2 weeks. This document should include details of all corrective and preventative actions
Qualification/Validation of transport of Products from place of dispensing to patients of CG Store and distribute all Products under appropriate conditions in compliance with requirements and any licence requirements Maintain the integrity of the cold/ambient chain. Distribute to patients in a timely way as described in the contract specification and service level agreement. Maintain an audit trail to the patient. This should include both product and delivery details e.g. batch numbers and delivery times. CG CA Remarks 7. Documentation Ensure that prescriptions as well as records of procurement, dispensing and distribution are clear, readily available and retained for the period required by current legislation. Records shall ensure the traceability of the origin and destination of Products. Ensure written procedures are available to describe all operations that may affect the quality of the Products. E.g. dispensing and distribution Archiving of dispensing and distribution documentation Maintain a record of batch numbers of products procured, supplied or returned in the event of a recall (see section 10). Batch numbers for supply and return should be recorded to patient level. CG CA Remarks 8. Other Quality Control and Quality Assurance Make available evidence of closure of, and assigned risk rating for, regulatory body inspection reports as requested by CG. CG CA Remarks 9. Complaints Acknowledge any complaints from CG or patients of CG concerning quality of supplied product or service within 48 hours Investigate and document any complaint within 2 weeks. This document should include details of all corrective and preventative actions
9-technical-agreement-for-oral-chemo-neppg.docx