Buildings and/or equipment must be properly maintained. According to the Code of Federal Regulations (21 CFR 211.58 Maintenance), any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair.
A company recently received the following observation:
….. Buildings and equipment used in the manufacture of APIs are not properly maintained.
Specifically,
- There is no door or adequate protective screening of the catwalk adjacent to the … conveyor in the back of the …. area which protects and restricts potential introduction of contamination from filth or infestation of animals/pests inside the manufacturing plant. The current protection of a rectangular piece of cloth suspended by a black cable tied to the utility lines is insufficient and not GMP.
- The exhaust line to the … used to remove … fine particle dust became so clogged that the blockage caused the blowback of … fine powder on the main API production plant floors, handrails, equipment, control panels, and personnel. Production was not halted until a … was performed.
- I observed liquid leaking from a pipe fitting …, identified as a liquor (saturated … solution) transport line, adjacent to the … which transports purified wet … to the ….
For more information on how to maintain a proper facility, refer to the following: FDA’s Investigations Operations Manual Issued 2021, Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Issued September 2016 and FDA’s Regulatory Education for Industry Presentation: Facilities and Equipment cGMP Requirements.
To view more observations pertaining to buildings and facilities, refer to the following GMP Trends® Issues: 1036, 1043, 1051, 1056 and 1058.
For more observations pertaining to APIs, see our new Issue 1068 available today. It also has observations pertaining to quality systems, manufacturing controls, and medical devices.
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