43 • Quality systems for change control, customer complaints, nonconforming product control, recall, and a system to inform the customer of significant changes are robust • The facility is well-equipped, well maintained with cross-contamination controls and a plan to remain updated about cGMP requirements • Personnel are competent to manage site operations, knowing procedures, equipment, and protocols within their area of responsibility, and comply with cGMP requirements • Actions towards paperless operations, including GMP-Pro is encouraging We have a well-established procedure based on the various regulatory guidance to address customer complaints. The handling of a complaint is a time-bound process that involves acknowledging the complaint, investigation followed by implementation of CAPA where required, and finally, the closure of complaint addressing the customer’s concern. Facility (April-2019 to Mar-2020) No of customer complaints Status Unit-II 0 N/A Unit-III 0 N/A Unit-IV 5 Closed (no failure in the quality attribute of the product) Customer observations positively reinforce our approach to quality management Customer Complaints
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