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. 

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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”

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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. 

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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 .

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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.

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