National Health Service (NHS) regional quality control (QC) laboratories were first established in 1966 following health memorandum HM(65)22. This dealt with the QC of purchased drugs and dressings, giving guidance to NHS regions on setting up regional QC services.
Quality assurance
National Health
Service (NHS) regional quality control (QC) laboratories were first established
in 1966 following health memorandum HM(65)22. This dealt with the QC of
purchased drugs and dressings, giving guidance to NHS regions on setting up
regional QC services. The aim was to ensure that the quality of the products
procured through the regional purchasing system met a satisfactory standard. In
the early 1970s the work of the laboratories was significantly extended
following HSC(IS)128 Application of the Medicines Act to Health Authorities,
which applied the principles of the Medicines Act to all pharmaceutical manufacturing
operations undertaken by health authorities. The circular required quality
assurance (QA) and QC arrangements to be in place for all such activities and
resulted in provision of QC laboratory facilities for each NHS manufacturing
unit, located in most major pharmacy departments. It also resulted in them
being subjected to regular inspection by the Medicines Inspectorate.
In 1984, health
circular HC(84)3 introduced a policy of costing hospital pharmaceutical
manufacturing operations and required the NHS to engage in manufacture only if
there was no satisfactory commercial source or if it was significantly more
economical to do so. This, along with the increasing commercial availability of
hospital requirements, resulted in the rationalisa-tion of both manufacturing
and QC laboratory facilities through the remain-der of the 1980s and the 1990s.
Some NHS regions took the view that QA and QC services should be provided
centrally at regional level, in order to make the best and most cost-effective
use of the specialist staff and laboratory resources; this resulted in regional
QC services based within one or two large laboratories on hospital sites within
their region.
Throughout the 1990s
and early 2000s there was a very large increase in the number of pharmacy
aseptic units preparing injections and other products, as well as an increase
in the preparation of clinical trial materials. NHS executive letters EL(96)95
and EL(97)52 introduced requirements for regular internal and external quality
audit of pharmacy aseptic preparation activities to ensure these services
achieved appropriately high standards. The require-ments established the role
of the regional QA specialist in performing these external audits. These
aseptic services, along with the remaining NHS manufacturing units, continue to
require specialist QA and QC facilities, as well as pharmacists and other QA
staff with substantial skills and knowledge in QA, good pharmaceutical
manufacturing practice, QC, audit, pharma-ceutical sciences and technology,
formulation and stability.
In the early 2000s
the Department of Health established the NHS Hospital Medicines Manufacturing
and Preparative Services Implementation Board, which oversaw the review of
hospital pharmacy manufacturing and associ-ated QA services, and then managed a
modernisation programme from 2004 to 2006. The programme included considerable
capital investment in facilities for these services. A risk management
programme involving product rational-isation followed, including implementation
of autoidentification (bar coding) systems, and the launch of a national
database (called Pro-File) of NHS-manufactured items.
Following
publication of the NHS next-stage review High Quality Care for All and the
government’s White Paper Pharmacy in England: Building on Strengths, Delivering
the Future in 2008, a new national strategy for NHS pharmaceutical services was
developed and issued by the NHS Pharmaceutical Quality Assurance Committee.
This gave details of the important roles that NHS pharmaceutical QA services
now play as part of the pharmacy team in assuring the quality of medicines in
the NHS from procurement or prepara-tion/manufacture through to their final
point of use by patients.
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