GMP News - Analytical Quality Control

18.08.21

FDA Warning Letter Highlights the Importance of Analytical Methods Validation and System Suitability Tests

In a recently published Warning Letter sent to a Chinese company, the FDA criticises, among other aspects, that analytical test methods were not adequately validated and no system suitability requirements were present.

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11.08.21

FDA Analyses Products from Amazon and Finds Potentially Harmful Drug Ingredients

The U.S. Food and Drug Administration (FDA) has purchased different products intended for sexual enhancement and weight loss offered for sale on amazon's website. In subsequent laboratory analysis, it was determined that all tested products contain undeclared and potentially harmful drug ingredients. In a letter dated July 26, 2021, sent to Amazon CEO Andy Jassy, the FDA requires Amazon to take measures to prevent such violations in the future.

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04.08.21

Proposed new USP Chapter <1095> Batch Release Testing for Ensuring Compliance with Uniformity of Dosage Units

In the Pharmacopeial Forum, PF 47(4), a proposal of a new USP Chapter <1095> Batch Release Testing for Ensuring Compliance with Uniformity of Dosage Units, addressing the common use of Uniformity of Dosage Units <905> as a batch release test, has been published for comments.

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28.07.21

Revision of USP <1099> Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples

In the Pharmacopeial Forum, PF 47(4), a proposal of USP Chapter <1099> Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples has been published for comments.

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28.07.21

Protective Properties of Colored Glass Containers

USP´s General Chapters–Packaging and Distribution Expert Committee (GCPD EC) proposes to replace spectral transmission with spectral absorbance for amber glass containers based upon wall thickness.

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21.07.21

Revision of USP <857> Ultraviolet-Visible Spectroscopy and <1857> Ultraviolet-Visible Spectroscopy - Theory and Practice

In the Pharmacopeial Forum, PF 47(4), proposals of USP Chapters <857> Ultraviolet-Visible Spectroscopy and <1857> Ultraviolet-Visible Spectroscopy—Theory and Practice have been published for comments.

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21.07.21

10th Edition of The International Pharmacopoeia

The 10th Edition of The International Pharmacopoeia is now available online. It contains recommended procedures for analysis and specifications for APIs and dosage forms.

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14.07.21

Q&A Document on Nitrosamine Impurities Updated

The latest revision of the EMA's question and answer document on nitrosamine impurities in medicinal products includes clarifications of some important issues. Read more here about the requirements for reporting nitrosamine impurities to regulatory authorities and the current deadlines for this.

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16.06.21

Ph. Eur. General Notices Chapter - New Structure and Content

The European Pharmacopoeia Commission adopted a revised version of Ph. Eur. chapter 1. General Notices to provide greater clarity for users.

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09.06.21

Foreign Matter in Herbal Drugs

A revised version of Ph. Eur. Chapter 2.8.2 Foreign Matter is available. It clarifies the requirements for other foreign matter like moulds and animal contamination and any other unwanted matter (e.g. glass, metal, plastic).

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02.06.21

New USP Chapter on Visual Inspection of Parenterals?

In the current Pharmaceutical Forum PF 47(3), a Stimuli article describes the weaknesses in the current specifications for testing parenterals for particles and how these could be addressed in a new USP chapter.

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26.05.21

APIC: Update of the Template for Potential Nitrosamine Contaminations

The latest version of the "REPORT ON THE RISK OF POTENTIAL PRESENCE OF NITROSAMINE IMPURITIES" has been available on the APIC website since April 2021. The questionnaire is to be seen as a summary report and can be used to document the results of the risk assessments with regard to contamination by nitrosamines in APIs.

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26.05.21

FDA adopts ICH Q12

The FDA adopted the ICH Q12 Guideline for post-approval change management. The guideline is intended to complement the existing ICH Q8 to Q11 Guidelines. It is composed of a Core Guideline and two Annexes with practical examples for ECs and PACMPs.

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26.05.21

Revision of USP <781> Optical Rotation

In the current Pharmacopeial Forum, PF 47(3), a proposal of USP Chapter <781> Optical Rotation has been published for comments.

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19.05.21

Revision of USP <831> Refractive Index

A new draft of USP Chapter <831> Refractive Index has been published for comments in the current Pharmacopeial Forum, PF 47(3).

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