Analytical Quality Control News

USP-NF Stimuli Article on Stability of Compounded Preparations

The stability of a compounded preparation has several factors that must be evaluated by compounders utilizing or developing stability studies to determine the Beyond-Use Dates (BUDs). In this context, a Stimuli article entitled "Stability Reference Document for Pharmaceutical Compounding" was published in the Pharmacopeial Forum, PF 50(6).

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FDA Warning Letter: Pest Activity, Water Leaks, and Misuse of QC Laboratory in U.S. Drug Manufacturing Facility

The U.S. Food and Drug Administration (FDA) has recently published a new Warning Letter. The authority observed pest activity in the raw storage area, water leaks, and missing ceiling tiles in the drug manufacturing area. Furthermore, employees used the QC lab for non-CGMP activities, such as meal preparation and dishwashing.

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EDQM publishes New Chapter "Quality of Data" for Comments

The draft of the new chapter '5.38. QUALITY OF DATA' has been published on the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare) in the Pharmeuropa section and can be commented on until 31 December 2024, along with several other new drafts.

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US FDA Warning Letter: Lab Data Integrity issues

In September 2024, the U.S. FDA issued a Warning Letter to the Indian company "MMC Healthcare Ltd." after having inspected its site in March 2024. According to the Warning Letter, the firm failed to have "appropriate controls to assure the integrity of electronic test data, such as an audit trail and defined user access levels".

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Management circumvents Quality Department in Deviation Classification - FDA Warning Letter

In a Warning Letter to a manufacturer of non-sterile drugs in the USA, the FDA summarises a whole series of deficiencies. Serious deficiencies were found both in microbiological control and deviation handling as well as in analytics.

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EC: New Requirements for 'PFAS' Subgroup adopted

In September, the European Commission announced the newly adopted restrictions for 'PFHxA' (undecafluorohexanoic acid), its salts and PFHxA-related substances and published them on its website. The new regulations are reported here in a communication as well as in the Official Journal of the European Union.

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US FDA Warning Letter: Testing of incoming Goods

End of August 2024, the U.S. FDA issued a Warning Letter to the company "Orean Personal Care Ltd." after having inspected its site in March 2024. According to the Warning Letter, the firm failed to do proper incoming control tests for identity of their raw materials.

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Host Cell Proteins - FDA seeks Comments on Immunogenicity Assessment

The issue of residues of host cell proteins (HCPs) plays an important role in the manufacture of peptide products. In July, the FDA called for comments via the Federal Register to help assess the immunogenicity risk of such HCPs.

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FDA: Updated Guidance for Nitrosamines

In September 2024, the U.S. FDA published Revision 2 of the document 'Control of Nitrosamine Impurities in Human Drugs' on its website. This 'Guidance for industry' replaces the previous version of 24 February 2021, and was published without a comment period so that comments can still be submitted now.

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USP: Commenting on 'Balances <41>' and 'Weighing on an Analytical Balance <1251>' possible again

The chapters 'Balances <41>' and 'Weighing on an Analytical Balance <1251>' of the USP have been revised again and published on the website of the USP Pharmacopeial Forum for comments. The previous drafts have been discarded. Comments and remarks on these drafts can be submitted until 30 November 2024.

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