Good Manufacturing Practice Maintenance
Good Manufacturing Practice maintenance is the controlled upkeep of facilities, utilities, and equipment so they remain suitable for producing safe and conforming products.
What this term means in maintenance
Good Manufacturing Practice maintenance is the controlled upkeep of facilities, utilities, and equipment so they remain suitable for producing safe and conforming products.
Maintenance under GMP
GMP maintenance commonly emphasizes:
- Equipment condition
- Cleanability
- Contamination control
- Calibration
- Approved materials
- Documentation
- Change control
- Contractor control
- Temporary-repair control
- Qualification and validation
Practical example
A product-contact gasket is replaced with an approved material. The work order records the part, technician, cleaning, inspection, and release before production resumes.
Documentation expectations
Records should show the asset, work performed, date, parts, materials, responsible users, inspection results, deviations, and approvals.
Maintenance and change control
Changes to parts, software, settings, or design may require formal assessment and approval before implementation.
Common mistake
Using undocumented substitute parts or uncontrolled temporary repairs can compromise product quality and traceability.
Related concepts
Related maintenance terms
Keep exploring connected CMMS, reliability, and maintenance planning terms.
Document Control
Document control is the process used to approve, issue, revise, distribute, review, and withdraw procedures, instructions, drawings, and other controlled information.
Validation
Validation is the confirmation, using objective evidence, that a process, method, system, or result is suitable for its intended use.
Maintenance Record
A maintenance record is evidence of maintenance work, inspection, calibration, testing, decision, or equipment condition associated with a specific asset or activity.
Glossary FAQs
- What is GMP maintenance?
It is controlled upkeep of equipment and facilities so they remain suitable for producing safe and conforming products.
- Why is documentation important under GMP?
It provides evidence of work, parts, materials, tests, deviations, changes, and approval.
- Can substitute parts be used?
Only when assessed and approved according to applicable quality and change-control requirements.