The biologicals will accuse of the use of antibiotic severely when being produced

The biologicals will accuse of the use of antibiotic severely when being produced
It is reported (reporter Wang LeMin) In order to ensure biologicals quality safety, national food medicines supervise the administration bureau issuing the notice recently, demand to control the use of antibiotic and preservative in the production process of the biologicals strictly. The notice requires, should avoid using antibiotic as much as possible, forbid using penicillin or other - inner amide antibiotic, can't use antibiotic as preservative, inject it by can't add any preservative while freezing and doing preparationsing, intravenous parenteral solution can't add any preservative.
The notice requires, when the biologicals must use antibiotic to produce, should be chosen relatively lower antibiotic variety of the security risk, and the follow-up purified craft of the products should guarantee that can remove antibiotic in the products effectively, if the subsequent craft can't be removed effectively, can't add; Only allow to use antibiotic in viral vaccine production while cell preparing, cells proliferate; While using antibiotic, the finished product should measure the remaining amount of antibiotic while assaying, and stipulate the limit of remaining amount. Meanwhile, use biologicals of antibiotic must revise and enlarge the relevant content in the medicines manual, and mark out the person who has allergic history on this antibiotic can't be used.
The use for preservative of notice is limited strictly too: Should avoid, add preservative, including mercury preservative in middle product and finished product as much as possible; Parenteral solution of single dosage should avoid adding preservatives as much as possible; As to the intersection of many people and pieces of preparation, and longest duration that give a recommendation judge whether to use preservatives uncap, according to pollution that may take place use; If need to use, should prove preservatives will not influence security and effectiveness of vaccine; Include the products of preservative in the finished product, its preservative should adopt the minimum adding amount in restraining fungus range effectively, and should presume limit is controlled.
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