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Quality & Regulatory

Quality & Regulatory

At ARPL quality is a priority & lays emphasis on continuous improvement, meeting customer expectations and all time regulatory compliance. We set and follow the most stringent operating procedures drafted by a highly technically competent team, adhering to 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.

Quality & Regulatory Affairs group at ARPL includes:

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

Quality Assurance at ARPL 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, to correct errors and to improve efficiency. This team is also involved in establishing quality standards, developing processes and ensures compliance by means of risk assessments and by implementing the 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 Apotex Inc., for the Rest of the World (ROW) dossier submissions and Product Life- cycle Management activities.

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