Analytical Quality Control News

Bioactivity Testing for ATMPs

Especially for modern pharmaceutical products such as ATMPs, the development and validation of potency assays is characterised by a number of challenges, which are summarised in the following article ‘Bioactivity testing for ATMPs’.

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EMA/CMDh: Q&A Document Nitrosamines revised

In July 2024, the nitrosamine Q&A document "Nitrosamines EMEA-H-A5(3)-1490 - 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 revised again and published on the EMA website under "Questions and answers".

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EDQM: Availability of Reference Substances

The list of available reference standards is regularly revised and published on the EDQM website. The list comprises more than 3,000 substances, including chemical reference substances, herbal reference standards and biological reference preparations as well as reference spectra for carrying out tests and trials according to Ph. Eur. methods.

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FDA Warning Letter: Inadequate Lab Testing Procedures

In August 2024, the U.S. FDA issued a Warning Letter (WL) to the Chinese company "Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd." after having inspected its site in December 2023. According to U.S. FDA Warning Letter, the firm failed to implement appropriate release specifications and analytical procedures for some of their drug products.

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FDA Warning Letter to a Manufacturer of an Athlete Muscle Maintenance Creme

At the beginning of July, the FDA published a Warning Letter due to a lack of chemical and microbiological controls in the manufacture of a product for dermal application and inadequate testing of the ingredients used.

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FDA Warning Letter - Missing incoming Control Tests

In June 2024, the U.S. FDA issued a Warning Letter to the Portuguese company "Fancystage Unipessoal, LDA" after having inspected its site in January 2024. According to U.S. FDA Warning Letter, the firm failed to do proper incoming control tests to identity the goods.

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CMDh/EMA: Appendix 1 for Nitrosamines updated again

In July 2024, new substances were added to Appendix 1 of the 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" and some existing entries in the list were updated.

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EMA/CMDh: Update of Appendix 1 for Nitrosamines

Appendix 1 "Acceptable intakes established for N-nitrosamines" of 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" was prepared by the "Non-clincal Working Party (NcWP)" and in May 2024 sixteen new substances were added and two entries were updated.

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ICH Q3C: New Version of the Guideline for Residual Solvents published

Since the end of April 2024, the ninth revision of the "IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS Q3C(R9)" of the ICH has been available on the ICH website under the heading "Quality Guidelines". This version includes revisions and adjustments in section 3.4 Analytical Procedures.

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FDA Warning Letter to Contract Testing Laboratory in Uruguay due to Data Integrity Violations

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a contract testing laboratory in Uruguay. The inspection revealed significant CGMP violations, specifically related to the laboratory data integrity and documentation practices. Key issues included incomplete laboratory records, unreviewed out-of-specification (OOS) results, and lack of controls over electronic data and manual integrations.

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