Template Information
Self inspection checklist for eu gross distribution practice (gdp) compliance
Category: manufacturing
Template Questions
- Quality manual or equivalent documentation approach established
- Organisational structure of the distributor is defined in an organisational chart. The responsibility, role and interrelationships of all personnel is clearly indicated
- Outsourcing activities
- Layout of premises:
- Hygiene
- Temperature and Environment Control
- Equipment
- Computer Systems
- Documents are retained for a period stated in national legislation but at least 5 years at a separate, secure location
- SOPs
- Records
- Records include the following information:
- All medicinal products distributed in the have a marketing authorisation granted by the EU or by a Member State
- Supplier Qualification
- Qualification and approval of new suppliers: A risk based approach is used considering
- Qualification of Customers
- Qualification of customers and periodic re-checks include:
- Receipt of Goods
- Storage
- Segregation of Goods
- Destruction of obsolete Goods
- Picking and packing
- The rules for wholesale distribution apply in their entirety in the case of export of medicinal produ
- Export (exceptions)
- Complaints
- Returned Medicinal Products
- Medicinal products which have left the premises of the distributor are only returned to saleable stoc
- Suspected falsified Medicinal Products
- Medicinal Product Recalls
- Vehicles and equipment
- Delivery
- Transportation hubs
- Deviations
- Container and packaging is selected based on:
- Containers, packaging and labelling
- A document is enclosed to ascertain the following:
- Transportation of Products requiring special Conditions
- Final observations recommendations
- Sign off