Analytical Quality Control News

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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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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New EMA Reflection Paper on the use of Artificial Intelligence

On 19 July 2023, the EMA (European Medicines Agency) published a Reflection Paper on the use of Artificial Intelligence (AI) in the medicinal product  lifecycle. This document is open for comments until 31. December 2023. What is the content of the document?

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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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EDQM: Excipient Monographs

Supplement 11.2 to the European Pharmacopoeia (Ph.Eur.) came into force on 01 July 2023 and contains several updated monographs. These include five updated excipient monographs, which now include the so-called "functionality-related characteristics (FRCs)" section. In total, there are now more than 100 Ph.Eur. Monographs that include this section.

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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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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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FDA Warning Letter: Inadequate API testing

In March 2023, the U.S. FDA issued a Warning Letter to the US American company "Omega Packaging Corp" after having inspected its site in October and November 2022.

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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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CMC: FDA publishes Guideline with questions on post-approval modification of single-use materials

With the publication of a question and answer guideline, the FDA is responding to the challenges of the shortage of disposable materials in manufacturing and the requirements for the use of alternative materials in the area of chemistry, manufacturing and controls (CMC).

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