41 ....................................................................................................................................................................................................................................................................................................................................................................................................................................................................... Quality and Product Responsibility We have established quality systems as per the regulatory requirements for every phase of drug development, manufacture and supply. The Quality System meets the global quality standards (US/EU/ Japan) for various stages of drug development and final API. We also update the quality systems as per the current regulatory requirement which is validated in the customer audits that were completed in the reporting period. We have proactively implemented digitalization as it supports our customers to assess our commitment to data integrity and product responsibility. Product-specific review by customers is a consistent practice to feedforward into setting the right quality goals and objectives. Our governance framework encompasses our facilities, people, procedures, and our value system that emphasizes integrity and continuous improvement with the functional and senior leaders periodically reviewing the compliance. Customer Audit Unit II 12 audits Unit IV Unit III No critical observations 4 audits No critical observations 30 audits No critical observations
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