What does the FDA expect regarding Facility Maintenance?

In the news The GMP Relevance of Equipment Maintenance from FDA's Perspective, you could already read about deficiencies in equipment maintenance. A separate section of the US GMP regulations (21 CFR 211.58) also requires 'maintenance' of the premises. And this is precisely what the FDA criticised the manufacturer for, referring specifically to 21 CFR 211.58: 'Your firm failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair'.

Objections of the FDA

The FDA criticised:

• Gaps in the protective wall surrounding the original wall surface in the machine room. This leads to areas that are difficult to clean.
• An unknown brown-yellow material was visible in wall gaps near the equipment. This indicates potential contamination risks in the production environment.
• A ceiling vent in the tablet room was improperly secured with transparent adhesive tape. From the FDA's point of view, this indicates inadequate maintenance of the facility.
• The walls of one room were unfinished and could not be cleaned.

Remedial measures taken by the drug manufacturer

The pharmaceutical manufacturer promised to immediately halt all production processes and to take immediate corrective and preventive measures to remedy the specific deficiencies. It also promised not to resume production until all repairs had been completed and the premises met the required standards of cleanliness and maintenance.

Further FDA measures

This is also insufficient for the FDA. It additionally requires:

• A CAPA plan for implementing routine and effective monitoring of facilities and equipment. Among other things, this plan should ensure the immediate detection of problems with equipment and facilities. It should guarantee the effective implementation of repairs and compliance with appropriate preventive maintenance plans. Similarly, timely technological upgrades to equipment and facility infrastructure should be incorporated into the CAPA measures, as well as improved systems for monitoring by management.
• Documented evidence (e.g. photographs) of all repairs carried out on facilities and equipment.

There were similar deficiencies in the last three FDA inspections and the pharmaceutical manufacturer's assurance to address them, according to the FDA. The fact that deficiencies occur repeatedly shows the FDA that senior management oversight is inadequate. 

Conclusion: Maintenance affects not only equipment but also premises - and: Ultimate GMP responsibility lies with senior management.

As usual, please visit the FDA website for the entire Warning Letter.