2 美国OTC专论制定的程序 纳入OTC专论的药品遴选审评依照美国联邦法规第21篇“食品与药品”条款(Code of FederalRegulations,Title 21 Food and Drugs,21CFR) 第330部分“通常公认为安全有效的非处方药(over-the-counter human drugs which are generally recognized...
On December 5, 2019, your firm shipped the over-the counter (OTC) drug product “(b)(4)” three days before you received the certificate of analysis (COA) with assay results from your contract laboratory for the active ingredient, (b)(4). While you received the COA on December 20, 20...
For non-application drugs, such as over-the-counter monograph products, the manufacturer must also conduct stability testing to establish an expiration date and storage conditions to meet FDA’s regulations (see 21 CFR 211.166 as well as related sections 211.137 and ...
Your firm released and distributed the over-the-counter (OTC) drug product, (b)(4), to the U.S. on (b)(4), without adequate final product testing. Your batch (b)(4) release document, dated August 14, 2019, recorded an assay result of (b)(4)% (specification (b)(4) – (b)(...
The article reports on the announcement of the U.S. Food and Drug Administration (FDA) concerning its plan of holding a meeting from March 25-26, 2014 in relation with the possible adjustment of the over-the-counter (OTC) drug regulations.EBSCO_AspPharmacy Times...
2.1 药品（Prescription and Over-the-Counter Drugs）监管法规：FDA通过《联邦食品、药品和化妆品法案》（FD&C Act）以及后续修正案，《科夫欧-哈里斯修正案》等，监管药品的生产、分销、标签和广告。主要要求：所有药品必须经过FDA审查和批准。药品的批准程序包括安全性和有效性的临床试验数据、质量控制措施、生产设施...
You used (b)(4) to manufacture your over-the-counter topical sunscreen drug products. Your firm failed to adequately investigate microbial out-of-limit (OOL) results from your (b)(4) system. For example, water sampled from (b)(4) on September 30, 2019, yielded an OOL result. Pseudomona...
otc是over the counter的缩写,即非处方药,是指那些不需要医生处方,消费者可直接在药房或药店中即可购取的药物。美国药品食品管理局(FDA)和海关(以及大多数其他进口国家)要求任何想要进出口的本地或者外国的制造商和经销商必须要有一个当地的代理机构能够负责向FDA /NDC和海关进行申报,负责解答有关他们的产品的法律...
An adequate QU overseeing all manufacturing operations is necessary to consistently ensure drug quality. 必须有充分的QU来监督所有生产操作,以始终如一地确保药品质量。 Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for ...
Your firm failed to perform critical quality control tests of finished drug products prior to shipment to the U.S. market. For example, our inspection found you lacked identity and strength testing for each batch of your over-the-counter (OTC) finished drug product "(b)(4)"for its labeled...