Commitment to Compliance and Continuous Improvement

Vikasith Lifesciences operates under a robust Quality Management System (QMS) that aligns with global regulatory standards. Our vendor management program ensures raw materials are sourced from approved suppliers, supported by documented vendor audits, on-site evaluations, and critical quality attribute control through specification testing.

We conduct regular training and internal audits, stability protocol reviews, and Annual Product Quality Reviews (APQRs) to ensure continuous compliance. The quality team manages customer complaints, coordinates client and regulatory audits, and provides Validation Qualification (VQ) support for key suppliers.

Execution activities include preparation and review of development reports (PTTD and ATTD), master batch records, and process validation protocols. The Critical Strategy Summary Report captures CPPs (Critical Process Parameters) and CQAs (Critical Quality Attributes) for each product.

During dispatch, our quality team oversees raw data review, COA approval, executed batch record verification, retained sample management, and label control to ensure full traceability and compliance.