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The PIC/S Guide to Good Manufacturing Practices is the basis for GMP
inspections. In particular its Annex 11, ‘Computerised Systems’ is used when
inspecting such systems.
The purpose of this document is to provide recommendations and background
information concerning computerised systems that will be of assistance to
inspectors for training purposes and during the inspection of computerised
systems. The document will be of assistance to all ‘Good Practice’ Inspectors
responsible for inspecting applications in the regulated pharmaceutical sector1 ;
hence the use of the acronym ‘GxP’ in the title. It is recognised that not all
companies subjected to GLP inspections are linked to the regulated
pharmaceutical sector. However, it is considered that the guidance contained
within this PIC/S document may also be beneficial to companies subjected to
other regulatory frameworks and GLP inspection.
GDP defines the scope of compliance requirements for wholesaling and
distribution practice. Where automated systems and electronic records are used
for such applications then inspectors will expect such regulated users to have in
place the sorts of controls and disciplines outlined in this document, or a best
practice alternative. Vertically integrated companies (R&D, manufacturing and
distribution) will already apply such controls and compliance measures.
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International regulatory agencies have collaborated to produce this harmonised
guidance for the implementation, management and operation of computerised
systems. It is intended as a reference for regulated users, including their
suppliers, in addition to regulatory inspectors and investigators.
This guidance document is intended to provide a logical explanation of the
basic requirements for the implementation, validation and operation of
computerised systems. Additionally, the document may be adapted to identify
the criteria that would be expected to be considered if a regulated user, or a
regulatory agency, were to conduct an inspection of the implemented
computerised system(s), against GxP compliance requirements and/or
This guidance document provides details of good practices, which should
support new technology and technical innovations.
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