Analytical Quality Control News

USP plans new General Chapter on Supercritical Fluid Chromatography (SFC)

The United States Pharmacopeia (USP) plans a new general chapter on Supercritical Fluid Chromatography (SFC), covering principles, practical application, and guidance for experimental setup. A preliminary outline has been published and public comments are invited until 28 May 2026.

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Ph. Eur.: Updated Guidelines for analytical Balances now available

In April 2026, the updated texts of Ph. Eur. 13.1 were published and listed on the EDQM website under the Ph. Eur. section. These include, for example, the revised general chapter '2.1.7. Balances for analytical purposes'.

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FDA Warning Letter: Batch Release Without Appropriate Laboratory Evidence

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter that refers back to an inspection at a Chinese drug manufacturing facility. At the center of the letter is an analytical compliance failure frequently cited in Warning Letters: release decisions without appropriate laboratory evidence.

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FDA Warning Letter - From Garbage Bags with Analytical Records to Pre-signed and Backdated Data

The FDA has issued a new Warning Letter, flagging systemic data integrity and quality failures at an Indian contract testing laboratory.

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CMDh/EMA: New Update to Appendix 1 on Nitrosamines

Appendix 1 of the EMA/CMDh Nitrosamine Q&A document 'Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products' was updated in March 2026.

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Reminder: OOS Survey - Participation possible until 8 April

As reported in our last newsletter, the ECA Analytical Quality Control Group (AQCG) is currently collecting input via a short survey to support the revision and update of its guidance on Out-of-Specification (OOS) investigations. Participation is still possible until 8 April.

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Questions and Answers on System Suitability Tests (SST) - Part 3

During the ECA Live Online Training “System Suitability Tests (SST) and Troubleshooting for HPLC Methods” on 04 November 2025, participants raised a number of interesting, practice-oriented questions. These were subsequently answered in writing by the speakers’ team. To share selected insights with a wider audience, we have compiled a selection of these Q&As. Read Part 3 here.

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Statistical Process Control (SPC) - Survey Result Report now Available

The ECA Validation Group recently conducted a survey on “How is Statistical Process Control (SPC) used in the pharmaceutical industry?”. The results have been compiled into a report, which is now also available to members of the Analytical Quality Control Group (AQCG).

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EDQM: How should the Specification of a Substance be Presented in a CEP Application?

A new question has been added to the FAQs section of the EDQM website under the subheading 'Application dossier'. You can find this in the section 'CERTIFICATION OF SUBSTANCES FOR PHARMACEUTICAL USE' under the main heading 'General information on the CEP procedure'. The new question reads: "How to present the specification for a substance in a CEP application?".

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How is the Validation of Analytical Methods Performed?

The validation of analytical methods is an essential component of Good Manufacturing Practice (GMP). It provides documented evidence that an analytical procedure is suitable for its intended purpose and consistently generates reliable, reproducible, and robust results under defined operating conditions.

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