Analytical Quality Control News

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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European Pharmaceutical Review Article on ICH Q2(R2)

In the European Pharmaceutical Review, a new article entitled "Advancements and knowledge gaps in ICH Q2(R2)" was published. In their article, the authors explore the latest advancements in ICH Q2(R2) guidelines on validation of analytical procedures and their implications for industry. The authors include members of the ECA Analytical Quality Control Group Advisory Board.

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Q&As from the Live Online Training "Introduction to the AQCG's new AIQSV Guide" - Part 1

During the ECA Live Online Training "Introduction to the AQCG’s new ECA Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation" on 29 April 2024, many interesting aspects were discussed in the Q&A session. We have compiled a selection of the questions with the teaching team's answers. You can read Part 1 here.

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USP: <11> Reference Standards - Draft published for Comment

The new draft of the monograph "<11> USP REFERENCE STANDARDS" has been published for comment on the website of the USP Pharmacopeial Forum since the beginning of May 2024. Comments and observations on this summary can be submitted until 31 July 2024.

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Further Warning Letter with multiple Deviations to a Korean Company

The series of FDA inspections with multiple deviations continues with another Warning Letter to a Korean company. In this case too, inadequate analytical control of starting materials and raw materials, e.g. for ethylene and diethylene glycol, is part of the deviation list.

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USP Responses to Instrument Qualification Stimuli published for Comment

Since the beginning of May 2024, the stimuli document 'USP Responses to Comments for Stimuli Articles on Analytical Instrument and System (AIS) Qualification' has been published for comment on the USP Pharmacopeial Forum website. Comments and observations on this summary can be submitted until 31 July 2024.

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FDA Warning Letter: Missing Identification Tests

In March 2024, the U.S. FDA issued a Warning Letter to the company "Master Paints & Chemicals Corp." after having inspected its site in October 2023. According to the Warning Letter, the firm failed to do proper incoming control tests to identity their raw materials.

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FDA Form 483 lists 10 Observations made during an Inspection of an Indian Drug Manufacturer

On 09 April 2024, a new FDA Form 483 to a company in India was published. The document lists a total of 10 observations made by the FDA investigators during the inspection in March 2024 of the firm's facility located in Baddi.

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