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formulations and implementing new revised GMP …
2012-11-04
Answer: basis "on implementing the quality control of pharmaceutical production specifications (2010 revision) > notification" (countries food also Ann [2011] no. 101) requirements, since on March 1, 2011, all new pharmaceutical producing enterprises, pharmaceutical production enterprise new (change, expansion) workshop shall be in accordance with the pharmaceutical production quality control criterions (2010 revision) "requirement.The existing pharmaceutical production enterprise blood products, vaccines, injection asepsis pharmaceutical producing, should be in 2013 to December 31 of pharmaceutical production quality control specifications (2010 revision) "requirement.Other classes of drug production shall in 2015 to December 31 of pharmaceutical production quality control specifications (2010 revision) "requirement.Have not reached the pharmaceutical production quality control criterions (2010 revision) "requirements of the enterprise (workshop), before the above stipulated time limit shall not continue after the production of drugs. According to the "on further clear eye ophthalmic preparation and other products implement the newly revised drug GMP deadline notice" (countries food also Ann [2012] no. 106) requirements, intraocular injection, intraocular insert agent for surgery, the wound, corneal penetrating injury with eye ophthalmic preparation and eye ophthalmic liquid preparation should be before December 31, 2013 to achieve the new revised drug GMP requirements, and the other eye ophthalmic preparation should be before December 31, 2015 to achieve the new revised drug GMP requirements.Other legal drug standard list of asepsis check project all preparation and drug shall, before December 31, 2013 to achieve the new revised drug GMP requirements.According to the drug administration of in vitro diagnostic reagent should before December 31, 2015 to achieve the new revised drug GMP requirements. |
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