Quality

At Inova Pharmaplastics, we are committed to always delivering the greatest value to our customers.

Our system is aligned with GMP guidelines and international regulatory frameworks.

MAINTENANCE OF THE VALIDATED STATE.

WE OPERATE UNDER STANDARDS SUCH AS:

· ISO 15378 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practices (GMP). Specific requirements for the applications of the ISO 9001:2015 standard. With reference to Good Manufacturing Practices (GMP)

· NOM-059 Good Manufacturing Practices for Medicines.

· NOM 241 Good manufacturing practices for medical devices.

· 21 CFR 820 is a set of FDA regulations that outlines the current good manufacturing practice (CGMP) requirements that medical device manufacturers in the United States must follow with respect to their quality system.

· ISO 12485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes.

· ISO 9000

CONTROL AND TRACEABILITY SYSTEMS

We operate under documented processes that allow us to:

✔ Batch traceability
✔ Statistical Process Control (SPC)
✔ Document management
✔ Internal validations
✔ Periodic audits

HIGH-PRECISION INFRASTRUCTURE

✔ 100% electric machines
✔ Robotic systems
✔ Contactless measurement
✔ SAP S/4HANA integration
✔ 99.99% HEPA filtration

Quality is built into every stage of the process | Quality is built into every stage of the process |