GMP News - APIs and Excipients

22.09.21

Blog of the MHRA on Transfer of Analytical Methods

In August 2021, the MHRA provided information on its website about GMP requirements and most common deficiencies in the area of "transfer of analytical methods".

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22.09.21

EDQM updates Guidance for Electronic Submission of CEP Applications

In July 2021, the EDQM (European Directorate for the Quality of Medicines & HealthCare) renewed the document "Guidance for electronic submissions for Certificates of Suitability (CEP) applications" and published it on the related website on 01 September 2021.

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08.09.21

ICH publishes Guideline Q13 on Continuous Production

End of July 2022, the ICH (International Council for Harmonisation) published the draft guideline on continuous manufacturing, which had been awaited for two years. In addition to batch definitions, the document describes three different continuous manufacturing approaches and provides guidance on control strategy and approval issues.

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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.

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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.

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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.

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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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18.08.21

Medical Cannabis in Malta

Malta´s Medicines Authority issued a document which provides general guidance on medical cannabis production. According to the agency applications for medical cannabis production must be completed and the licence and EU-GMP certificate must be granted before production activities are carried out.

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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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11.08.21

Nitrosamine Impurities: FDA Rejects the Extension of Deadline for Submission of Risk Assessments

The U.S. Food and Drug Administration has set a narrow window for the submission of risk assessments on nitrosamine impurities for drugs containing chemically synthesised APIs. Read more here about the arguments used by the pharmaceutical industry to request an extension of the deadline and the reasons given by the FDA for rejecting this request.

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28.07.21

FDA Warning Letter: Missing Stability Data of the API

In May 2021, the U.S. FDA issued a Warning Letter to an Indian OTC manufacturer due to significant violations of cGMP regulations for drug products.

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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

BfArM starts Sale of medical Cannabis "Made in Germany"

Finally it´s done: The BfArM has started the state sale of medical cannabis from German cultivation. However, importation remains possible.

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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

Herbal Drugs - What is Well-Established Use?

Herbal medicinal products can be registered via the well established use approach within the EU. But what is needed for the simplified registration and how to demonstrate well established use?

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