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又是数据完整性：CADILA印度厂现行收到FDA警告信2016-01-22 蒲公英。Current FDA Warning Letter for Manufacturer Cadila in India.CADILA印度厂现行收到FDA警告信。FDA刚于2015年12月23日，给CADILA印度厂签发了警告信（原料药和制剂两个工厂）。The FDA has required a comprehensive CAPA plan within 15 workings days on receipt of the ... 阅118 转2 评0 公众公开 16-01-22 11:23 |
New FDA Inspection Guidance gives the Agency more Power."A facility does not provide the FDA investigator access to aseptic processing areas until the investigator accommodates the facility''s documented gowning procedures. The FDA investigator requests translation of the records into English, and the tra... 阅62 转0 评0 公众公开 14-11-19 10:02 |
Major Reorganisation at FDA will affect GMP Inspections.In the center of the reorganisation, the FDA will introduce the new Office of Pharmaceutical Quality (OPQ).The new organisation will have a major impact on all inspections performed by FDA. With this step, FDA wants to improve the efficiency of its enforcement ac... 阅80 转0 评0 公众公开 14-11-19 09:59 |
FDA publishes new Guidance on Validation of Analytical Methods.Yet, new chapters have been added, like chapter "VIII. Life cycle management of analytical procedures" and its following chapter on the verification of analytical methods in FDA''s own laboratories ("IX: FDA methods verification"... 阅162 转0 评0 公众公开 14-03-26 10:29 |
What is FDA Readiness exactly?All pharmaceutical quality systems in operative units must be at such a high level that they would be ready for an inspection by the US American Health Agency - FDA - without any major preparations.those are always ready and prepared to welcome inspectors and accompany them through an ins... 阅40 转0 评0 公众公开 14-03-26 10:23 |
GMP News: "Reception denied!"The payment of the fees for a Drug Master File is equally important and necessary in accordance with GDUFA. If this fee was not paid, the DMF does not become available for the reference list and the generic authorisation application is handled as if the DMF were basically "n... 阅83 转0 评0 公众公开 14-03-26 10:02 |
Stability Testing of Generics: FDA publishes Q&A Document.General requirements on stability data Stability data in the Drug Master File Stability and packaging: various dosage forms Amendments to pending ANDA applications.ICH stability guidances should be followed. 6 months of accelerated data are recommended at t... 阅173 转3 评0 公众公开 13-09-29 16:14 |
This is a one-time fee for each individual DMF. This fee is due no later than the date on which the first generic drug submission is submitted that references the associated DMF. If a DMF has successfully undergone an initial completeness assessment and the fee is paid, the DMF will be placed on a publicly available l... 阅72 转0 评0 公众公开 13-09-17 15:16 |
FDA各种表格介绍。The EIR is then examined by the responsible Center or District Office of the FDA, issueing the following statuses:NAI: No Action Indicated - there were no objectionable items found during the inspection VAI: Voluntary Action Indicated - objectionable items were found, but no action is required on the... 阅2317 转18 评0 公众公开 13-08-28 09:26 |
