ProMed Pharma’s Quality Assurance is dedicated to delivering combination components of the highest quality that can be used in implantable products. To ensure components consistently meet quality standards and comply with federal regulations, a specific quality system was developed.
Drug eluting components are manufactured in an FDA registered facility with an excellent inspection history of NO FDA 483 findings
The quality system is compliant to:
Drug regulations 21CFR parts 210 and 211 (cGMP)
Medical device regulations 21 CFR parts 820 (QSR)
The quality system is certified to: ISO 13485-2003
Quality at ProMed Pharma is an integral part of our manufacturing process and company culture, as is evident through our Quality Policy:
ProMed Pharma, LLC. is committed to manufacturing quality products and serving the needs of our customers. We strive to provide products and services that meet requirements, are delivered on time, and priced to provide superior value. This fundamental practice ensures products consistently meet both customer and ProMed quality standards. All products are manufactured according to our Quality System which is reviewed and supported by Management.
Prior to release of the combination components, Quality ensures all drug content, purity, efficacy, strength and, dimensional requirements are met.
Drug-eluting components are manufactured in an FDA-registered facility with an excellent inspectional history of no FDA 483 findings. ProMed Pharma’s commitment to quality and compliance provides customers with quality parts that meet or exceed current industry standards.
Read More on Challenges of Manufacturing Combination Components.