Evolution of computerised system use has outdated some aspects of the existing legislation prompting the European Union (EU) to revise the document. Modifications to the legislation are intended to ensure effective introduction of computerised systems to manufacturing processes.
“Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality or quality assurance”, says the opening statement of the revised legislation. The legislation is due to come into force in the EU in June.
Annex 11 was developed by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and as such its influence may extend beyond the EU, according to David Hawley, director, LifeSciences, North America at Business & Decision.
Speaking in an online presentation Hawley said “it is a matter of time” until PIC/S, which is made up of regulatory authorities and partnered with the World Health Organization (WHO), adopts the revised Annex 11 into its documents.
Adoption by PIC/S would extend the influence of Annex 11 beyond the EU. The influence of the document may also, over time, extend beyond pharma manufacturing and into other areas, such as distribution, said Hawley.
Revisions
Industry responses to an earlier consultation document have, to a large extent, been taken into account by the final draft, said David Stokes, global head of life sciences at Business & Decision. Stokes was speaking at the same online presentation as his colleague Hawley.
Some of the changes to the “outdated” document bring it inline with current practices. For instance, the revised legislation removes the “obsolete” requirement of running computerised systems in parallel with manual operations.
However, some companies may need to assess aspects of their operations in light of the revisions. The legislation is the first instance of clear guidance IT infrastructure should be qualified, said Stokes, and some companies may still need to perform this process.