Analytical Quality Control News

EDQM: Comments on the Nitrosamine Monograph possible

The updated text of the monograph "2.5.42. N-Nitrosamines in active substances and medicinal products" has been published on the website of the EDQM in the Pharmeuropa section and can be commented on until 31 March 2024, along with several other new drafts.

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FDA Warning Letter: Testing of incoming Goods

In January 2024, the U.S. FDA issued a Warning Letter to the company "Prime Lab LLC" after having inspected its site in July and August 2023. According to the WL, the firm failed to do proper incoming control tests for identity of their raw materials.

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FDA Warning Letter: Missing Stability Studies

In December 2023, the U.S. FDA issued a Warning Letter (WL) to the US American company "Inopak, Ltd." after having inspected its site in July and August 2023. According to U.S. FDA Warning Letter, the firm failed to maintain an ongoing stability program for their drug product.

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FDA Form 483: Calibration of Analytical Instruments

On 29 November 2023, a new FDA Form 483 that goes back to an inspection in October at a company in India was published. The 23-page report lists a total of 10 observations. Beside others, laboratory equipment including HPLCs, GCs, and UV Spectrophotometers used in commercial release and stability analysis were observed not meeting the calibration specifications.

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The new ECA Guide on Analytical Instrument Qualification and System Validation (AIQSV)

The ECA Analytical Quality Control Group (AQCG) has developed a new Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation. Version 1 of the new document is now available for download free of charge in the AQCG members' area.

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ICH Guidelines Q2(R2) "Validation of Analytical Procedures" and ICH Q14 "Analytical Procedure Development" published

After the final texts of the ICH Guidelines Q2(R2) and Q14 were adopted at the ICH Assembly Meeting on 31 October and 01 November 2023, the documents are now available for download on the ICH website.

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Outcome of the AQCG Board Meeting in November: New Board Member and Approval of the AIQSV Guide

The ECA Analytical Quality Control Group (AQCG) met in-person on 20 November 2023 in Düsseldorf/Neuss, Germany. During this Board Meeting, several decisions were made concerning both the composition of the Board and the work program for the coming months.

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FDA 483s due to Deficiencies in the Stability Program: Evaluation of Fiscal Year 2023

Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. The FDA has now published the data for the fiscal year 2023. As in previous years, we have again performed an evaluation with regard to deficiencies in the stability programme.

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FDA Warning Letter: Lack of Identity Testing and Stability Program

The U.S. Food and Drug Administration (FDA) has sent a Warning Letter to a manufacturer of over-the-counter (OTC) drug products. Based on a review of record, the authority found several CGMP violations. These concern inadequate identity testing of incoming components and finished drug products. Furthermore, an adequate stability testing program was not implemented.

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FDA Warning Letter: Inadequate Quality Systems

The U.S. FDA issued a Warning Letter to the US American company "ALI Pharmaceutical Manufacturing, LLC" after having inspected its site in September/October 2022.

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