A3P

Connexion

Guidance on Handling of Insoluble Matter and Foreign Particles in APIs

This document was drawn up by a group of experts within CEFIC / APIC. 

The subject of particles (sometimes referred to as visible particles, insoluble particles /matter or foreign particles) in Active Pharmaceutical Ingredients (APIs) and related intermediates has been, and continues to be, a topic of great interest and importance to the pharmaceutical industry. Particles have always been present in APIs but the interest and concern has risen due to an increased number of inspectional observations from various Regulatory Authorities concerning visible particles in Drug Products and APIs.

The elevated presence of particles as well as inappropriate methods of investigation, controls and preventive and/or corrective actions were all subjects of citations by authorities and observations by API customers. 

Lire la suite...

USP Pharmacopeial : 41(5) In-Process Revision (SEP-OCT 2015)

“This section contains proposals for adoption as official USP or NF standards (either proposed new standards or proposed revisions of current USP or NF standards). These may be any of the following: (1) proposed revisions placed directly under In-Process Revision, or (2) modifications of revisions previously proposed under In-Process Revision. Readers should review material in this section and provide comments to the Scientific Liaison using the contact information appearing at the end of each proposal. Information on how to comment can be found under the “Participation” section of www.usp.org. It is important to send comments promptly, using the comment deadline listed after each title”

Lire la suite...

Q3D Elemental Impurities - Guidance for Industry

Elemental impurities in drug products may arise from several sources; they may be residual catalysts that were added intentionally in synthesis or may be present as impurities (e.g., through interactions with processing equipment or container/closure systems or by being present in components of the drug product). Because elemental impurities do not provide any therapeutic benefit to the patient, their levels in the drug product should be controlled within acceptable limits. There are three parts of this guidance: 

• the evaluation of the toxicity data for potential elemental impurities; 

• the establishment of a permitted daily exposure (PDE) for each element of toxicological concern; 

• and application of a risk-based approach to control elemental impurities in drug products. 

Lire la suite...

GMPs for APIs: “How to do” Document Interpretation of the ICH Q7 Guide

This document was written by experts from the European Industry (CEFIC APIC). It is essentially an interpretation of “how to” implement the ICH Q7 Guide based on practical experience. Other relevant publications (e.g. ISPE Baseline Guides, other ICH Guidelines) were taken into account and references included .

Lire la suite...

Visual Inspection of Medicinal Products for Parenteral Use

This paper aims to highlight best practice for carrying out visual inspection of medicinal products for parenteral use in the pharmaceutical industry. It should be seen as additional to and complimentary with the different Pharmacopoeias. Visual inspection of medicinal products for parenteral use should detect any readily identifiable visible container defect and ensure constant quality of the product in terms of absence of particular matter and/or turbidity, correct or uniform appearance of a lyo cake.

Lire la suite...

logo a3p-100pxhaut

 fren

S'engager pour partager
Transmettre et progresser ensemble
Promouvoir l'innovation

L’Association A3P est un acteur incontournable de l’industrie pharmaceutique et biotechnologique. 
Créée en 1986, elle contribue au bon développement de la production de médicaments et de matériels propres et stériles, elle anime un réseau de 21 000 professionnels, fabricants et fournisseurs, dans le cadre de Congrès internationaux et de journées techniques.

Elle regroupe aujourd’hui plus de 1700 adhérents qui partagent leurs expériences techniques, scientifiques et réglementaires.

 + d'infos en vidéo ( version gb ici )


  group    Administrateurs A3P
    
& Chargés de missions

letter   Newsletter A3P
NAVIGATEUR A3P est un outil regroupant la majorité des liens vers les textes, guides, documents et sites réglementaires pour les industries pharmaceutiques, biotechnologies et biomédicales.
  • BPF & Guides

  • Sites Pays

  • Sites Réglementaires

  • Domaines Pharma

  • Autres Sites

   Version 1.00                                                                                                               youtube   linkedin