GMP area walk-through
Daily manufacturing area walk covering line clearance, gowning, environmental conditions and documentation practice.
GMP
19 questions~30 mindaily
Typically run by QA Officer
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Pharma
Drug manufacturers, CDMOs, medical device makers, clinical labs and API producers.
The job you're hiring this for
Surviving a regulatory inspection with clean data integrity — no backdated records, every deviation investigated, every CAPA effectiveness-checked.
Weighted questions with auditor guidance, and on most of them the clause each question evidences — ready to run, or to edit into your own house standard.
Daily manufacturing area walk covering line clearance, gowning, environmental conditions and documentation practice.
Typically run by QA Officer
Reviews GxP data against ALCOA+ principles across paper and electronic systems — the focus of most recent regulatory citations.
Typically run by QA / Computer System Validation Lead
Pre-release review of a completed batch record for completeness, deviations, yield reconciliation and QA disposition.
Typically run by QA Reviewer / Qualified Person
Verifies cleaning procedures are validated to scientifically justified limits, with worst-case bracketing and swab recovery.
Typically run by Validation Lead / QA
Reviews whether deviations reach true root cause and whether CAPAs actually prevented recurrence — not just whether they closed on time.
Typically run by QA Manager
Design and development file review for a medical device, covering planning, inputs, outputs, verification, validation and transfer.
Typically run by Regulatory Affairs / QA
Receiving, status segregation, storage conditions and dispatch controls in a pharmaceutical warehouse.
Typically run by QA Officer / Warehouse Manager
Cold storage, qualified shipping configurations, logger review and excursion handling for temperature-sensitive product.
Typically run by QA / Distribution Manager
Observed dispensing operation covering line clearance, balance verification, second-person checks and cross-contamination controls.
Typically run by QA Officer
Sampling, trending, sanitisation and instrumentation controls on the pharmaceutical water system.
Typically run by QA / Utilities Engineer
Verifies classified areas remain qualified — requalification dates, particle counts, filter integrity, pressure cascades and viable monitoring.
Typically run by Validation / Engineering QA
Line clearance, coding verification, in-line rejection challenges and printed material reconciliation on a running packaging line.
Typically run by QA Officer / Packaging Supervisor
Reviews out-of-specification and out-of-trend investigations for assignable cause, retest discipline and complete data reporting.
Typically run by QC Manager / QA
Ongoing stability protocol coverage, chamber control and excursion handling, and how stability failures reach the market impact assessment.
Typically run by QC / Stability Coordinator
On-site qualification audit of a contract manufacturer or contract testing site against the quality agreement and GMP expectations.
Typically run by QA Auditor
Reviews whether changes are assessed, approved and validated before implementation — and whether temporary changes ever close.
Typically run by QA Manager
System-by-system audit of a GxP computerised system against 21 CFR Part 11 — validation, copies, retention, access, audit trails, operational, authority and device checks, personnel, documentation, open systems and every electronic-signature control.
Typically run by Computer System Validation Lead / QA Auditor
Paragraph-level audit of the electronic-signature and credential controls in 21 CFR Part 11 — the accountability policy, FDA certification, signing within sessions, biometrics, and the password and token controls of 11.300(b)–(e).
Typically run by Computer System Validation Lead / QA Auditor
Self-inspection of the pharmaceutical quality system elements inspectors test beyond the core: product quality review, ICH Q9(R1) risk management, batch certification, the Annex 1 contamination control strategy, Annex 11 and 15, materials, OOS/OOT, distribution and India's Revised Schedule M.
Typically run by QA Head / GMP Self-Inspection Team
Each of these has a real control library in the product — questions map to specific clauses, so gap analysis shows you what is genuinely unevidenced.
Baseline manufacturing quality requirements for medicinal and related products.
32 controls mapped
Quality management for medical device design and manufacture.
54 controls mapped
The world's most widely adopted quality management system standard.
44 controls mapped
Environmental management system covering aspects, impacts and compliance obligations.
33 controls mapped
FDA requirements for electronic records and signatures in regulated environments.
25 controls mapped
Not hypotheticals. These are the findings that recur in pharmaceuticals & life sciences, and every one of them is a question in at least one of the 19 templates above.
Templates, findings and AI prompts use your sector's terms, not generic audit language.
Pick one of the 19 templates above, walk the site with your phone, and see the finished report before you get back to your desk.