P Compliance Certificate for the transport company confirms that the company meets the highest requirements of the Good Distribution Practice – it gives the opportunity to provide services to the pharmaceutical industry and the logistics of clinical trials.
GDP Compliance Certificate is issued by the Centrum DPD limited liability company with registered office in Warsaw after GDP certification audit conducted by Centrum GDP auditors – aim of the audit is to confirm that the pharmaceutical warehouse meets all the requirements of GDP including GDP regulation issued by the Polish Minister of Health, Polish Pharmaceutical Law and guidelines of the competent European authorities, such as Directive 2011/62/ EU and GDP guidelines concerning medicinal products for human use 2013 /C 68/01.
The checklist of the GDP certification audit includes checking whether the company has implemented:
- Validation Policy
- Validation Master Plan and the validation schedule
- Documentation of risk analysis and risk management
- Training GDP certificates for personnel and drivers
- The procedure in scope of qualification of the process of transportation
- Procedure for document management
- Procedure for corrective and preventive actions
- Procedure and/or instructions concerning the rules for shipping, loading, transportation and unloading of products including the rules of procedure of maintaining the “cold chain” products
- Procedure for handling complaints and returns
- Procedure re proceeding in case of failure of cooling devices of vehicles
- Procedure for internal audits
- Procedure regarding insurance
- Procedure for transport safety
- Procedure for the qualification of personnel (drivers and supervisors)
- Procedure for qualitative qualification service providers
- The training program and code of conduct for drivers
- Procedure for qualification of transport vehicles including:
- Mapping crates of cargo vehicles,
- Control of operational and technical documentation provided for vehicles – all documents must be complete and current.
- The qualification of measurement devices used during transportation – devices must have valid documents (certificates of calibration, calibration) confirming the proper operation of their vehicles.
Certificate of GDP Compliance is issued for a period of three years, subject to the Centrum DPD two checking audits executed 12 and 24 months after the certification audit.
Re-issue of the GDP Compliance Certificate by Centrum DPD is only possible after a full recertification audit made by Centrum DPD auditors.