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.
- 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.
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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