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1.Prepare and revise specification for R&D product and commercial product 2.Help QC to resolve OOS and other deviation 3.Prepare and review new drug application file 4.Prepare and revise method validation, cleaning validation and process validation the flat iron shop for us protocol and report 5.Help QA to review master batch record 6.Participate in supplier audit.Establish and strengthen software for six GMP systems from 2006 Update hardware system and perform validation from 2006. Adjust performance of HVAC system and perform validation for HVAC and 12hot cheap prom dresses filter system. Perform PQ for purified water system in accordance with USP. Perform temperature and humidity mapping validation for warehouse. Update and validate the hardware system of all lab equipments so as to meet the requirement of part 11,21CFR. Perform the transportation validation to make sure transportation from china to USA will not affect the quality of the product.Review DMF of sell discount wedding dresses factory and audit the API factory several times in 2006, 2007 and 2008 so as to make sure all system meet the requirement of cGMP. Participate in FDA’s inspection to this API factory in September of 2008 and help API factory to make response to FDA’s Form 483 and follow its blog lace wedding dresses. Produce acyclovir tablet in January of 2007and perform stability test, submit the ANDA market authorization application to FDA in December of 2007. Perform continuous cGMP training to all staff, including regulation of ICH, PIS/S, EU GMP and WHO GMP. Perform cleaning validation and process validation to all products which share equipments with acyclovir tablet Received cheap wedding gown dresses Pre-approval inspection by FDA from February 23 to February 26 of 2009 and passed the site inspection and get the EIR in May of 2009.
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