Analytical Quality Control News

Missing Tests and Altered Records: FDA Warns Chinese OTC Manufacturer

A recent FDA Warning Letter to a Chinese OTC manufacturer highlights serious deficiencies in analytical testing, inadequate quality oversight, and multiple data integrity issues. These include missing data, discrepancies between original and re-written testing records and certificates of analysis (COAs), and the use of correction fluid (white-out) to alter laboratory documentation.

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Become a speaker at PharmaLab 2025 - Analytics, Bioanalytics, Microbiology and more

The 13th PharmaLab Congress from November 24-28, 2025 will take place as usual in Neuss/Düsseldorf with two pre-conference workshops and several parallel conferences. As always, it offers you the opportunity to become part of the speaker team and submit a presentation to share your knowledge with colleagues and discuss the respective experiences. So, become part of the team of speakers - and submit your proposal for a presentation via our online form.

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Inadequate Dissolution Testing and Process Validation Trigger FDA Warning Letter

The U.S. Food and Drug Administration (FDA) has issued a new Warning Letter due to CGMP violations related to combination products. Key violations include inadequate controls to ensure the sterility of drug products, deficient dissolution testing, and a lack of process validation.

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WHO: Update of Guideline of Reference Standards

The WHO recently published the “Working document QAS/25.972” of the “WHO General guidelines for the establishment, maintenance and distribution of chemical reference substances” on the subject of reference standards on its website for comments. The comment period is scheduled to last until May 7, 2025.

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FDA issues Warning Letter due to GMP Violations at Chinese Drug Manufacturer

The United States Food and Drug Administration has issued a Warning Letter to a Chinese manufacturer. The violations include inadequate raw material testing and insufficient stability testing programs.

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CMDh/EMA: Appendix 1 for Nitrosamines Revised

Appendix 1 to the nitrosamine Q&A document "Questions and answers for marketing authorization 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" of the EMA/CMDh was updated in February 2025.

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USP-NF Stimuli Article on Analysis of Residual Solvents

In the Pharmacopeial Forum, 51(2), a Stimuli Article entitled "Direct Analysis of Class 2 Residual Solvents Using Molecular Rotational Resonance Spectroscopy" has been published. The study focuses on the development and validation of a continuous headspace-MRR method for analyzing selected Class 2 residual solvents.

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EMA publishes Considerations regarding the Implementation of ICH M13A on Bioequivalence

The European Medicines Agency (EMA) has published a new document entitled "Considerations regarding the implementation of ICH M13A on bioequivalence for immediate-release solid oral dosage forms".

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Further Modifications to USP Chapter <621> Chromatography Published for Comment

In the Pharmacopeial Forum, PF 51(2), a new version of USP General Chapter <621> Chromatography has been published. The System Sensitivity and Peak Symmetry subsections were further modified to clarify the applications of these new requirements. Comments can be submitted until 31 May 2025.

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WHO: Updates on Method Transfer

In 2022, the WHO published the "Technical Report Series 1044, 2022" called "TRS 1044 - Annex 4: WHO guidelines on technology transfer in pharmaceutical manufacturing" on the subject of technology transfer.

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