Manufacturing
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Strength of Quality Management System
- ✱ Updated quality policy, objectives and quality manual are in place for practice.
- ✱ GMP and QMS practices throughout the product life cycle.
- ✱ Zero Defect Product.
- ✱ QA department is independent from production.
- ✱ QMS tools like quality risk assessment, change control, CAPA management, internal audit, GMP training, product complaint handling, product recall, annual product quality review, good documentation practice and data integrity are applied.
Quality Management System (QMS)
The Quality Management System of Klarris conforms to the requirements of the Directorate General of Drug Administration (DGDA), World Health Organization (WHO) and pharmacopoeial standards such as BP, USP and EP.
The QMS is overseen by the Head of Quality Assurance, with all departmental heads working collaboratively to follow and maintain quality standards.
Built-in quality is achieved through validated vendors, qualified personnel, validated processes, qualified equipment, HVAC systems, validated analytical test methods, complete batch document reviews, retention sample monitoring and strong distribution practices throughout the product lifecycle.