GMP News - Analytical Quality Control

22.09.21

New FDA Draft Guidance for Industry on Bioequivalence Studies

The FDA has published a draft guidance for industry entitled “Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.” The document provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. The FDA recommends that in vivo BE studies are accompanied by in vitro dissolution profiles. Under certain circumstances, BE can be evaluated alone by using in vitro approaches (e.g., dissolution testing).

08.09.21

EMA adopts final Public Statement on Pyrrolizidine Alkaloids

The HMPC adopted the final Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination with PAs. Amongst others, it is stated that PA specifications are no longer considered necessary for essential oils.

08.09.21

API Testing in the Focus of the Inspections of the U.S. FDA

In May 2021, the U.S. FDA issued a Warning Letter to a Turkish over-the-counter (OTC) drug manufacturer called "Gulsah Uretim Kozmetik Sanayi Anonim Sirketi" due to significant violations of cGMP regulations for drug products.

01.09.21

FDA sends Warning Letter to Australian OTC Drug Products Manufacturer

The United States Food and Drug Administration (FDA) has recently published a Warning Letter sent to an Australian manufacturer of over-the-counter (OTC) drug products. The Warning Letter summarizes significant violations of current good manufacturing practice (CGMP) concerning finished drug product testing, identity testing of active pharmaceutical ingredients (APIs), and stability testing.

25.08.21

FDA Publishes New Near Infrared (NIR) Guidance

Near infrared (NIR) analytical procedures are widely used in the pharmaceutical industry for identification testing and assay measurements and for monitoring and controlling manufacturing processes. In this context, the U.S. Food and Drug Administration (FDA) has published a new Guidance for Industry entitled Development and Submission of Near Infrared Analytical Procedures.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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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