The quality system is the most important element in order to guarantee the quality of our medicinal products.
Its implementation is a must for accomplishing the GDP regulations.
This will lead the company to minimized the implementation cost and time delay.
As part of the GDP quality system implementation, an audit to determinate the current company situation will be carried out and, depending on its results, the action plan and the project scope are stablished.
Every activity related to the GDP will be verified and a risk assessment will be break down into chapters such as:
- Quality Management (records, traceability, deviations, CAPAs, risk management, indicators, etc.)
- Staff involved (person responsible of the department/project, training system, hygiene, etc.)
- Facilities and equipment, if applicable (cleaning system, pest control, safety measures, temperature, humidity, mappings, equipment calibration and qualification, maintenance, etc.)
- Production / working station (traceability, risk of counterfeit, supplier’s qualification, audits and licenses, client’s qualification, reception, stockage and dispatch of products, EFO/FIFO systems, inventory, order processing, etc.)
- Complaint management, return policy, risk of counterfeit, drugs/products recovery, mock inspection
- Outsourced activities (evaluate outsourced activities, audits, contracts, etc.).
- Transportation (routes assessment, type of transportation, qualification of the transportation process, logistic distributors audits, etc.)
All these activities carried out as part of a unique project has quality and practical approach. It allows companies to implement in the best way possible the GDP quality system in good time and following the quality standards.