Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP) is a system of standards and guidelines that ensures products are consistently manufactured, tested, and controlled according to quality benchmarks. GMP covers personnel training, facility hygiene, equipment maintenance, process documentation, and traceability. Regulatory bodies such as the TGA in Australia and the FDA in the United States enforce GMP requirements across pharmaceuticals, food, cosmetics, and medical devices.
Why it matters
Non-compliance with GMP can result in product recalls, regulatory shutdowns, and serious harm to consumers. Equipment that is poorly maintained, uncalibrated, or missing documentation creates audit failures and production holds. Organisations that embed GMP into daily operations reduce the risk of costly non-conformances and protect both public safety and brand reputation.
How MapTrack helps
MapTrack supports GMP compliance by tracking calibration schedules, maintenance records, and inspection history for every piece of production equipment, with audit-ready reports available on demand.
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Frequently asked questions
What does GMP cover in a manufacturing environment?
GMP covers personnel hygiene and training, facility and equipment cleanliness, documented procedures for every production step, raw material traceability, in-process and finished product testing, and record-keeping. It requires that all equipment used in production is properly maintained, calibrated, and validated so that it performs consistently within defined tolerances.
How does equipment maintenance relate to GMP?
GMP regulations require that production equipment is maintained in a clean and orderly condition, serviced at appropriate intervals, and calibrated to verified standards. Maintenance records must be retained as part of the GMP documentation system. A missed service or an out-of-calibration instrument can invalidate an entire production batch and trigger a regulatory non-conformance.
Who enforces GMP in Australia?
The Therapeutic Goods Administration (TGA) enforces GMP for pharmaceutical and medical device manufacturers in Australia. Food Standards Australia New Zealand (FSANZ) sets food safety standards, while state and territory authorities conduct inspections. Manufacturers must pass regular GMP audits to maintain their licence to produce and supply regulated products.
Related terms
Standard Operating Procedure (SOP)
An SOP is a documented, step-by-step set of instructions that standardises how a routine task or process should be performed. In asset management and maintenance, SOPs ensure consistency, reduce errors, and support compliance with safety and regulatory requirements. They cover everything from equipment start-up procedures and inspection protocols to maintenance workflows and emergency response steps.
Calibration
Calibration is the process of comparing the measurements produced by an instrument or device against a known reference standard and adjusting it to ensure accuracy within specified tolerances. It applies to test and measurement equipment, sensors, gauges, safety devices, and any instrument where measurement accuracy is critical. Calibration records include the as-found and as-left readings, the reference standard used, and the calibration date and next due date.
Compliance Management
Compliance management in asset-intensive industries is the systematic process of ensuring that equipment, operations, and personnel meet all applicable regulatory, safety, environmental, and contractual requirements. It encompasses tracking inspection due dates, certifications, licences, safety checks, environmental obligations, and industry-specific standards. Compliance management requires both proactive scheduling and thorough record-keeping.
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