Your firm failed to provide adequate oversight and ensure the reliability of data related to the quality of finished drug products manufactured at your facility. For example, our inspection documented serious quality assurance (QA) deficiencies, such as d...
警告信 The U.S. Food and DrugAdministration (FDA) inspected your drug manufacturing facility, Alchymars ICMSM Private Limited at A-14 & 20 Complex, Alathur, Tamil Nadu, from September 11 to 15, 2017. 2017年9月11-15日,美国FDA检查了你们位于印度泰米尔纳德邦的生产场所。 This warning letter s...
GMP（Good Manufacturing Practices）是药品生产质量管理规范，中国、欧盟、PIC/S国家和世界卫生组织，药品生产质量管理规范被称为GMP。而美国FDA称其为CGMP（Current Good Manufacturing Practices），为什么会有如此区别呢？FDA是这样解释CGMP的。Pharmaceutical Quality affects every American. The Food and Drug Administrat...
We are concerned with the CGMP violations demonstrated at your facility and failure to submit FAR-related events within three days of becoming aware of a problem. Please include in your written response the corrective action you plan to take regarding distributed products manufactured at your facility...
FDA’s guidance documentData Integrity and Compliance With Drug CGMPfor guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-dru...
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA's guidance document Data lntegrily and Compliance with Drug CGMP for guidance on establishing and following CGMP compliant data ...
该警告信总结了严重违反制剂CGMP规定的情况。请参阅21CFR第210和211部分。 Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192)...
CGMP法规的第211.165(e)部分说应建立并记录分析方法的准确性、灵敏度、专属性和重复性。还有,第211.166(a)(3)部分要求稳定性分析方法是可靠的、有意义的以及具有专属性,这意味着可以准确测定制剂中活性成分、产物和其它有意义成分的含量,而不受到干扰,通常被称为“稳定性指示性”。
FDA also relies upon reports of potentially defective drug products from the public and the industry. FDA will often use these reports to identify sites for which an inspection or investigation is needed. Most companies that are inspected are found to be fully compliant with the cGMP regulations....
Extent of this practice and how you will fully secure other CGMP computer systems in your facility. 这种做法的程度,以及你们将如何完全保护你们工厂其他CGMP计算机系统。 3. Your firm failed to establish the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e...