What is Contract QA?
Today•4 min read
Contract Quality Assurance provides outsourced pharmaceutical QA support. Learn how it works and if it could benefit your business.
Many pharmaceutical wholesalers and distributors don't have the resources for a full-time Quality Assurance team. Contract QA provides expert support on a flexible, as-needed basis.
What Does Contract QA Cover?
•Quality Management System (QMS) development
•GDP/GMP compliance audits
•Regulatory submissions support
•Supplier qualification
•Deviation and CAPA management
•Documentation review
•Training programme development
•Pre-inspection preparation
Benefits of Contract QA
- ✓Cost-effective - Pay for what you need, when you need it
- ✓Expertise - Access experienced QA professionals
- ✓Flexibility - Scale up or down based on demand
- ✓Independence - Fresh perspective on compliance issues
- ✓Peace of mind - Expert support for MHRA inspections
When is Contract QA Useful?
Start-ups - Building QMS from scratch
Growing businesses - Need extra support during expansion
Small teams - No dedicated QA resource
Project-based - Specific regulatory submissions or audits
Inspection preparation - Need expert review before MHRA visit
What to Look for in a Contract QA Provider
- ✓Proven pharmaceutical industry experience
- ✓Understanding of UK/EU regulations
- ✓MHRA inspection experience
- ✓Flexible engagement models
- ✓Strong references or testimonials
How I Can Help
As an experienced GDP consultant and Lead Auditor, I provide Contract QA services including:
- GDP compliance audits and gap analysis
- QMS development and implementation
- WDA(H) application support
- Responsible Person services
- GDP training for your team
- Pre-inspection preparation