Quality

Quality Assurance & Quality Control

Quality Management Systems (QMS)

Independent Quality Assurance department is well in place having Robust QMS to ensure Product Quality at each stage of manufacturing

  • Driven through Quality Policy.
  • Site Master File.
  • Quality Manual.
  • Validation & Qualifications system.
  • Computerized System Validation.
  • Technological Process Validation.
  • Calibration Master Plan.
  • Vendor Management System.
  • Document Control Management system.
  • Review, approval and control of QC Test specification and procedures.
  • Batch creation, Bach manufacturing data review and Product batch Release.
  • Training Management system.
  • Change control Management system
  • Deviation Management system
  • Investigations & CAPA Management
  • Audit and Compliance.
  • Self -Inspection
  • In-Process Quality Assurance.
  • Analytical Lab (QC lab) Assurance.
  • Control Sample Management.
  • Quality Risk Management system.
  • Statistical evaluation of Quality attributes and system performance.
  • Product Quality Review system
  • Product complaints Management.
  • Recall & Returned goods Management.
  • Monitoring of Plant Preventive Maintenance
  • Environment Controls within and outside manufacturing plants

Quality Control

Independent Quality Control Unit is well established for confirming the Product Quality through –

  • Sampling, testing (chemical & Microbiological parameters) of Raw Material, Packaging Material, In-process and Finished Products as per standard specifications and compendia methods.
  • Approval and release of Raw Material, Packaging Material, In-process and Finished Products.
  • Stability studies of the product as per standard specifications and Guidelines.
  • Environmental Monitoring for Microbial Attributes.
  • Continuous Monitoring of Water system.
  • Reference and Working standard management.
  • Lab reagent Management
  • Analytical data management done through Validated Laboratory Information System software system.
  • Chromatographic instruments are connected with CFR Part 11 compliant Chromeleon and lab solution software to ensure Data Integrity Requirement.
  • Analytical Data Trending and Laboratory investigation of OOT and OOS results.

Quality Policy

  • Customers are at the centre stage of organisation. We shall continually develop and produce quality pharmaceuticals and healthcare products that shall satisfy the growing medical needs of a customer globally.
  • We shall implement current Good Manufacturing Practices in all our manufacturing and shall comply uncompromisingly with best practices for meeting with all regulatory requirements and expectations.
  • Our Quality Management System shell reflect higher standards of excellence in its design and implementation so as to give assurance with respect to Quality, Purity, Safety, Efficacy and Reliability of our products and services.
  • We shall pursue innovation, continuous improvement and advanced technology manifestation as a guiding force in our research and development.
  • Employees are our biggest asset. We hall ensue unequivocal practices to ensure training and development and so also occupation health and safety of all our employees.
  • We shall stand true to our global corporate citizenship as an observant and follower of legislation with respect to Environmental Protection. We shall protect the ethical values of our stakeholders and shall always adopt measures appropriate to the provision of Pharmaceuticals and healthcare.
  • We shall make available the requisite measures and resources to achieve the quality goal of the organization and to ensure stringent at airlines to this quality policy at all levels

Quality Policy

Quality Policy Final 2

Environment, Health & Safety Policy

Quality Policy Final 1