activity, these constituents must also be specified and quantitatively determined. If a herbal remedy contains several vegetable drugs or preparations of several vegetable drugs and it is not possible to perform a quantitative determination of each active ingredient, the determination may be carried out jointly for several active ingredients. The need for this procedure must be justified. Annex 11 Computerised systems – PE 009-10 PE 009-08 Nature of Estimated impact significance of impact Principle Principle Rewrite Minor highlighting the This annex applies to all forms of computerised systems The introduction of computerised systems into systems of pre-existent used as part of a GMP regulated activities. A manufacturing, including storage, distribution and quality requirement to computerised system is a set of software and hardware control does not the need to observe the relevant validate components which together fulfil certain functionalities. principles given elsewhere in the Guide. Where a computerised computerised system replaces a manual operation, there systems and The application should be validated; IT infrastructure should be no resultant decrease in product quality or qualify IT should be qualified. quality assurance. Consideration should be given to the risk infrastructure
activity, these constituents must also be specified and quantitatively determined. If a herbal remedy contains several vegetable drugs or preparations of several vegetable drugs and it is not possible to perform a quantitative determination of each active ingredient, the determination may be carried out jointly for several active ingredients. The need for this procedure must be justified. Annex 11 – Computerised systems PE 009-10 PE 009-08 Nature of impact Estimated significance of impact Principle This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfil certain functionalities. The application should be validated; IT infrastructure should be qualified. Principle The introduction of computerised systems into systems of manufacturing, including storage, distribution and quality control does not the need to observe the relevant principles given elsewhere in the Guide. Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality or quality assurance. Consideration should be given to the risk Rewrite highlighting the pre-existent requirement to validate computerised systems and qualify IT infrastructure Minor
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