QA department is responsible for organizing professional training for all personnel of the company including QA and QC employees. There is a training program on current GMP, on job training, managerial training, and training is conducted in-house and external training for the key personnel in accordance with the personnel policy of the company. Every employee of the company has a training file which is well kept and maintained.
Together with relevant department of the enterprise, QA Department conducts the job of supplier’s Audit to evaluate quality system of the main materials suppliers. Within the company, the QA carries out site supervision and spot check on daily basis to key quality control points and carry out regular check on non- key points according to relevant SOPs.
QA undertakes surveillance work regularly to operation room, equipment, personnel; as well as to the technical water and gas. QA department is also in charge of assess of quality stability of the raw material, semi-finished product and finished product and responsible for collecting and summarize quality data.
QA is responsible for validation of workshop, facilities, equipments, clearing of the equipments and production process. QA organizes self-audit to ensure proper improvement action will be taken in compliance with GMP standard.
QA is in charge of monitoring and evaluation in the procedure of production. QA decides the usage of materials and semi-finished product, examines the batch records of the finished products before releasing, decides the release of finished products, and examines and verifies handler of the defective goods. QA exercises quality veto power to guarantee the principle of “materials and semi products are not released for use or product are not released for sale until their quality has been judged satisfactory in quality control laboratory."