GDP/GMP Documentation
IQ, OQ & PQ Services (GMP/GDP)
GDP and GMP documentation suites covering system-level qualification: IQ (installation per specs), OQ (operation within parameters), and PQ (performance under real conditions). Includes execution records, validation reports, and SOPs.
GDP/GMP Qualification Documentation Suite
Wholesale distributors and GMP manufacturers must demonstrate that monitoring equipment is correctly installed, operates within qualified parameters, and performs under actual storage and distribution conditions — each as a separately documented and signed-off activity. Gaps between IQ, OQ, and PQ records are a common GDP inspection finding, leading to costly remediation and potential product holds. Seemoto's documentation suite ensures each qualification phase has complete execution records.
How it's deployed
The IQ phase captures installation evidence: hardware serial numbers, firmware versions, calibration certificates, and network topology diagrams confirming installation matches the approved design specification. OQ is executed with controlled temperature challenges to verify alarm triggering, data logging accuracy, and system response times. PQ collects continuous operational data over an agreed monitoring period in the actual storage environment.
Evidence & Reporting
Each phase produces a standalone execution report containing the protocol, test data tables, pass/fail results against acceptance criteria, any deviations with disposition, and a phase conclusion signed by the executing engineer and your site QA representative. The complete suite — IQ report, OQ report, PQ report, and operational SOPs — forms the qualification dossier referenced during GDP Guidelines (2013/C 68/01) and EU GMP Annex 15 inspections.
Included and Optional Capabilities
Included
- Validation Master Plan
Complete validation planning documentation
- IQ/OQ/PQ Protocols & Reports
Full protocol and report packages
- Risk Assessments
Comprehensive risk analysis
Optional add-ons
- On-site Audit Support
Expert support during audits
- Annual Revalidation
Yearly revalidation services
Related IQ, OQ & PQ Services (GMP/GDP) Offerings
Frequently Asked Questions
The GDP/GMP Documentation suite focuses on executing and recording the three qualification phases (IQ/OQ/PQ) with phase-specific protocols and signed reports, plus the SOPs needed for ongoing operation. The GxP Validation offering adds the overarching Validation Master Plan, formal risk assessments, and a consolidated Validation Summary Report — the additional governance layer typically required for higher-risk GxP environments.
OQ acceptance criteria are defined during the protocol authoring stage and are aligned with both GDP requirements (typically +2°C to +8°C for cold chain or +15°C to +25°C for ambient) and your internal product storage specifications. Seemoto works with your QA team to set criteria that are scientifically justified and defensible during inspection.
Yes — retrospective qualification is possible if sufficient installation evidence exists (calibration records, configuration backups, installation photographs) to support IQ documentation. Where records are incomplete, a gap assessment determines what additional evidence needs to be gathered before OQ and PQ execution can proceed in the normal prospective manner.
Plan GDP/GMP Documentation
Talk with Seemoto about the sensor, gateway, reporting, and compliance setup for gdp/gmp documentation.