- Published: Wednesday November 30 2016 09: 10
This guidance paper Describes and Explains the Food and Drug Administration's (FDA, we, us) That current regulation addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for device-related adverse events and some Malfunctions.
Circumstances That Constitute Delaying, Denying, Limiting, gold has Refusing Drug Inspection Guidance for Industry
- Published: Wednesday November 30 2016 09: 09
This guidance covers facilities That are subject to inspection under section 704 of the FD & C Act.2 This guidance olefins the type of action, inaction, and Circumstances que la FDA considers to Constitute Delaying, Denying, or limiting inspections, gold Refusing to permit entry or inspection for the Purposes of 501 section (j).
9e Edition of the European Pharmacopoeia: maintain quality standards in a globalized and dynamic environment
- Published: Wednesday August 24 2016 13: 42
The 9e Edition of the European Pharmacopoeia (Ph. Eur.) Was published in July 2016. Compared to the current edition, the edition consists 9e over 50% of new or revised texts, corresponding to the latest developments of a pharmaceutical world that is truly global, dynamic and rapidly changing.
In this video, Dr. Susanne Keitel, Director of the EDQM, explains how the Ph. Eur. continues to meet the challenges of the globalized world of today.
More information : https://www.edqm.eu/fr/9e-edition-de-la-ph-eur
- Published: Sunday November 6 2016 09: 10
This document has-been Prepared to assist companies in the formulation of cleaning validation programs and shoulds not be regarded as a technical standard goal starting points for internal discussions.
The paper includes examples on how member companies-have Dealt with specific areas and issues That Arise When performing cleaning validation.
- Published: Thursday July 21 2016 09: 10
The purpose of this paper is to describe the practical implementation of ICH Guideline for Q3D 9 Elemental Impurities in the European context.
In the ICH Guideline for Q3D elemental impurities, the focus of the control of elemental impurities is-shifted Compared to the CHMP Guideline on the Specification Limits for Residues of Metal Catalysts Gold Metal Reagents synthesis of the active substance. The form acknowledges That this is one of the MOST significant sources of elemental impurities, aim aussi takes into account --other sources and includes The Therefore Elements not used as Catalysts and reagents. The lath guideline Focuses on control of metals intentionally added During the synthesis of the active substance.