Mankind has a structured Quality Management System (QMS) based on Quality by Design (QbD) approach, as per the guidelines of cGxP.
The QbD approach enables product development and control based on scientific research and quality risk management. With our aim of excellence in delivery, QbD provides the highest quality products to patients and consumers. Through QbD, Mankind has also strengthened the practice of sharing and collaboration across the organization involving R&D, CQA, RA and Operations.
Quality Managements System is dedicated to development of process, manufacturing and distribution of products to guarantee safety, efficacy and compliance of customer and government regulations. It comprises of resource management, employee training, quality and compliance data trending and Annual Product Quality Review (APQR) through well-equipped Quality Control laboratories at the sites. QMS defines Mankind’s quality responsibility to ensure the achievement of adopted quality standards.
Total Quality Management is committed to customer satisfaction through an integrated system of tools, techniques, and training. It involves continual improvement of organizational processes resulting in high quality products and services.
Corporate Quality Assurance team regularly updates sites as per the requirement for continual improvement. It reviews the effectiveness of site quality and contract manufacturing sites according to cGxP compliance. Reviews are carried out for failure, rejection, market complaints, incidents, non-compliance, product stability and various CAPA which are then appropriately implemented.
Corporate Quality Assurance provides the necessary resources, technical guidance and training to ensure quality operation. It regularly upgrades skills and competence levels in various functions by introducing advance systems and technology. The Corporate Quality Assurance team regularly conducts audit of all manufacturing sites.
Our Key Quality system includes:
- Production system
- Facilities and equipment system
- Laboratory control system
- Materials system
- Packing and labelling
- Distribution system
Quality control and systems include advanced facility, sophisticated instrument and elaborate microbiology laboratory. Products are tested against the predefined stringent product specification set.
Good Distribution Practices is the Key to delivering products to the patients and consumers. Finished goods storage facilities have adequate controls as per product storage requirement and security. Goods are distributed through customized transport vehicles enabled with GPS electronic tracking system.