We are proud to announce that our production plant in Castellar del Vallès (Barcelona) has successfully passed the GMP (Good Manufacturing Practices) audit conducted by Rephine, a highly respected organization known for its expertise in pharmaceutical industry audits.
The scope of the audit included the manufacturing of pharmaceutical excipients, confirming that our processes meet the highest quality standards required by the industry. This validates the strength of our system and our strong commitment to operational excellence.
The audit was carried out in accordance with the standards and methodologies established within Rephine’s quality system, based on ISO 9001 and ISO 17020 standards.
The regulatory framework considered in the audit includes:
- EU Directive 2001/83/EC and its amendments (2004/27/EC and 2011/62/EU)
- FDA 21 CFR Parts 210 & 211 (USA)
- UK Human Medicines Regulations 2012 (SI 2012/1916)
As a key reference, the IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients was used. In this regard, we highlight that Panreac Química SLU is an official member of IPEC, which reinforces our commitment to industry best practices.
This certification strengthens our position as a trusted supplier to the pharmaceutical industry and demonstrates our ongoing commitment to quality, safety, and regulatory compliance in all our processes.
You can download the certificate here.
Thank you to our entire team for making this possible!