Quality Assurance

Quality Assurance

The Quality Assurance department monitors and ensures implementation of Quality Policy and Quality management system in pharmaceutical operations

Quality Policy and Quality Manual

Blue Cross Quality Assurance System is guided by Quality Policy and Quality Manual. All pharmaceutical activities are organized and implemented according to the current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).

Continual Improvements

Blue Cross is committed to constantly improve the quality systems & quality standards of our product and services by implementation of risk based QbD approach, up-gradation in technology, compliance to cGMP in line with National and International Regulatory requirements and continuous training to meet Quality Standards.

Batch Release

Batch is released for distribution after systematic review of step wise test results and process documentation to ensure the Quality, Purity and Safety of products.

Standard Operating Procedures:

All procedures related to pharmaceutical activities and cGMP are written in the form of standard operating procedures (SOP’s), which acts as guidelines for the training of personnel and performing pharmaceutical activities.

Validation and Qualification

Validation and Qualification is used as a tool to provide a high degree of assurance that, facility, systems, equipment, processes and tests procedures are consistently produce products meeting its predetermined specifications and Quality attributes throughout its life cycle.

Investigation & Prevention:

All Quality complaints & deviations are investigated and risks based appropriate Corrective Preventive actions (CAPA) are taken to avoid recurrence.

Training Programs

Regular training program is conducted as per the annual training calendar and training needs identification. All employees are encouraged for regular up-gradation of their technical knowledge through regularly visiting identified websites, knowledge-sharing discussions and use of BCL library facilities.

Management of Vendors:

The Raw and Packaging material vendors are developed and approved as per the standard operating procedures. The raw and packaging materials are purchased from the approved vendors only. All approved vendors are assessed annually on the basis of Quality, Delivery and Cost.

Blue Cross, has a firm commitment of all our personnel involved in various pharmaceutical activities to assure “QUALITY” of our products, conforming to the laid down specifications and adherence to GMP regulations in all operations. The manufacturing & testing operations are carried out at appropriately controlled specified environmental conditions & under the supervision of competent technical staff.