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The Quality Management System of Manufacturer:

Quality Assurance is responsible for ensuring that adequate arrangements are made to implement the Quality Policy through an elaborate set of Quality Management & Documentation System. It is responsible to design; implementation and review of Quality Management System to ensure that the medicinal products are manufactured using processes which incorporate cGMP principles and which consistently produce medicinal products meeting its specifications throughout the shelf life. Quality Assurance and Qualified Personnel (QP) will be responsible for Release of product for sale and distribution.

Quality Policy mainly aims in:

• Understand and Meet the Customers Expectations.
• Provide Quality Product to Satisfaction of Customer.
• Ensure Compliance of all Legal Requirements.
• Continually improve the Effectiveness of Quality Management System.
• Achieve Continued and gradual Improvement through Motivated and Trained Work Force.
• Manufacture Products of International Quality

The Quality System / Quality policy includes the:

• In-Process Control
• Implementation of Documentation System
• Directive and Controlling of cGMP Operations
• Provide guidance for compliance to various national and International cGMP requirements
• Approve Deviations or Changes in the System
• Total Quality Management of the Plant
• Control of Material Specifications (starting materials, in process materials, packaging materials and finished products)
• Monitoring and Control of the Manufacturing Environment
• Qualification and Validation Activities
• Employee Training and Personal Hygiene
• Approval and Monitoring of Suppliers of Materials
• Designation and Monitoring of storage conditions for Materials and Products
• Retention of Records
• Internal Inspection, Investigation and Collection of Samples
• Annual Product Quality Review
• Investigation of Non-Conformances and Market Complaints
• Vendor Development through External Audit and Compliance of the findings
• Approval of Manufacturing Documents
• Document Control
• Batch Release / Rejection (Based on test data and records)
• Handling of Investigations
• Handling of Failures and Deviations
• Out of Specifications / Out of Trends
• Process Validations
• Quality Risk Managements
• Management Review Report (For monitoring system maintenance)

Quality Assurance will monitor the conformance of the materials at all stages to the approved and authorized specifications, which are in line with either pharmacopoeial or internal quality standards.

It continuously will monitor and maintain the data related to testing, manufacturing, in process controls and any other monitoring of process, process conditions, services and utilities used in the manufacture of the medicinal products.

Information of activities for which the site will be accredited and certified, including dates and contents of accreditations, names of accrediting bodies.