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Guidance on Handling of Foreign Insoluble Matter and Particles in APIs

Was Ce document 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 continued to be, a topic of great interest and importance to the pharmaceutical industry. Particles-have-been always present in the APIs goal and interest due to concern Has Risen year Increased number of inspectional observations from various Regulatory Authorities concernant 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 action Were all subjects of quotes and comments by autorités by API customers.


USP Pharmacopeial: 41 (5) In-Process Revision (September-October 2015)

"This section contains Proposals for adoption as official USP or NF standards (Either Proposed Proposed new standards or revisions of current USP or NF standards). These May be'any of the Following: (1) Proposed revisions Placed Directly under In-Process Revision, gold (2) modifications of Previously Proposed revisions under In-Process Revision. Readers shoulds review material in this section and Provide comments to the Scientific Liaison using the contact details 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 significant to send comments aussitôt, using the comment deadline listed after-Each title "


Q3D Elemental Impurities - Guidance for Industry

Elemental impurities in drug products May Arise from several sources; They May be residual Catalysts That Were intentionally added in May synthesis or be present as impurities (eg, through interactions with processing equipment or container / closure systems by being white gold 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 shoulds be controlled Within acceptable limits. There are three parts of this guidance:

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

• the establishment of a permitted daily exposure (PDE) For Each element of Toxicological concern;

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


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

This paper was written by experts from the European Industry (CEFIC APIC). Essentially it is an interpretation of "how to" implement the ICH Q7 Guide is based practical experience. Other relevant publications (eg ISPE Baseline Guides, other ICH Guidelines) Were taken into account and included references.


Visual Inspection of Medicinal Products for Use Parenteral

This paper AIMS to highlight best practice for carrying out visual inspection of medicinal products for parenteral use in the pharmaceutical industry. It shoulds be seen as additional to and complimentary with the different Pharmacopoeias. Visual inspection of medicinal products for parenteral use shoulds detect Any identifiable Readily visible defect and container Ensure constant quality of the product in terms of lack of Particular matter and / or turbidity, or proper uniform appearance of a lyo cake.


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