In the manufacturing of pharmaceuticals and food supplements—under GMP and FSSC 22000 regulations respectively—traceability is much more than a legal requirement: it is the tool that guarantees every stage of the production process is controlled and documented in accordance with the certifications held by Sincrofarm.
What is traceability, and why is it so important?
Traceability is the process that allows the entire journey of a product to be reconstructed—from manufacturing to dispatch—by precisely identifying:
- Which materials, quantities, and batches were used in each process.
- This is essential for pinpointing the origin of any issue and, if necessary, executing an effective and controlled market withdrawal, as required by GMP and FSSC standards.
Its importance lies in:
- Protecting consumer health by ensuring that products meet all quality requirements.
- Guaranteeing regulatory compliance with health authorities.
- Enabling the swift withdrawal of products in the event of incidents or alerts.
The role of quality assurance: oversight and precision
The Quality Assurance department, through detailed documentation and digital oversight, is responsible for ensuring that traceability forms the backbone of Sincrofarm’s quality system.
How is this achieved?
- Assigning every material and raw ingredient an internal code upon entry into the system, linking it to the supplier’s batch number.
- Reviewing the product structures in the ERP system and their corresponding manufacturing instructions to confirm that materials, batches, and quantities are correctly defined—both before starting and after completing production—ensuring full digital and documentary traceability.
- Conducting annual traceability exercises and mock recall drills to verify the system’s effectiveness.
- Using traceability as a key tool in the management of incidents and customer and/or supplier complaints.
Conclusion
At Sincrofarm, traceability is one of the most critical pillars of our quality system. It enables us to guarantee the highest level of safety for every product we manufacture—complying with the standards defined by our certifications and, above all, with the trust our clients place in us.