GMP News - APIs and Excipients

25.05.22

New Version of the ICH Q3D Guideline for Impurities published

Since the end of April 2022, the second revision of the ICH "Guideline for Elemental Impurities Q3D(R2)" is available on the ICH website under the heading "Quality Guidelines". This version includes revisions and adaptations in Appendices 2 and 3. Appendix 5 has been newly added.

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25.05.22

FDA Warning Letter: Deviation from USP Compendial Methods

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an American manufacturer. The firm produces a United States Pharmacopeia (USP) article. The core problem was that the company deviated from the USP for analytical testing, but could not adequately demonstrate that the method is equivalent or better than the current USP compendial method.

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18.05.22

FDA Warning Letters for Products Containing CBD and Delta-8 THC

The FDA issued several Warning Letters to companies for illegally selling CBD products and products labeled as containing delta-8 THC. Violations include the marketing of unapproved new drugs, misbranding, and adding delta-8 THC to food products.

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18.05.22

Elastomers for Pharmaceutical Packaging and Manufacturing

Following the recently adopted USP general chapter <665> for plastic materials used in manufacturing, the USP now published two draft chapters for elastomers for pharmaceutical packaging and manufacturing.

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11.05.22

How to Demonstrate Comparability of Analytical Procedures

A new Ph. Eur. Chapter 5.27. Comparability of alternative analytical procedures has been proposed in Pharmeuropa 34.2. The comment deadline is 30 June 2022.

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05.05.22

Update of the EMA Q&As on parallel Distribution of Medicinal Products

The so-called "Frequently asked questions about parallel distribution" for centrally authorised medicinal products were updated in April 2022 and published on the EMA website.

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05.05.22

EDQM updates List of available Reference Standards

Also in March, the list of available reference standards, which comprises more than 3.000 substances, was revised - and the resulting changes, innovations and updates were listed in the newsroom of the EDQM website.

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05.05.22

FDA publishes updated PQ/CMC Document for Comments

In March, the U.S. FDA published the draft of the "Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange document" for comments.

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04.05.22

EMA´s Cannabis Glossary

The glossary summarizes existing scientific and legislative terminology relevant for medicinal products containing Cannabis-derived active substances. What is CBD oil and what is Cannabis oil?

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13.04.22

Japanese Pharmacopoeia 18th Edition - English Version Now Available

The English translation of the Japanese Pharmacopoeia (JP) 18th edition is available for download free of charge.

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13.04.22

Still Issues with CBD Products

The FDA issued again Warning Letters to several companies for selling Cannabidiol (CBD) products with misleading product claims.

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06.04.22

Manufacturer of "Magic Heal" Receives FDA Warning Letter

In March 2022, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to an American over-the-counter (OTC) drug product manufacturer due to significant violations of Current Good Manufacturing Practice (CGMP). The violations were related to identity testing, training, calibration, qualification and quality unit oversight.

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05.04.22

EDQM: Availability of Reference Standards

The EDQM (European Directorate for the Quality of Medicines & HealthCare) regularly updates the list of available reference standards on its website.

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05.04.22

EDQM implements "Real-Time Remote Inspections"

Due to the Corona pandemic and the resulting changes in working conditions, a new type of inspection was needed in addition to classical on site inspections of API manufacturing facilities and paper-based GMP assessments. For this purpose, the pilot project for so-called "Real-Time Remote Inspections (RTEMIS)" was created.

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30.03.22

USP collects Data for global Medicine Supply Map

The U.S. Pharmacopeia (USP) operates a so-called global Medicine Supply Map as an early warning system to counteract risks of drug shortages.

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