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Reporting for Medical Device Manufacturers Guidance for Industry

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

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


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


APIC Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants

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.


Implementation strategy of ICH guideline EMA Draft Q3D

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.


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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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BROWSER A3P is a tool comprising the majority of links to texts, guides, regulatory documents and websites for the pharmaceutical, biotechnology and biomedical.
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