GMP News - Analytical Quality Control

02.11.23

EMA revises Guidance on Development, Production, Characterization and Specification for Monoclonal Antibodies and related Products.

In the context of technical and scientific developments in the field of certain products containing monoclonal antibodies, the EMA is revising its guidance document "Development, production, characterisation and specifications for monoclonal antibodies and related products" and other related documents.

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02.11.23

USP Briefing on Mass Spectrometry-Based Multi-Attribute Method for Therapeutic Proteins

Publications in the'USP Proposals PF 49_5 also include a draft chapter <1060> "Mass Spectrometry-Based Multi-Attribute Method for Therapeutic Proteins".

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26.10.23

Revised USP Chapter <660> Glass Containers

Following the previously issued draft for USP General Chapter <660> Containers – Glass, the final version of the chapter was published and made official on 1st October 2023. In particular, the revision to General Chapter <660> changed the "composition based" glass type definition to one that is "performance based".

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25.10.23

FDA Warning Letter for South Korean Manufacturer: Identity Testing, QU Oversight, Equipment Qualification and Maintenance

The U.S. Food and Drug Administration (FDA) has sent a new Warning Letter to a manufacturer located in South Korea. The firm manufactures over-the-counter (OTC) topical drug products, such as hand sanitizers. During an inspection, significant violations of Current Good Manufacturing Practice (CGMP) were found.

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10.10.23

USP HMC publishes revised Cannabis Draft Monograph

The USP Herbal Medicines Compendium (HMC) published a revised version of the previously proposed Cannabis Species Inflorescence monograph. In particular, the Content of Terpenes section has been removed from Specific Tests because there is insufficient information to support the use of terpenes for medical purposes.

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10.10.23

EDQM pre-publishes Ph. Eur. Cannabis Flower Monograph

As previously announced the new Ph. Eur. monograph Cannabis flower was adopted and will be published in Ph. Eur. Supplement 11.5 in January 2024. Now, the Ph. Eur. decided to make the monograph immediately available on the EDQM website for information.

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04.10.23

USP: Excipient Stimuli published for Comments

In the beginning of September, the stimuli document "Proposed Definitions of Excipient Components- Revisions to 2018 Definitions- PF 49(5)" was published for comment on the website of the Pharmacopeial Forum of the USP. Comments on this draft can be submitted until 30 November 2023.

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04.10.23

FDA Warning Letter for OTC Manufacturer in Arizona

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a U.S. OTC manufacturer. During an inspection, several CGMP violations were found.

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04.10.23

New USP Chapter: Wetting Properties of Pharmaceutical Systems

An expert group of the US Pharmacopoeia (USP) is working on a new chapter on wetting properties of pharmaceutical systems, which may have relevance for both batch and continuous manufacturing. The draft can be found in Pharmaceutical Forum PF49(5).

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27.09.23

USP: Chapter "Weighing on an Analytical Balance <1251>" published for Comments

Like the USP chapter "Balances <41>", the chapter "Weighing on an Analytical Balance <1251>" has been updated and revised. The new version of this chapter has now been posted on the USP Pharmacopeial Forum website for comment. Comments on this draft, which is based on the previous version from May 2018, can be submitted until 30 November 2023.

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27.09.23

Changes in Testing for Nitrate and Endotoxins in pharmaceutical Waters in the European Pharmacopoeia

In the Ph.Eur. Supplement 11.4, the EDQM announces the deletion of the test for nitrate in Water For injection (WFI) and Purified Water if the test for conductivity meets the pharmacopoeial requirement for WFI. In addition, the use of recombinant factor C (rFC) to test for bacterial endotoxins will be allowed. Find out more about the changes in the Ph.Eur. Monographs Water for Injection (0169) and Purified Water (0008).

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27.09.23

WHO Draft Working Document on Good Practices for Quality Control Laboratories published for Comments

The World Health Organization (WHO) has published a draft working document on "WHO good practices for pharmaceutical quality control laboratories (QAS/21.882)". The deadline for submitting comments is 06 October 2023.

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26.09.23

Ethylene and Diethylene Glycol Testing again in Focus of FDA Warning Letters

In recent months, the awareness for the impurities diethylene glycol (DEG) and ethylene glycol (EG) in pharmaceutical products was increased due to several FDA Warning Letters. We have reported on different examples where manufacturers failed to conduct proper identity testing of glycerin and other high-risk components. Now two more Warning Letters have been published, which also deal with this issue.

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20.09.23

Revised USP Chapter <31> and New Chapter <1331> on Volumetric Apparatus Published for Comments

In the Pharmacopeial Forum, PF 49(5), two USP chapters related to volumetric apparatus were published for comments. It is proposed to make several changes in Chapter <31> Volumetric Apparatus. Furthermore, a new general chapter <1331> Use and Calibration of Volumetric Apparatus has been developed.

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20.09.23

USP: Comments possible on the Topic "Balances <41>"

The latest valid version of the USP chapter "Balances <41>" has been substantially revised and is now posted for comment on the USP Pharmacopeial Forum website. This revision follows updates to the USP chapter "Weighing on an Analytical Balance <1251>" and the general chapter "Balances" of the European Pharmacopoeia (Ph. Eur.). Comments on this draft can be submitted until 30 November 2023.

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