Canvax is committed to support the entire scientific community and industrial customers worldwide, with products distinguished by its performance, accurate technical Information and easily-to-use.
Canvax operates in its first-class facilities under certified:
- ISO 9001:2015.
- ISO 13485:2016 for the Research use Raw Materials and Ancillary Reagents.
- cGMP, current Good Manufacturing Practice and in continuous improvement according to ICH Q7.
Manufacturing sites is QMS build following Eudralex vol. 4 and 21CFR 210/211 principles.
Our robust Quality Management System (QMS), includes different processes such us Risk Management, Change Control, Purchases and Suppliers Management, Stock Management, Maintenance, Document Management, Non Conformances Management and CAPAs, Clients Satisfaction and Complaints Management, Audits, Media and Solutions Preparation, Waste Management and Quality Management (Raw Material and Product Release Procedures).
In addition, Quality Agreements are stablished with Suppliers when deemed necessary due to the criticality in the process of the material supplied. There is a traceability of the raw materials and consumables from receiving until their use in manufacturing as per the guidelines described on the Stock Management SOP of the company.
Comprehensive Batch, Master Production and Testing Records are generated for the manufacturing activities at Canvax.
Also, Canvax has a Quality Assurance Department independent to the manufacturing and QC departments which oversees the QMS system and approves the product release.
Due out stringent quality controls, Canvax can provide all the documenting requirements as: batches disposition package and required information (QA) like all production batch records including solution prep records, a batch disposition checklist, all QC Test/Request Forms (result worksheets) and associated QC testing raw data, Critical EM excursions, label issuance and reconciliation records, raw material specifications, any planned or unplanned deviations associated with the Customer’s product, related OOS result investigations, Certificate of Analysis, etc.
To find out more about Canvax Quality Process related with cGMP and Customized solutions, please contact us.