As-Built Drawings – A set of architectural drawings that are marked-up by a contractor building a GMP production or testing facility to show how the facility was actually built versus the way it was originally designed.  

Why it Matters – GMP production and testing facilities are often modified or expanded to increase the size of labs, manufacturing or warehouse areas, or add new GMP utilities such as systems for purified water, clean steam generators, or large nitrogen storage tanks.  The as-built drawings must be updated (or redrawn) each time changes are made because they provide critical information that contractors use to tie into existing plumbing, drainage, electrical, heating/cooling, and gas systems.

Case Study – A Contract Development and Manufacturing Organization (CDMO) installed three new environmental chambers for use in GMP stability studies for their sponsors.  After facilities personnel plugged each chamber into electrical outlets labeled e-power (e.g., emergency power) and connected data monitoring cables, the equipment manufacturer validated each chamber using approved protocols.   Following Quality Assurance (QA) approval of the executed protocols, Quality Control (QC) transferred GMP samples from multiple sponsors into the new chambers. 

In the middle of the night two months later, the entire city block lost electrical power for about 9-hours.   When the facilities manager drove into the parking lot the next day, he noticed that the emergency generator was running.  Concerned, he walked through the GMP labs and noticed that the temperature and humidity displays on all of the new chambers were blank while the displays on the older chambers were illuminated and operating within their acceptable ranges.  He then made two phone calls: one to notify the QC director and the other to an electrical contractor.  

An electrician inspected the panel supplying electricity to the chambers, physically tracing the cabling from the outlets the chambers were plugged into to the source panel.  He quickly determined that the electrical panel was not connected to emergency power. The as-built drawings provided to the electrician, however, showed that the source panel was connected to e-power.  He communicate the conflict to the facility manager and watched his facial expression go from concern to panic.  

The CDMO was obligated to notify each effected sponsor and initiate a impact assessment for all of the products in the new chambers.

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