GMP News - Analytical Quality Control

20.07.23

Ph. Eur. Update on Pharmaceutical Preparations

A revised version of the Ph. Eur. general monograph Pharmaceutical Preparations has been published. In particular a reference to the general Ph. Eur. chapter Contaminant pyrrolizidine alkaloids (2.8.26) has been added.

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19.07.23

FDA Warning Letter issued due to no response

In June 2023, the U.S. FDA issued a Warning Letter to the Chinese company "Chengdu KeCheng Fine Chemicals Co., Ltd.". According to the Warning Letter, the company is registered within the USA as an API manufacturing facility, which shipped APIs to the U.S. several times.

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19.07.23

EMA publishes new and updated product-specific Bioequivalence Guidance

The European Medicines Agency (EMA) has published new or updated product-specific guidelines for the demonstration of bioequivalence.

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19.07.23

Auxiliary Packaging Components

The USP adopted the revised general chapter <670> Auxiliary Packaging Components. In particular a new category "odor adsorbent" has been added.

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11.07.23

How to determine the Protective Properties of Amber Glass Containers?

Colored glass containers are usually used to contain light-sensitive drug products. A previously issued USP Stimuli Article on the measurement of the protective properties of colored glass containers has now been republished. The article provides proposed maximum allowed specific transmission values for colored glass containers.

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11.07.23

Pharmeuropa: Revised Chapter 2.2.47. "Capillary electrophoresis" published for Comments

In the Pharmeuropa issue 35.3, a proposal for a revised chapter 2.2.47 "Capillary electrophoresis" was published. The deadline for submitting comments is 30 September 2023.

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27.06.23

New Edition of the Herbal Guide

The EDQM has published a new edition of the Guide for the elaboration of monographs on herbal drugs and herbal drug preparations. The Guide provides general guidance on the structure of Ph. Eur. monographs of herbal drugs and herbal drug preparations and on the information to be included in them. In addition, principles for the preparation and revision of herbal monographs are explained.

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27.06.23

Cannabis Reference Standards DAB

The amended German Pharmacopoeia (Deutsches Arzneibuch, DAB) is valid from 1 August 2023. The DAB 2023 now includes several revised texts for Cannabis reagents.

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21.06.23

Korean MFSD publishes Revision 7 of Comparative Dissolution Test Guideline

The Korean Ministry of Food and Drug Safety (MFDS) has revised the "Guidelines for Comparative Dissolution Test". A new version dated 18 May 2023 was published.

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20.06.23

USP <88> "Biological Reactivity Tests, In Vivo" is currently also undergoing Revision

In the course of the revision of the Chapter on biological reactivity the USP has also published a draft of chapter <88> on in vivo tests. This news presents a summary of the changes.

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31.05.23

FDA Form 483 due to Insufficient Investigations after OOS and OOT Results

The U.S. Food and Drug Administration (FDA) has published a Form 483. During an inspection at an Indian drug manufacturing side, several CGMP violations were documented. These concerns, among others, Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, where results were invalidated by retesting the batches without a scientifically justified root cause.

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24.05.23

APIC: ICH M7 "How to Do" Document published

The first version of the "Sharing Drug Substance M7 information to HA and MAH: "How to do" document -Interpretation of the ICH M7 guideline and other relevant guidelines with regard to M7 data sharing" and the associated templates were finalised in March and April 2023 and are now available on the APIC website.

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24.05.23

USP: Chapter "<2> Oral Drug Products - Product Quality Tests" published for Comments

Since the beginning of May 2023, the chapter <2> Oral "Drug Products - Product Quality Tests", which is part of the heading "General Tests & Assays", has been published for comments on the website of the Pharmacopeial Forum of the USP. Comments and remarks on this draft, which is based on the previous version from August 2020, can be submitted until 31 July 2023.

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17.05.23

Draft of USP Chapter <711> Dissolution (PDG harmonized document) Published for Comments

In the Pharmacopeial Forum, PF 49(3), a proposal of a revised USP General Chapter <711> Dissolution has been published for comments. The background to the publication is the efforts of international harmonization of monographs and general analytical methods of the European, Japanese, and United States pharmacopeias. The new draft represents the Pharmacopeial Discussion Group (PDG) harmonized document.

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17.05.23

Revision of USP Chapters <782> Vibrational Circular Dichroism Spectroscopy and <1782> Vibrational Circular Dichroism Spectroscopy - Theory and Practice

In the Pharmacopeial Forum, PF 49(3), proposals of revised USP General Chapters <782> Vibrational Circular Dichroism Spectroscopy and <1782> Vibrational Circular Dichroism Spectroscopy - Theory and Practice were published for comments.

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