Qualification of old installations in 2025

Until the revision of Annex 15 in October 2015, Annex 15 contained a separate chapter on the topic of qualification of existing installations. This chapter was omitted in the new version. But how do you deal with the qualification of an old installation nowadays?

Requirements of the ‘old Annex 15’

The original passage in the old Annex 15 was entitled ‘Qualification of existing (in use) facilities, systems and equipment’. The requirements at that time were

• Data supporting and verifying the operating parameters and limits for critical variables
• Calibration procedures and records
• Cleaning procedures and records
• Maintenance procedures and records
• Operating procedures and records
• Operator training procedures and records

What about today?

The above points from the old Annex 15 certainly still apply today in the case of an old installation qualification. And such an old installation qualification can still occur today. For example, there are cases where a non-GMP area becomes a GMP area with the equipment already present there. Or a used system is purchased that has no/hardly any qualification documents. In both cases, an equipment qualification is necessary at the new site.

The following recommendations come from two Concept seminars about equipment qualification.   

Many documents are often no longer available for an old installation. However, with the introduction of lifecycle models, a User Requirement Specification (URS) must now be available also for an old installation as it is the reference point in the qualification lifecycle. This means that the URS must also be created retrospectively. The basis for this is the products that are 'run' on these installations. A risk analysis should be used to determine which measurement points are relevant for calibration. Ideally, the technical documentation (P&I diagrams, instrumentation and control documentation, etc.), if available, will be compiled and attached to the qualification documents.

Qualification Activities

It is also advisable to carry out preliminary tests on old installations if possible. Even if you think you know the installation well, the acceptance criteria you choose may be too narrow.

Otherwise, the procedure is then continued according to a new installation, based on a risk analysis:

• Define acceptance criteria (possibly complemented by field reports)
• Create and approve qualification protocols
• Conduct qualification (product-related)
• Create and approve qualification report
• Integrate the installation into the life cycle as qualified (change control, maintenance, monitoring, re-calibration, re-qualification)

Conclusion: Old installations should be qualified as close as like a new installation, where this makes sense. If user requirements do not exist, they must be created retrospectively.