According to the Code of Federal Regulations (21 CFR 211.42 Design and construction features), 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 easy cleaning and maintenance, and proper operations.Ā Buildings should also be, maintained in a state of good repair.
A company recently received the following observation:
ā¦.. Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction and location to facilitate cleaning, maintenance, and proper operation.
Specifically,
a. … lots are first manufactured in a multipurpose manufacturing room. An API, …, is subsequently added into the blend outside of the multipurpose manufacturing room in an uncontrolled area under a debris-covered window. Prior to the mixing, the window is opened, a stained portable fan is placed on the debris-covered windowsill, and the stained portable fan is surrounded by several cardboard pieces to create a temporary hood (for isolation). The fan is used to address the fumes generated during the mixing process of the … in an open container. No cleaning records were available for either the uncontrolled area or the multipurpose manufacturing room. The window appeared stained and visibly unclean during the inspectional walkthrough of the facility.
b. An approximately 1.5 feet long separation from the drop ceiling was observed directly above the production table in the multipurpose manufacturing room where routine manufacturing (i.e., …) of … takes place.
c. A dead insect (approximately an inch in length) was found on the floor in the multipurpose manufacturing room during the walkthrough where routine manufacturing of … takes place. Your firm had recently completed the manufacturing of … lots #… and lot … in the room where the dead insect was found. … is a nasally administered OTC drug product.
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 buildings, refer to the following GMP TrendsĀ® Issues: 1129, 1125, 1115 and 1114.
For more observations pertaining to manufacturing controls, see our new Issue 1131 available today. It also has observations pertaining to quality systems, APIs and medical devices.
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