Analytical Quality Control News

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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FDA Warning Letter: Missing Ongoing Stability Studies for APIs

In April 2024, the U.S. FDA issued a Warning Letter on its webpage to the Australian company "Antaria Pty. Ltd." after having inspected its site in November 2023. According to the Warning Letter the company missed to have an appropriate stability program for its API in place.

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USP plans new Chapter on Process Analytical Technology (PAT)

The United States Pharmacopeia (USP) is developing a new General Chapter dedicated to Process Analytical Technology (PAT), aiming to provide guidance on its definition, attributes, enablers, and practical applications in the pharmaceutical industry. Comments on the proposed outline are due to the USP by 28 April 2024.

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The new AQCG ECA AIQSV Guide: Download, Training, Comments

The ECA Analytical Quality Control Group (AQCG) has developed a new Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation. It is intended to be a practical guide for risk-based instrument qualification and system validation.

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