Principles of Asceptic Processing and Packaging

Product Information

Auditor closely monitors progress with action plans and QIs until service is removed from compliance management. CQC is the independent regulator of health and adult social care in England. It makes sure health and social care services provide people with safe, effective, compassionate, high quality care and encourages care services to improve. We support pharmaceutical and medtech companies, leveraging our expertise in injection molding and manufacturing of the ready-to-use devices. We are member of SKAN Group. And together we are always one step ahead.

ASEPTIC | definition in the Cambridge English Dictionary

recognise the positive impact of ready-to-administer (RtA) injectable medicines on critically ill patients

Patients able to receive their aseptic medicines at home or in the community are hugely appreciative of the freedom this gives them to get on with their lives as opposed to long stays in hospital. Good communication and co-production with patients is essential to help ensure that complex medicines supply and administration, such as chemotherapy, is not overly impacted by, for example, the clinical need to have recent blood tests to allow safe administration of their medicines. Optimal use of ready-to-administer standardised products available 'off the shelf' reduces delays. Direct pharmacy team involvement within clinics provide both clinical expertise and effective operational workflow planning and management to reduce delays and inconvenience to patients, whilst increasing clinical capacity. Examples of leaflets, posters and communications campaigns for these patients to improve their understanding and experience of their treatment were supplied in the call for evidence. Good practice in this area should be shared within the proposed networks for aseptic services. Invest in becoming an early adopter of innovation and support the development of the next generation of improvement technologies to future proof services and align with NHS industrial strategy through strategic partnerships with innovators. R&D and clinical trials

Aseptic Processing Programme - TSET Aseptic Processing Programme - TSET

To seek assurance that the governance and assurance arrangements for aseptic services are in place.For the purposes of this guidance, ‘aseptic preparation of medicines’ focuses on activity performed within an aseptic facility with pharmacy oversight. This definition therefore encompasses reconstitution of injectable medicines when undertaken within NHS pharmacy aseptic facilities in England. For the avoidance of doubt, reconstitution of injectable medicines in clinical areas is out of scope of this guidance. It also describes the oversight provided by the Care Quality Commission (CQC) and the inter-relationships between the regulatory bodies, primarily the CQC, Medicines and Healthcare products Regulatory Agency (MHRA) and General Pharmaceutical Council (GPhC). 2. Introduction SPS QA produces a quarterly regional situation report to provide an overview of the status of all NHS pharmacy aseptic facilities in the appropriate NHS region. Reports are distributed to all NHS England regional chief pharmacists. For further detail about iQAAPS, see Appendix 1. 8. Assurance and performance management Quality indicators (QIs)