From November 20 – Nov 23, 2011, a GMP expert panel fromChina’s SFDA conducted an on-the –spot audit to thenewly-built workshop of ASK. And through the four-dayinspection, the team gave a final approval and concluded thatthe organization structure, premises and technologicalverification etc correspond with the requirement of newedition GMP, therefore, ASK has successfully another workshopin operation.
The inspection was made exactly as per the requirements of Newedition GMP, carried out respectively to the warehouse,water-making systems and center labs; to the production lineof generic drugs and package line in dynamic running; and alsoa meticulous examination was organized to the management anddossier systems of manufacturing management, quality control,equipments maintenance and management, verification,warehousing of materials as well as personnel training Having a new workshop is the decision by the management of thecompany to meet the requirement of marketing and salespressure for supplying. Well preparation for auditing andsmooth operation after that was made in five months, duringwhich varieties of work was undergone ranging fromorganization structure, detailed monthly duty planning,comprehensive hygiene and cleaning, equipment debugging,operating post determination and personnel training,examination of theory and actual operation, equipmentoperation, filing of batch production documents and variousverification etc. Each issue and problem found in the trialoperation was rectified and approved.