GMP News - APIs and Excipients

17.08.22

FDA Warning Letter: No Stability Studies for Reworked Batches

In June 2022, the U.S. FDA issued a Warning Letter (WL) to the Spanish company "Bioiberica, SAU" after having inspected its site in January and February 2022.

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10.08.22

HMPC´s Update on Medical Cannabis

The EMA Committee on Herbal Medicinal Products (HMPC) published the minutes for the HMPC meeting held in May 2022. The Meeting Protocol contains several interesting developments regarding Cannabis. Will it be possible for regulatory submissions to use the well-established medicinal use pathway in the EU?

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10.08.22

New Ph. Eur. Chapter on Implementation of Pharmacopoeial Procedures

Ph. Eur. 11.0 has been published in July 2022. Amongst others, the 11th Edition contains the previously announced new general chapter 5.26. Implementation of Pharmacopoeial Procedures providing a 2-step approach.

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10.08.22

New Edition of the Technical Guide for the Elaboration of Ph. Eur. Monographs

The European Pharmacopoeia Commission published the 8th edition of the Technical Guide for the Elaboration of Monographs. The guide helps when drafting monographs and transferring analytical methods into a compendial procedure. The previous version of the guide dated back to 2015.

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03.08.22

China GMP and Registration of APIs - Q&As

In December 2021, the ECA offered the Live Online Training "China GMP and Registration of APIs". During the Q&A sessions, many interesting questions were posed to the speakers team.

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03.08.22

New Questions and Answers from the EMA regarding Titanium Dioxide in Medicines

Despite being forbidden as food additive titanium dioxide may still be used provisionally in medicinal products. But the EMA appeals to the pharmaceutical companies to seek intensively for alternative excipients and has published a new questions and answers document to provide assistance. Read here what marketing authorisation holders and applicants have to observe when replacing titanium dioxide or developing new formulations for medicinal products with alternative excipients.

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27.07.22

Extended Input Deadline for USP´s new Chapter on Quality Considerations for Cannabis

Following the previously announced elaboration of a new USP chapter <1568> Quality Considerations for Cannabis and Cannabis-derived Products for Clinical Research the input deadline has been extended.

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27.07.22

Swissmedic´s New Website for Herbal Medicinal Products

The Swissmedic website for authorization of herbal medicinal products (HMPs) has been completely revised and updated. It provides information on simplified authorization procedures for HMPs, e.g. for "HMPs with known active substance".

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27.07.22

FDA Warning Letter: Missing Qualification of Contract Labs for Release

In June 2022, the U.S. FDA issued a Warning Letter tto the Dutch company "Fagron Group B.V." after having inspected their US American site "Fagron Inc." in November 2021.

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21.07.22

EDQM: European Pharmacopoeia Version 11 published

The 11th version of the European Pharmacopoeia (Ph.Eur.) is now available. The latest edition includes some updated monographs which will be implemented on 01 January 2023.

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21.07.22

The latest Updates of the EMA's Question and Answer Document on Nitrosamine Contamination

The EMA and CMDh question and answer collection on nitrosamine impurities in APIs and medicinal products is a "living" document that is updated at irregular but short notice intervals. You can find out here which current requirements and changes with regard to nitrosamine impurity limits, risk assessments and reporting obligations are important for marketing authorisation holders.

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20.07.22

FDA Warning Letter: Benzene Contamination in Hand Sanitizer

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a South Korean manufacturer of OTC drug products. During an FDA laboratory testing of a batch of hand sanitizer, the impurity benzene at unacceptable levels was found. After a review of records and other information provided by the manufacturer, the FDA came to the conclusion that the quality assurance within the facility is not functioning in accordance with CGMP requirements.

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13.07.22

What is an FDA-Approved Product?

The FDA posted an article on the ways the FDA is regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food, and cosmetics. How can you know for sure that a product is FDA-approved?

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13.07.22

GMP vs GACP: BfArM Makes some Clarifications

The German BfArM now clarified for medical Cannabis Manufacturers: A valid GMP certificate must be included with the drying step.

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06.07.22

EDQM: List of Reference Standards Updated

Once again, the list of reference standards, which includes more than 3,000 substances, has been revised and the resulting changes and innovations have been listed in the Newsroom of the EDQM website.

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