Process and GMP Audit

Services / Factory Audit

Process and GMP Audit

Review hygiene, contamination control, formula/batch control, critical processes, traceability and release for the product risk.

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Factory Audit

When it fits

For cosmetics, personal care, food-related, medical-related or client-specified critical processes.

Process and GMP Audit

Review hygiene, contamination control, formula/batch control, critical processes, traceability and release for the product risk.

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CONTROL POINTS

Core checks

Product risks and target-market requirements are translated into four verifiable control points.

Inspection objectiveProcess and GMP Audit

Product risks and target-market requirements are translated into four verifiable control points.

01

Zoning, personnel/material flow, hygiene and pest control

02

Materials, formula, batch, weighing and mix-up prevention

03

Critical parameters, equipment cleaning and process validation

04

Traceability, retention samples, release, complaints and recall

REFERENCE FRAMEWORK

Typical references

The applicable standard, regulation edition and route are confirmed against the product, target market and technical review at project start.

Applicable product GMP or industry code
Frameworks such as ISO 22716 only where product and market require
Client procedures, formula and risk-control requirements

CONTROLLED WORKFLOW

How the service works

01

Confirm audit objective and scope

02

Prepare checklist and review basic files

03

Interview, tour and sample records on site

04

Grade findings and capture evidence

05

Issue corrective direction and report

WHAT TO PREPARE

What you should prepare

Factory profile and business records
Organisation and headcount
Quality manual and procedures
Equipment and capacity data
Client checklist if applicable

WHAT YOU RECEIVE

Deliverables

Confirmed scope and document gaps
Structured check data and step-bound photos
Risks and points requiring human confirmation
Reviewed formal report or technical deliverable

AI ASSISTED, HUMAN CONTROLLED

AI support and human accountability

AI organises records and evidence, finds contradictions and drafts a finding summary. The auditor decides the facts and grading.

Boundary

AI does not change field facts, replace applicability judgement or approve the final report.

FAQ

Frequently asked questions

Can I request service with incomplete information?

Yes. Share the product, market, date and risks you know. The service manager will identify gaps; unconfirmed information is never converted into a field fact.

Does AI issue the final conclusion?

No. AI organises files, finds contradictions and flags missing evidence. Relevant professionals own field facts and final technical decisions.

When will the plan be confirmed?

Normally within one business day after sufficient information is available. Testing and certification timing depends on the exact project.

Tell us the product and target market. The right workflow will take it from there.

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