Quality Assurance Services, Chelsea and Westminster Hospital NHS Foundation

- Document approval and GMP Audit – One internal audit per year and support with the preparation of the external audit and be available on the day of the audit - Support with relevant action plans from external audit - Quality Management Review including specialist advise and clarifications - Site visits, monthly meetings and specialist information. Monthly review of quality exception reports and change controls - Review errors and provide advice - Review of microbiological data reported including microbiological excursions. - Approval of microbiological excursion investigation reports and advice on appropriate course of action(s) in the event of such excursions. - Specialist advice and support - Releasing UMP and Specials, dealing with defects and recalls for all products including imports and specials which come into the pharmacy

For environmental monitoring , work required will cover the following, although this is not an exhaustive list: - Provision of micro plates, Broth and all required media - Receipt, incubation, reading. Evaluation and electronic reporting of microbiological environmental monitoring plate results - Bacterial identification to species level - Validation samples - Quarterly visit to complete MEM monitoring - Annual Broth GPT (Growth Promotion Testing) of broth used for operative or process validations - Quarterly contract review meetings - Staff training - Client audit of Local QC - Fridge mapping when required - Transporting samples - Air sampling - Particle counts

This lot is for suppliers that can offer the services covered within Lots 1 and 2. QMS - Document approval and GMP Audit – One internal audit per year and support with the preparation of the external audit and be available on the day of the audit - Support with relevant action plans from external audit - Quality Management Review including specialist advise and clarifications - Site visits, monthly meetings and specialist information. Monthly review of quality exception reports and change controls - Review errors and provide advice - Review of microbiological data reported including microbiological excursions. - Approval of microbiological excursion investigation reports and advice on appropriate course of action(s) in the event of such excursions. - Specialist advice and support - Releasing UMP and Specials, dealing with defects and recalls for all products including imports and specials which come into the pharmacy. For environmental monitoring, work required will cover the following, although this is not an exhaustive list: - Provision of micro plates, Broth and all required media - Receipt, incubation, reading. Evaluation and electronic reporting of microbiological environmental monitoring plate results - Bacterial identification to species level - Validation samples - Quarterly visit to complete MEM monitoring - Annual Broth GPT (Growth Promotion Testing) of broth used for operative or process validations - Quarterly contract review meetings - Staff training - Client audit of Local QC - Fridge mapping when required - Transporting samples - Air sampling - Particle counts