At RRL, quality is a priority and emphasizes continuous improvement, meeting customer expectations, and maintaining regulatory compliance at all times. We set and follow the most stringent operating procedures, drafted by a highly technically competent team, adhering to the highest standards of safety practices.

 

Our quality team works relentlessly to constantly upgrade our manufacturing facilities. This is in addition to the technological innovations that are welcomed and adopted to produce and export high-quality medicines.


The Quality Centre also carries out internal audits of all manufacturing plants to check compliance with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP). By doing this, our quality team ensures that every product produced in our facility meets world-class standards.

The Quality & Regulatory Affairs group at RRL includes:


The Quality Control team provides service to R&D, Commercial, and Engineering; it also supports the API division of Royal International in India. The Quality Control team performs the stability testing of the commercial products for RRL and provides overseas support to Royal International Inc.


Quality Assurance at RRL mainly works to establish, monitor, and record “Quality” for all aspects of Current Good Laboratory, Manufacturing, & Clinical Practices. The key responsibilities of the quality assurance team are to detect deviations, correct errors, and improve efficiency. This team is also involved in establishing quality standards, developing processes, and ensuring compliance through risk assessments and implementing corrective and preventive actions throughout the organization.


Regulatory Affairs is responsible for the management of regulatory activities pertaining to products under development (New Product Development), as well as those currently registered and marketed (Product Life-cycle Management). Additionally, this team also supports Royal International Inc. for the Rest of the World (ROW) dossier submissions and Product Life-cycle Management activities.


The Computer Systems / Software Validation & Compliance (CSVC) team ensures all our systems and software comply with 21-CFR Part 11 and works to achieve continuous improvement under our high technology environment. We strive to make ourselves green by minimizing the use of paper through the implementation of various automated technologies in R&D, Production, Clinical facilities, and other support functions.