BCGVL has an established Quality Assurance Department. The Quality Assurance is a concept that takes care of all the matters, which shall individually or collectively influence the quality of the product. It is the responsibility of manufacturer to provide the end user with quality and safe vaccine. To achieve the quality objective and to build the quality at every stage of production, there shall be a system of Quality Assurance. The Quality Assurance is the responsibility of all the staff from the top management to lower most worker. In BCGVL, Quality Assurance department involve in bringing up of quality system and incorporating the procedures of GMP, GLP in the manufacturing and testing of our product at every stage.
As part of Quality system, our QAD has made the Quality policy and manual of BCGVL. The master document such as Site Master File, Master Formula Record, Master Validation Plan and Common Technical Documents were made by the Quality Assurance. It also involves in preparation, revision, reviewing, distribution, controlling and archiving of Protocols and SOPs used in our facility.
QA undertakes IPQA of all departments which include Production, Containerization, Quality Control and Maintenance departments. The planning and execution of annual calibration and validation programme were undertaken by QAD. QA also involves in undertaking vendor qualification and ensures the availability of raw materials required for production as per specification.
QA plays a vital role in the Quality audits of NRA/ SLA and initiate necessary action to comply with requirement of licensing authority. As a Quality objective, it undertakesthe change control, deviation management, investigation and CAPA in the facility. QA provides necessary instructions during the production and daily process. It alsoorganize the training activities for the staff. QAD involves and assistssupply of vaccine to UIP as per the supply order issued.
Inspection of BCG Vaccine Lots :
|S.No.||Particulars||No. of Occasions|
|1||Sample Draw||08 occasions|
|2||Cold Room Inspection||06 occasions|
One day visit of PG Medical students from Kings Institute of Preventive Medicine
|S.No.||Date||Medical College Name||No.of Students attended|
|1||17.09.2021||Thanjavur Medical College||02|
|2||18.11.2021||Chengelpet Medical College and Melmaruvathur Adhiparasakthi Institute of Medical Sciences||04|
|3||02.03.2022||Mohana Kumara mangalam Medical College, Salem||04|