Maintaining your facility (both the buildings and the equipment), is an important part of pharmaceutical manufacturing. Failure to maintain your facility can result in multiple citations during an FDA inspection, as seen here in this companies recent FDA inspection.
According to the Code of Federal Regulations (21 CFR 211 Subpart C – Buildings and Facilities), any building(s) used in the manufacture, processing, packing, or holding of a drug product should be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations. There should be adequate lighting, ventilation, air filtration, heating and cooling. Buildings should also be, maintained in a state of good repair.
A company recently received the following observation:
…. Failure to properly maintain equipment, buildings and facilities used in the manufacture of intermediates and API in a clean condition.
Specifically, several cleaned equipment used for manufacturing were found not stored properly. General cleanliness and maintenance of facility is not well maintained throughout the manufacturing areas. For example.
a. Filter … and … were stored behind the facility in open environment near open drainage area and wastewater collection area. The usage logs did not ensure that these equipment were cleaned prior to use.
b. Air conditional condensate is drained to the equipment washing room for the warehouse, which kept the area continuously wet. The washroom is used to clean the dispensing tools, used for sampling and dispensing raw material components. We observed mold-like black appearance throughout inside the sink. A live black worm was observed moving around the floor, near the drainage outlet of the equipment washing area.
c. Section …. intermediate manufacturing plant was observed to have significant number of flying insects, flying over the open … and over the cleaned equipment. In addition, chipped floor and stagnant water were observed throughout inside the … room.
d. Water leak from the sink was observed in the hand wash area, within the … handling room (Class 100,000 room) of manufacturing Section … Water was observed on the door of the gowning room.
For additional information on facility and equipment requirements, refer to FDA presentation: Facilities and Equipment: cGMP Requirements and guidance document: Q7 Good Manufacturing Practices for Active Pharmaceutical Ingredients.
To view more observations pertaining to facilities, refer to the following GMP Trends® Issues: 1125, 1116, 1114 and 1109.
For more observations pertaining to manufacturing controls, see our new Issue 1126 available today. It also has observations pertaining to quality systems, APIs and medical devices.
Stay in Compliance! Subscribe today!
Recent Comments