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Increase Integrity of Single-use Assemblies Immediately Before Use.
ATMI Life Science
The European Commission has updated its annex covering computerisation of process control, documentation and data-processing systems to take into account developments in the field.
With computerisation becoming increasingly prevalent in these areas the EU is keen to ensure that the levels of monitoring and documentation do not slip.
The current annex covering computerisation is based around national guidelines implemented in the 1980s and consequently the sector has evolved beyond the annex's scope.
The concern is that with increasing levels of automation people will become less vigilant in their adherence to the guidelines laid down in the EU's good manufacturing practice (GMP) for pharmaceuticals.
Consequently a services group was formed with a remit to overhaul annex 11, covering computerisation, and make amendments to chapter four, covering documentation, to account for the rise in computerisation and electronic records.
The result is that policies and plans for the validation of computerised systems must be put in place by the manufacturing authorization holder. Included in this must be up to date listings of systems and their GxP (good clinical, laboratory and manufacturing practice) functionality.
More complex computerised systems will be required to undergo a more extensive validation process. Bespoke or significantly customised computerised systems require a policy of formal assessment to be in place, which monitors the quality and performance of the system and software at all stages from inception to retirement.
Documentation of all this is required, with the EU wanting manufacturing authorization holders to have audit trails which enable them to defend their standards and protocols.
The updated annex also includes guidelines for ensuring the security of the computerised system, be that through keys, pass cards, personal codes with passwords or biometrics.
In addition the draft covers the storage and backing up of data to mitigate against losses.
Continuing adaptation to developments is necessary for GMP to remain relevant and the EU has been keen to stay on top of matters.
This latest draft follows on from International Conference on Harmonisation (ICH) Topic Q10 which updated the guidelines regarding the implementation of an effective pharmaceutical quality management system.
A concept paper for the revision of annex 11 was published back in December 2006 and there is still some way to go before the final draft is settled upon.
Interested parties have until 31 October to communicate their comments. Copies of the relevant documents can be found here and here .
