Follow
a. Quality Assurance Department ensures the quality of all batches produced at every stage of manufacturing/processing of drug products.
b. This is achieved by performing monitoring functions in accordance with the prescribed QA system for the following areas:
=>> Warehousing of incoming material, containers and closures, labels etc.
=>> Manufacturing processes and process checks
=>> Process monitoring and process control
=>> Review production records
=>> Final release or rejection of each batch of drug product for distribution and sale
=>> Stability testing and product shelf-life evaluation
=>> Warehousing of Finished Products (Pharmaceutical Products)
=>> Complaints and product recalls
=>> Managing change control systems
=>> Specifications are beyond investigation
=>> Deviation investigation
=>> Returned Goods (Collection and Disposal)
=>> Internal quality audit and quality review
=>> Control of non-conforming products
=>> Reprocessing of non-conforming products
c. To achieve the objectives of quality assurance, the functions of the department can be classified as follows:
=>> To plan and conduct all quality assurance activities to ensure the quality of all products produced by the company.
=>> Coordinating with the production department to control their processes and products at every stage of production to meet established specifications through tests, audits and reports.
=>> Coordinate development of analytical methods in coordination with quality control and research and development.
=>> Review adequacy and relevance of specifications and analytical methods in coordination with quality control and R&D.
=>> Coordinate quality control laboratory technical audits to ensure analytical quality systems are providing the highest quality data and analytical instruments are functioning properly and are on calibration and service schedules.
=>> The Quality Assurance and QA Department shall be responsible for the records and release functions which shall include:
=> Maintenance of quality control records of manufacturing procedures for each batch produced.
=> Records of release, quarantine or rejection of ingredients and finished products, containers, closures and labels based on quality control test results.
=> Routine “Good Manufacturing Practice Auditing” of manufacturing processes, controls and related areas.
d. Advise and organize training programs to develop technical and administrative skills of all employees to meet cGMP regulations on a continuous basis, in coordination with Plant and Quality Head.
e. cGMP and Good Laboratory Practice – Establishing guidelines and procedures on standard operating procedures for overall quality control and assurance activities. Protocols related to procedures/procedures/purification/validation of analytical methods etc.
f. Change Control Committee/Technical Committee to conduct overall review, failure investigation, quality trend analysis, market complaint investigation, batch failure investigation, deviation, change control procedure verification, specification updating, test procedure, supporting process for production etc.
g. Liaising with regulatory authorities for renewal of new product manufacturing licenses and the same and other regulatory requirements.
h. Following reporting system to Corporate Quality Head on daily/weekly/monthly basis as per standard procedure.
