For manufacturing & assembly facilities
GMP Consulting for Medical Device Manufacturing
Manufacturing compliance is decided on the production floor, not in the document library. We align your facility, processes and records so that what you have written down is exactly what an assessor observes happening.
- Primary outcomeProduction controls that pass assessment first time
- Focus areasCleanrooms, validation, batch records, QA release
- Best fitNew facilities, scale-ups and post-audit remediation
Good Manufacturing Practice is where quality documentation meets physical reality. An assessor walking your production floor is checking one thing above all: does the operation in front of them match the system described on paper? Most manufacturing findings trace back to that single gap.
What GMP Consulting covers
Deliverables are adjusted to your device class, facility type and audit timeline — this is the full menu.
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Manufacturing facility layout
Flow-of-materials and flow-of-personnel design, segregation of clean and dirty zones, pressure cascades and change-room configuration reviewed before you build.
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Cleanroom compliance
Classification selection, HVAC and HEPA qualification, environmental monitoring programmes, gowning protocols and routine requalification schedules.
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Process validation
IQ / OQ / PQ protocols and reports, sterilisation and packaging-seal validation, statistical sampling rationale and revalidation triggers.
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Batch records & documentation
Device Master Record and Device History Record structure, batch manufacturing records, good documentation practice training and record-retention policy.
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Quality assurance systems
Incoming inspection, in-process controls, final QA release authority, non-conforming product handling and rework controls with clear decision rights.
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Equipment & calibration
Preventive maintenance schedules, calibration programme with traceable standards, and out-of-tolerance impact assessment procedures.
Who this is for
- Manufacturers commissioning a new production facility or cleanroom
- Contract manufacturers taking on medical device work for the first time
- Established plants scaling from pilot to commercial volumes
- Facilities remediating manufacturing-related audit findings
- Companies bringing previously outsourced production in-house
What you walk away with
- Facility gap assessment
- Validation master plan
- IQ/OQ/PQ protocol set
- Batch record templates
- Cleanroom monitoring plan
- QA release procedure
Every engagement follows our four-stage pathway
Initial assessment → QMS & dossier preparation → CAB/MDA audit → approval and renewal.
See the full pathwayGMP — frequently asked
01
When should we bring in a GMP consultant — before or after building the facility?
Before, without question. Flow-of-materials, flow-of-personnel, pressure cascades and change-room placement are structural decisions. Correcting them after construction means rebuilding walls and re-balancing HVAC, which is dramatically more expensive than getting the layout right at design stage.
02
What is the difference between IQ, OQ and PQ?
Installation Qualification confirms equipment is installed correctly and to specification. Operational Qualification demonstrates it performs across its intended operating ranges. Performance Qualification proves the process produces conforming product consistently under real production conditions. Assessors expect all three, documented in that order, with a rationale for the ranges you chose.
03
Does GMP replace ISO 13485 for manufacturers?
No — they address different things and typically operate together. ISO 13485 is the overarching quality management system standard. GMP concerns the manufacturing controls within it: facility, environment, process validation and production records. A manufacturer generally needs both working as one integrated system.
Disclaimer: The content above is general information, not regulatory or legal advice. Requirements, fees and validity periods are set by the Medical Device Authority and may change. Always verify current requirements against the applicable MDA guidance documents, or engage us for a formal assessment of your specific case.
Ready to start your GMP project?
A 30-minute call with Maya establishes what applies to your business, what it will take, and how long it should realistically run.