Pharmaceutical Construction Sites: Dealing with Documents in Piping Construction

Constructing a pharmaceutical plant, including the necessary pipework for black and pure media or products, comes before GMP operation. Even if cleanliness should be regulated on 'pharmaceutical construction sites', clean conditions do not prevail here.
So how should you deal with documents that have oil stains typical of construction sites or have been partially soaked?

To clarify this question, it should first be checked to what extent construction documents such as isometric drawings fall within the scope of GMP or GEP (Good Engineering Practice). This may vary from project to project, but also for each site.
It is often not possible to record all variants in an overarching document in advance. Plant manufacturers usually have standards - which they then handle more or less flexibly.

A typical procedure, which applies to approx. 35% of GMP clean media pipework systems/projects, is that 2D routing (pipe route in the floor plan with points for the acceptance points) and the P&ID are sufficient for qualification. A prerequisite is the completeness and correctness of the P&IDs, including detachable connections, room boundaries and gradients. In such cases, the isometric drawings of GMP pipes can be categorised as 'GEP only'. Documents with oil and water stains or 'construction dirt' can be accepted as GEP documents - as long as they are still legible and complete. In order to have a complete set of documents available electronically, these GEP isometrics should then also be marked 'as built', scanned and properly filed.
Around 35% of systems/projects now have good 3D plans, which contain the isometrics. In some cases, these are no longer printed out.
The remaining 30% of systems/projects have variants/mixtures, e.g. manual or CAD isometrics.
A special case are the 'hook-up' isometrics for connecting package units to the supply and disposal systems. Due to requirements such as sampling, sterilisation, emptying, measuring devices or automation, these can sometimes be a separate design and documentation category.

The procedure of signing off soiled documents, such as isometric drawings, is possible. However, the process of converting working drawings into clean as-built documentation must be traceable in order to avoid transcription errors. This can be done, for example, by a second check and confirmation by signature.

It has also proven to be a good idea to keep the original working drawings in order to prove traceability if this should become necessary.

In summary:

• Whether GMP requirements apply to construction isometrics depends on the project and the system in question.
• All construction documentation must comply with GEP.
• Drawings used by an installer on site should be part of the 'as built' documentation. If these drawings are contaminated with oil, water or similar, this may be acceptable as long as they are legible.