Materials and their impact on patient safety
Increased use of Quality by Design (QbD) processes means that more consideration needs to be given to materials used and their impact on patient safety. Avient has developed the approach of “Controlled, Consistent, Compliant” for our MEVOPUR™ and REMAFIN-EP™ products, designed specifically for healthcare applications. This encompasses the principles of change control management, good manufacturing practices (GMP) and the ISO13485 quality standard, as well as regulatory support service.
In 2010, we created three externally-certified ISO13485 sites, or Centers of Competence, which offer dedicated production, global project support capability, and the security of back-up supply. In addition, some specialized products are produced in internally-certified sites operating under the same ISO13485 Standard Operating Procedures (SOP).
To help customers manage their risk potential, dedicated facilities and systems govern the production of our medical colorants and performance masterbatches.
Our ‘open to audit’ policy and controlled operations help meet FDA and other regulatory guidelines regarding fully traceable production. We continually strive to improve our practices and reporting systems by working closely with partners in the supply chain.
• Common global Quality Management System (QMS) with external ISO13485 GMP certification of the 3 dedicated production units, and conducting annual internal and external audits. Internal ISO13485 GMP is in operation at two additional specialist sites in Europe.
• Documented design review and consultation before we begin development. This ensures we fully understand your needs for the application and the regulatory requirements.
• Production segregation or line clearance and validation to confirm effectiveness of cleaning.
We employ processes to ensure the same products are available from any production facility, meeting the same technical, regulatory and quality requirements.
• Change control agreements with up to three years’ notification.
• Harmonized product formulations available from all three Centers of Competence.
• Validated back-up facilities help maintain business continuity in case of emergency.
• Fingerprinting and routine batch testing of the raw materials used in MEVOPUR and REMAFIN-EP help detect changes and implement countermeasures.
Characterization of our raw materials and/or final masterbatches – through careful selection, pre-testing and evaluation – gives our customers a clear picture of their material of choice.
We are proud to develop material formulations that can help customers more easily comply with local regulatory requirements. Documentation supporting relevant product safety and compliance data is available to all customers.
• Declarations based on pre-testing of the ingredients we use to standards typically required for medical and diagnostic devices (biological evaluations ISO10993, USP <87>, <88> for class VI devices); and for pharmaceutical packaging and drug-contacting materials (biological evaluation USP<87><88>, EP chapter <3.1> and requirements USP<661.1> and ICHQ3D extractable metals).
• Letter of Authority (LoA) for our Drug Master File (DMF) and Device Master File (MAF).
• Disclosure of ingredients for purpose of regulatory filings (under specific confidentiality agreements).