The aims of NHS pharmaceutical quality assurance services

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Chapter: Hospital pharmacy : Quality assurance

The quality of medicines and their management are vital for the NHS. There are important health gains to be achieved from the use of quality-assured, clinically effective medicines.


The aims of NHS pharmaceutical quality assurance services

 

The quality of medicines and their management are vital for the NHS. There are important health gains to be achieved from the use of quality-assured, clinically effective medicines. It is also important to manage the potential risks of using medicines which may be of an inappropriate quality and could result in poor efficacy and safety. As part of a team effort, the overall management of medi-cines requires specialist input from QA pharmacists and other QA staff. They can contribute an in-depth knowledge of the pharmaceutical sciences, formu-lation and stability, QA systems and the QC of medicines. Therefore, the key aims of pharmaceutical QA services are assuring the quality of medicines and minimising the risk to NHS patients of receiving defective medicines. These aims are achieved by applying appropriate systems of QA, audit and QC to the purchasing, manufacturing and preparation of medicines in hospitals.

 

Pharmaceutical QA services include:

 

·      development, issue, implementation and monitoring of standards and guidance relating to quality aspects of hospital pharmacy services and the management of medicines

 

·      QA and QC of medicines purchased or manufactured prepared for hospital patients

 

·      quality audit of pharmacy technical services

 

·      investigation and testing of defective medicines

 

·      advisory services on all aspects of pharmaceutical QA and QC

 

·      R&D, especially in the areas of pharmaceutical formulation and stability studies

 

·      QC of medical gas installations in hospitals

 

·      training of pharmacy staff

 

·      laboratory and environmental testing services.

 

NHS QA services are coordinated nationally by the NHS Pharmaceutical Quality Assurance Committee, which includes regional QA pharmacists from throughout the UK. In addition to coordinating QA services, the Committee also develops and issues policy, standards and guidance on a range of pharma-ceutical QA issues. It operates a communications network at national and local levels, provides leadership and collective expert views, develops and promotes best practice and educational programmes and assists in maximising the effi-cient use of QA resources by sharing information. This information sharing includes the Analytical Information Centre database containing summarised test data from all regional laboratories, and reports of stability studies carried out in QC laboratories across the UK. The Committee has close working relationships with pharmaceutical advisers, the Medicines and Healthcare products Regulatory Agency (MHRA), the General Pharmaceutical Council, Royal Pharmaceutical Society and other key national bodies and agencies.

 

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