GMP News - APIs and Excipients

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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30.03.22

France Legalizes Medical Cannabis Cultivation

France is moving forward regarding medical cannabis cultivation and production. As of March 1, it is legal to cultivate cannabis for medical purposes in France.

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23.03.22

EDQM: CEP Application Templates redesigned

Due to the introduction of new IT systems, the EDQM has now also adapted the forms for applying for new CEPs, changes to CEPs and so-called "sister files" and plans to implement them on 01 April 2022.

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23.03.22

German Pharmacopoeia Drafts for Cannabis Reference Substances

The Expert Committee for Pharmaceutical Biology has recommended drafts for revised cannabis reagent descriptions for inclusion in the German Pharmacopoeia (DAB).

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17.03.22

GDP for Active Substances used as Starting Materials in Veterinary Medicinal Products: Obligation to Perform Audits

The European Medicines Agency (EMA) has updated its list of questions and answers on the GMP/GDP guidelines. The newly added chapter deals with the requirements for active substances used as starting materials in veterinary medicinal products. Among other things, it is clarified that the Veterinary Medicines Regulation requires manufacturers and importers of veterinary medicinal products to perform audits based on a risk-assessment on the manufacturers, distributors and importers from whom they source the active substances.

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16.03.22

Will there be an EU Herbal Monograph for Cannabis?

EMA´s HMPC announced the start of several activities relating to regulatory requirements and standards for medical cannabis. Amongst others, the HMPC will establish some basic information regarding existing standard requirements for herbal medicinal products (HMPs).

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16.03.22

Update on Quality Topics for Herbal Drugs

EMA´s HMPC published the HMPC Work plan for 2022. Amongst others, the HMPC plans to establish a Guidance on New Manufacturing Techniques addressing, for example, supercritical CO2-extracts.

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09.03.22

USP: Second Stimuli Article on Instrument Qualification published for Comments

In the beginning of March 2022, the stimuli document "Measurement Uncertainty Evaluation Relevant to Analytical Instrument and System (AIS) Qualification - The Role of Measurement Uncertainty Concepts within the AIS - PF 48(2)" has been published on the USP Pharmacopeial Forum website for comment.

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09.03.22

Herbal Drugs: Concept Paper on GACP Revision Published

EMA´s HMPC published the concept paper on the revision of the guideline on good agricultural and collection practice for starting materials of herbal origin. Amongst others, the revision will address the need for clarification regarding GMP vs GACP.

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