GMP News - Analytical Quality Control

12.10.22

USP: Stimuli Article on Mutagenic Impurities published for Comments

Since the beginning of September 2022, the stimuli document "Mutagenic Impurities and Potentially Mutagenic Impurities in the USP-NF" has been published for comments on the USP Pharmacopeial Forum website. Comments and observations on this draft can be submitted until 30 November 2022.

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05.10.22

Ph. Eur. Cannabis Monograph Proposed for Comment

The European Pharmacopoeia (Ph. Eur.) published the long-awaited draft of the Cannabis flower monograph in Pharmeuropa with a comment period until 31 December 2022. Once finalized and adopted it is expected that the Ph. Eur. monograph will replace the currently existing national monographs.

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05.10.22

Revised Ph. Eur. Chapter on Rubber Closures

The final version of Ph. Eur. 3.2.9. Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders has been published in the European Pharmacopoeia (Ph. Eur.) 11.1. The supplement is now available and will become applicable as of 1 April 2023.

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28.09.22

Revised Ph. Eur. Chapter on Foreign Matter

The final version of Ph. Eur. 2.8.2 Foreign Matter in herbal drugs has been published in Ph. Eur. 11.1. The revised chapter clarifies that the quantitative limits for foreign matter only apply to foreign organs and foreign elements; other foreign elements should, as far as possible, be absent.

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28.09.22

USP publishes proposed Cannabis Monograph

A proposed monograph for Cannabis Species Inflorescence has been published in the USP Herbal Medicines Compendium (HMC). It is open for public comments for 90 days.

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28.09.22

USP-NF Stimuli Article on Analytical Method Precision Comparisons

In the Pharmacopeial Forum, PF 48(5), a stimuli article entitled "Analytical Method Precision Comparisons—A Special Case" was published. It addresses a statistical strategy that has been proposed to compare method precision during the transfer of a validated analytical procedure.

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21.09.22

Examples of Analytical Method Implementation

Following the recently introduced new Ph. Eur. chapter 5.26 Implementation of pharmacopoeial procedures, the EDQM published some examples to provide users with practical guidance. How can the critical factors potentially affecting the analytical procedure performance be identified?

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21.09.22

FDA Warning Letter: Potentially Carcinogenic Contaminants in Hand Sanitizers

The U.S. Food and Drug Administration (FDA) has again found genotoxic and potentially carcinogenic impurities in hand sanitizers. In this case, it is about an American manufacturer in whose products benzene, acetaldehyde and acetal impurities were detected at unacceptable levels.

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21.09.22

EDQM publishes FAQs on revised Ph. Eur. General Chapter 2.2.46. Chromatographic Separation Techniques

A revised general chapter 2.2.46. Chromatographic separation techniques has been published in Ph. Eur. 11.0. The implementation date is 01 January 2023. Due to numerous queries received through the EDQM HelpDesk, selected questions and answers have now been published. These complement the series of existing FAQs dealing with the European Pharmacopoeia and international harmonization.

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21.09.22

Revision of USP Chapter <541> Titrimetry

In the Pharmacopeial Forum, PF 48(5), a revision of USP chapter <541> Titrimetry is being proposed. Comments can be submitted until November 30, 2022.

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21.09.22

USP: Third Instrument Qualification Stimuli published for Comments

As of early September 2022, the Stimuli Document "Analytical Instrument and System (AIS) Qualification: The Qualification Life Cycle Process" has been posted for comments on the USP Pharmacopeial Forum website.

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21.09.22

EMA/CHMP: New Active Substance Guideline? Concept Paper published for Comments

Since the end of July, the "Concept paper on the revision of the guideline on the chemistry of active substances" of the CHMP's (Committee for Medicinal Products for Human Use) Quality Working Party (QWP) is available for public comments. This document aims to clarify the need to revise and update the guideline "Guideline on the chemistry of active substances (EMA/454576/2016)".

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14.09.22

FDA Warning Letter: Lab Data Integrity disregarded

In July 2022, the U.S. FDA issued a Warning Letter to the U.S. American company "Jost Chemical Co." after having inspected its site in January 2022. The Warning Letter mentions the list of cGMP observations for Active Pharmaceutical Ingredients (APIs).

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07.09.22

USP General Chapter <621> Chromatography: Delay of the Implementation of Two New Requirements

The revised USP General Chapter <621> Chromatography is scheduled to be official on 01 December 2022. The Chemical Analysis Expert Committee has now announced that the implementation of the sections titled "Peak Sensitivity" and "Peak Symmetry" under "System Suitability" will be delayed.

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07.09.22

EMA Publishes Comments Received on ICH Q2(R2) and Q14

In March 2022 the European Medicines Agency (EMA) published the ICH guidelines Q2(R2) on validation of analytical procedures and the ICH Q14 on analytical procedure development for public consultation. End of August, an overview of the comments received was provided.

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