Good Distribution Practice (GDP) is a set of principles ensuring that the quality and integrity of medicinal products are maintained throughout their journey from the manufacturer to the pharmacy. It guarantees that the product comes from a legal source of supply.
The legal basis requiring the implementation of the GDP system is the regulation of the Minister of Health dated March 13, 2015, on the requirements of Good Distribution Practice, and the regulation of the Minister of Health dated June 17, 2016, amending the regulation on the requirements of Good Distribution Practice.
A quality system based on GDP principles in a company should ensure:
- Ordering, delivery, receipt, storage, dispensing, or shipment of medicinal products in accordance with the requirements of Good Distribution Practice (GDP).
- Clear definition of the scope of responsibilities and authorities of the management.
- Timely delivery of medicinal products to authorized recipients.
- Ongoing documentation of activities.
- Documentation and investigation of deviations from established procedures.
- Implementation of corrective and preventive actions to eliminate and prevent deviations in accordance with quality risk management procedures.
Certification of the GDP system brings numerous benefits, impacting both the internal functioning of the company and enhancing its prestige and trustworthiness in the eyes of potential clients.
Our clients confirm that GDP certification increases competitive advantage and reduces the risk in the distribution chain of medicinal products.
GDP certification is the highest testimony that your company adheres to Good Distribution Practice in accordance with legal requirements.
How does the certification process with GLOBAL QUALITY unfold?
- Contact Us
Your first step is to reach out to us. Please use the inquiry form available on our website. If needed, we’ll respond to any questions and address potential concerns.
- Proposal and Collaboration.
After understanding your needs, we present a personalized offer along with general terms of collaboration. Once you accept our proposal, we ask for the signed agreement.
- Audits.
A pivotal moment in the certification process is the certification audit. One of our auditors visits your company at a scheduled time and assesses the criteria necessary for certification. If you deem it appropriate, a diagnostic audit can be conducted before the certification audit to ensure that all required standards are correctly implemented and functioning.
- Audit Report.
The auditor generates a report based on the assessment conducted in your company. If not all required criteria are met, we will inform you and specify a timeframe for corrective actions.
- Decision on Certification.
After preparing the report, the auditor submits it to our unit for final verification. If the report is accepted, we make a decision to issue the certificate.
At every stage of the certification process, you can count on our support. We are here to assist our clients in the development of their business.