To help reduce the risk of non-compliance to demanding regulations for medical devices and pharmaceutical packaging, we need to start at the beginning of the process: the materials used and what’s inside.
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 impact on patient safety. Since 2008, Clariant has been developing the approach of “Controlled, Consistent, Compliant” for our MEVOPUR and REMAFIN-EP products. 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, Clariant created three externally certified ISO13485 sites, offering dedicated production, global project support capability and the security of back-up supply. In addition, some specialist 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 Clariant’s medical color and performance masterbatches and compounds. During 2010 each of the 3 medical Centers of Competence gained external certification to ISO13485.
Our ‘open to audit’ policy and controlled operations help meet FDA and other regulatory guidelines regarding fully traceable production. We strive constantly 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 with annual internal and external audits. Since 2010 internal ISO13485 GMP in operation at a further two specialist sites in Europe.
- Documented design review and consultation process before we start development to ensure we fully understand your needs for the application and regulatory requirements.
- Production segregation or line clearance and validation to confirm effectiveness of cleaning.
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.
- Validated back-up facilities help maintain business continuity in case of emergency.
- Finger-printing and incoming routine batch testing of the raw materials used in MEVOPUR® and REMAFIN®-EP help detect changes and implement counter-measures.
Characterization of our raw materials and/or final masterbatches and compounds 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, further encouraging transparency between Clariant and our 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);pharmaceutical packaging and drug-contacting materials (biological evaluation USP<87><88>, EP chapter <3.1> and the new 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).
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