Quality Management System
Overlook is an ISO 9001:2015 certified company. Every aspect of our operations is governed by seven main quality principles as outlined in the ISO standard. These principles are the strategic basis for all decisions relating to Quality Management in our organization and are infused within all aspects of the language of our QMS:
Overlook product claims are based on extensive third-party validation testing by our FDA and EMA certified laboratory partners. We can provide the following documentation to support our products:
• Sterility Validation Package: Guaranteed Sterility Assurance Level (SAL) 10-6 utilizing simulated product approach. Includes sterility, real-time and accelerated aging, bag seal integrity and 30-month shelf life certifications. Quarterly dose audits are performed.
• Raw Material Certs: All plastics used in our products meet USP Class VI requirements, unless otherwise specified. Batch-specific raw material certs are maintained by quality.
• Gamma Cert of Process: Provided by our sterilization partners, per batch release. Sterilized batches are irradiated to a range of 25-40 kGys.
• Particulate Cleanliness: Overlook’s OneShot™ single-use filler needle cleaning process is validated to meet the small volume injectable requirements per USP <788>.
• Endotoxin Testing (additional fees apply): USP <85> test, per batch release.
Request More Information
Please use this form to request information related to our QMS. Our quality team will get in touch with you as soon as possible.