Name: GDP/GMP Documentation
Brand: Seemoto

Question 1

What is the difference between this GDP/GMP Documentation service and the GxP Validation offering?

Accepted Answer

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.

Question 2

Do the OQ acceptance criteria need to match the GDP-required storage temperature ranges exactly?

Accepted Answer

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.

Question 3

Can you qualify a monitoring system that is already installed and in use?

Accepted Answer

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.

GDP 文件入厂检查、现场检查及性能确认服务（GDP）

GDP 资质文件套装

包含的功能与可选功能

包含

可选附加组件

相关 IQ、OQ 和 PQ 服务（GDP）

GxP 验证

FDA 21 CFR 第11部分评估

常见问题

制定GDP生产GDP（GDP）/国内总产值（GDP）文件

GDP 文件 入厂检查、现场检查及性能确认服务（GDP）