“In general, this means any product (including one that contains cannabis or cannabis-derived compounds) marketed with a claim of therapeutic benefit, or with any other disease-related claim, is considered a drug,” FDA wrote in the guidance. “To be legally marketed in interstate...
? The technique described below assumes that membranes about 50 mm in diameter will be used. If filters of a different diameter are used, the volumes of the dilutions and the washings should be adjusted accordingly. The filtration apparatus and membrane are sterilized by appropriate means. The ...
(unlessotherwisejustifiedandauthorized)*每个培养基中的最小供试物品数量NumberofItemsintheBatch该批物品的数量(除非另有依据或授权)Antibioticsolids固体抗生物Pharmacybulkpackages(<5g)20containers药房散装(<5g)20个容器Pharmacybulkpackages(5g)6containers药房散装(5g)6个容器BulksandblendsSeeBulksolidproducts散装并...
Operational modifications are the primary means of compliance, but the pharmacy's HVAC system also must be evaluated. USP 797 offers some confusing requirements for HVAC system designers, but compliance in an existing facility is not as difficult as it may seem.Christopher P. Rousseau...
With this revision, it is now clear that compounding means combining 2 or more drugs to create a new drug that is not FDA approved.5 For further clarification, organizations like the American Society of Clinical Oncology and Community Oncology Alliance also offer online resources outlining ...
The technique described below assumes that membranes about 50mm in diameter will be used. If filters of a different diameter are used, the volumes of the dilutions and the washings should be adjusted accordingly. The filtration apparatus and membrane are sterilized by appropriate means. The ...
The contents of containers holding 10 mL or more may be determined by means of opening them and emptying the contents directly into the graduated cylinder or tared beaker. The volume is not less than the nominal volume in the case of containers examined individually or, in the case of ...
38、 or a translucent container may be made light-resistant by means of an opaque covering or by use of secondary packaging, in which case the label of the container bears a stateme nt that the opaque covering or sec on dary packagi ng is needed until the articles are to be used or ad...
Write down every USP you can think of and tell everyone in your organization about it. Writing it down gives a reference to go back to. Now that you know why people should buy from you you have to find them and educate them. In practice this means: ...
美国药典 USP31-NF26 无菌检查法《71》.doc 71 STERILITY TESTS 无菌检查法 Portions of this general chapter have been harmonized with the corresponding texts of the European Pharmacopeia and/or the Japanese Pharmacopeia. Those portions that are not harmonized are marked with symbols ( ) to specify ...