Stay in control in a fast-changing regulatory environment
Smart Assessments for GxP Audits
Objective
Regulated companies are subject to strict regulations to ensure customer safety and necessary product quality. Depending on the supply, all regulated companies are more or less regularly the target of inspections by authorities. GxP is a general abbreviation for the "good practice" quality guidelines and regulations.
For example, GMP regulations describe the requirements for manufacturing, while GLP describes the requirements for quality laboratories.
Examples
Source of Requirements
- FDA
- MHRA
- GAMP
- PIC/S/S
- EMA
- Company regulations
- Country regulations
Inventory Items
In Scope are Quality Management System Objects
- Process Validation
- Training Management
- Computer System Validation
- Laboratory Equipment Qualification
- Warehouse Management
- Product Registration
- Complaint Management
- Adverse Event Management