Define a risk-based audit scope
Sites, processes, products, partners and previous deviations determine objectives and sampling.
- GDP criteria
- Document and data request
- Interview and sample plan
- Independence and confidentiality
Service area · Wholesale distribution of medicinal products
Run a GDP audit and prepare systematically for inspections
tiger.PHARMA audits GDP processes, documents risk-based findings and supports CAPA, mock audits and inspection readiness for wholesale, storage and transport.
Plan a GDP audit →GDP audit · mock audit · CAPA · inspection readiness
GDP audit & inspection readiness
tiger.PHARMA audits GDP processes, documents risk-based findings and supports CAPA, mock audits and inspection readiness for wholesale, storage and transport.
An effective GDP audit connects regulatory requirements with the process actually performed and evaluates documents, data, decisions, roles, records and effectiveness.
tiger.PHARMA Kompetenz
Topics we master
Conduct the mock audit
The audit follows the process from receipt to delivery and tests whether evidence can be reproduced.
- Responsible Person and roles
- Storage, transport and temperature
- Returns, recall and deviations
- Data integrity and service providers
Close findings through effective CAPA
Findings are prioritised by risk and linked to root cause, action, owner and effectiveness review.
- Risk-rated report
- Root cause and CAPA plan
- Deadlines and evidence
- Follow-up and effectiveness check
FAQ
Frequently asked questions
Does a mock audit guarantee a successful inspection?
No. It can reveal gaps and improvement needs, but it cannot replace an authority decision or consistently maintained GDP processes.