Article archive

EMA Guideline on Quality of biological active Substances produced by transgene Expression in Animals

17/10/2013 00:11
In May 2013 the CHMP adopted the Guideline on Quality of biological active substances produced by transgene expression in animals. The date for coming into effect is the 1 December 2013. It will replace the guideline on ‘Use of transgenic animals in the manufacture of biological medicinal products...

Stability Testing of Generics: FDA publishes Q&A Document

17/10/2013 00:08
In June 2013, the FDA published a "Guidance for Industry" entitled "ANDAs: Stability Testing of Drug Substances and Products" which describes the requirements on stability data needed in a marketing authorisation application for generic drugs (see our GMP News from 1st August 2013). With regard to...

Authorisation of Generic Drugs in the USA: Requirements on APIs Stability Data for US Drug Master Files

17/10/2013 00:05
According to the new Generic Drug User Fee Act (GDUFA) for the marketing authorisation of generic drugs in the USA, the Drug Master File (Type II) for APIs must undergo a completeness assessment (see our GMP News from 11 October 2012). The approach is described in the Draft Guidance for Industry...

"Sister File Procedure": New Fast-Track Procedure for the Application of Further CEPs for the Same API

17/10/2013 00:00
In addition to an already existing Certificate of Suitability (CEP), a CEP holder may have good reasons to apply for a further CEP for the same substance, when for example: The specifications of the final substance obtained with an alternative process cannot be covered by the existing CEP (i.e....

EMA published Concept Paper on the Revision of the Finished Dosage Form Guideline

16/10/2013 23:54
The Guideline mentioned in the title aims to cover the EU Directive on the manufacture of medicinal products in more details and interpret it. This is one of the main reasons why the Guideline has been revised. In its last version from 1996, the Guideline referred to the former Directive which has...

FDA published Guideline Draft on the Registration of Production Sites

16/10/2013 23:49
FDA's initiative to identify production sites according to a uniform system. The identification should be enabled thanks to a D-U-N-S- (Data Universal Numbering System) number (composed of 9 figures) allocated by the company Dun & Bradstreet. The topic seems to be crucial for the FDA as it has...

Revision of USP Chapter on IR Spectroscopy

16/10/2013 23:43
In the Pharmacopeial Forum No 39(2), the USP has published the draft for the revised General Chapter <854> on Mid-Infrared Spectroscopy. This draft is the second one and takes into consideration the comments sent to the USP. Some acceptance criteria for some of the single validation...

FDA publishes revised Guidance for Applicants of Marketing Authorisations for Generics

16/10/2013 23:41
The GDUFA (Generic Drug User Fee Act), the new act on fees due for the processing of marketing authorisation applications and the inspection of production sites came into force on 9 July 2012. This serves the accelerated processing of marketing authorisation applications for generic products and...

FDA Warning for Inadequate Storage of Reference Samples and Reagents

16/10/2013 23:38
  Reference Samples and reagents should be stored according to manufacturers recommendations to maintain the required quality. FDA verifies storage conditions during inspections This became clear during an inspection of a drug manufacturer which resulted in a 483 with 12 observations....

USFDA Draft Guidance - Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection

16/10/2013 23:26
New Draft Guidance - Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection
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