Glossary
Preventive Maintenance (PM)
Inspecting and servicing equipment to a predetermined schedule and procedure, rather than repairing it after it has failed.
Source · ICH Q7 (2000), §5.2 Equipment Maintenance and Cleaning, ¶5.20
Details
The name resembles the preventive action of CAPA but the object is different: this is the planned inspection and servicing of equipment, and ICH Q7 requires the schedule and procedures to name who is responsible. The corpus includes cases with no preventive maintenance programme at all, including filter inspection and replacement, inadequate tank maintenance, and a firm required to both carry out repairs and keep to the maintenance schedule. Because 21 CFR 211.67(c) requires records of maintenance, cleaning, and inspection, compare the planned interval with the history of what was actually done.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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You use (b)(4) for cleaning drug manufacturing equipment, and the same system feeds your (b)(4) system.
FDA · FDA Warning Letter · 2026-07-14 -
Equipment used in the manufacture of terminally sterilized drugs at your facility is not designed or maintained appropriately.
FDA · FDA Warning Letter · 2023-08-01 -
Lack of Process Validation Your firm failed to adequately validate your manufacturing process for each of your OTC drug products and qualify the manufacturing equipment used for their production.
FDA · FDA Warning Letter · 2026-01-20
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q7 (2000), §5.2 Equipment Maintenance and Cleaning, ¶5.20GRM Regulatory Glossary
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