GMP News - APIs and Excipients

31.03.21

Rapid Revision and Implementation of Pharmacopoeial Monographs Concerning 5 Sartan Preparations

In the light of the recommendations made in CHMP's final assessment report on nitrosamine impurities in sartan preparations, the European Pharmacopoeia Commission has revised 2 general chapters and 5 API monographs in a rapid procedure. Read more here about which new requirements are specified in the updated sartan monographs.

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24.03.21

Cannabis Glossary and GACP Revision

EMA´s Committee on Herbal Medicinal Products published the 2021 HMPC Work plan. Amongst others the HMPC plans to establish a Cannabis glossary and to revise the GACP guidelines.

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24.03.21

New THC Threshold for Hemp Products

The German Federal Institute for Risk Assessment has issued a new statement recommending that the assessment of hemp-based food products be based on the EFSA-derived acute reference dose of 1 microgram Δ9-THC/kg body weight.

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17.03.21

FDA stops another Delivery of Hand Sanitizer at the US Border

The U.S. Food and Drug Administration (FDA) has once again stopped a delivery of hand sanitizers with too low alcohol content. The Mexican manufacturer received a Warning Letter.

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17.03.21

Is Medical Cannabis a Medicinal Product?

The Higher Regional Court (OLG) of Hamburg has decided, in the context of proceedings aimed at the issuance of an interim injunction against a wholesaler, that medical cannabis (cannabis flowers) is not (yet) a medicinal product at the wholesale level.

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04.03.21

FDA's Strategies for Bacterial Safety of Platelets

In December, the FDA updated its guidance on bacterial safety strategies for platelets and platelet preparations, particularly in light of the current implementation difficulties faced by facilities under pandemic conditions.

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03.03.21

APIC: Annual Update of the ICH Q7 "How to do" Document

Version 14 of the "How to do" Document - Interpretation of the ICH Q7 Guide and "Review form" for APIs, which has been available since the beginning of the year, mainly includes additions and updates in the chapters 11, 15 and 16. The How to do document is intended to facilitate the implementation of the ICH Q7 Guide and lists recommendations on how to interpret it.

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24.02.21

FDA stops Hand Sanitizers with too low Alcohol Content at the US Border

The U.S. Food and Drug Administration (FDA) pays close attention to what is inside hand sanitizer products imported into the United States. Recently, a product labeled as containing 75% ethanol, but in fact contained only 58%, was detained and refused admission at the border. As a consequence, the Chinese manufacturer received a Warning Letter.

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24.02.21

UK Guidance on Limits for Controlled Cannabinoids in CBD Products

Extracts or isolates containing Cannabidiol are used in cosmetics and food supplements supplied to the UK market. One question still remains: How to interprete the 1 mg UK limit for controlled cannabinoids?

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17.02.21

EMA Clarifies GMP Requirements for Herbal Substances Used as APIs

When does EU GMP Guide Part II apply to the manufacture of herbal extracts? A new EMA Q&A document on GMP for herbal extracts used as active substances in herbal medicinal products gives the answer to this question.

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20.01.21

EMA: Updated Q&A documents on Centralised Procedures

The "Q&A" documents for centralised procedures were revised and published on the EMA website in January. In general, pre- and post-approval advices regarding centralised procedures are given and specially information for applicants of generic or hybrid medicinal products is mentioned. 

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05.01.21

New Approach for Dissolution or Disintegration Tests in Ph. Eur. Monographs to be Published in Supplement 10.6.

A new policy for dissolution and disintegration testing in European Pharmacopoeia (Ph. Eur.) monographs has been adopted at the 168th session of the European Pharmacopoeia Commission (November 2020). A dissolution or disintegration test will be included in each medicinal product monograph on an immediate-release solid dosage form.

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05.01.21

FDA Warning Letter: No Adequate Quality Unit, Laboratory Controls, Sampling Plans, and Stability Program

The U.S. Food and Drug Administration (FDA) recently sent a warning letter to a US over-the-counter (OTC) drug manufacturer due to significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

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09.12.20

UN Commission Reclassifies Cannabis

The United Nations (UN) Commission on Narcotic Drugs (CND) has decided to reclassify cannabis. With this, the Commission followed the WHO recommendation of 2019.

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09.12.20

The Influence of Process Changes on Process Validation

What influence can process changes have on process validation? A current FDA Warning Letter provides information on this.

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