In these unprecedented times, product safety systems will be pressurised and it will be tempting to cancel activities such as internal audits to prioritise production activities. However, it is even more vital than normal that sites ensure good product safety practices, and the internal audit programme is a very powerful self-help tool in this respect, to verify ongoing product safety practices. Therefore, internal audits should never be cancelled.

However, revisiting the internal audit risk assessment schedule at this time, is extremely valuable. The risk assessment used to create the original plan (clause 3.4.1) should enable sites to identify those most critical systems, the failure of which would have significant impact in terms of product safety, integrity or legality. Clear priority can then be given to the scheduling and completion of the identified critical items. Internal audits on systems with less impact can then be reviewed and where appropriate re-scheduled for later in the year.

GMP inspections (clause 3.4.4) can also be reviewed, but it should be remembered that where a site has introduced changes to their cleaning and maintenance schedules, pest control management, cleaning materials, etc. this will need to be verified to ensure effectiveness.

Sites may also need to adapt their normal ways of working, for example:

  • identifying alternative auditors, if there are staff shortages, or if contractors are normally used but are no longer allowed onsite
  • effective alternative audit techniques, for example, could documentation systems be completed using remote audits


In conclusion, sites need to continue to meet the requirements of section 3.4 of the Standard because this will facilitate vital verification that product safety systems continue to operate effectively and as intended.