GMP News - APIs and Excipients

23.11.22

How does the MHRA approve Manufacturing Authorizations for Cannabis Products?

An increasing number of companies with no previous GMP experience are entering the pharmaceutical sector to cultivate, process and manufacture medical cannabis products. Therefore, the MHRA recently posted how the required licences are granted by the agency.

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23.11.22

FDA Warning Letter to Drug Manufacturer in Puerto Rico

Just recently, we reported on a Warning Letter to an American manufacturer of hand sanitizer drug products. Now another Warning Letter has been published by the U.S. Food and Drug Administration (FDA), also addressed to such products. In this case, it is about a drug manufacturer located in Puerto Rico. In addition to formal GMP violations and inadequate analytical testing, the FDA also criticizes the overall condition of the production facility.

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17.11.22

CEP Report of the EDQM

In October 2022, the EDQM has again prepared its "CERTIFICATION MONTHLY REPORT" on the topic of "CEPs" and has published it in the newsroom of the EDQM website.

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16.11.22

FDA Warning Letter again Highlights the Importance of Analytical Testing for Hand Sanitizers Manufacturers

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a U.S. manufacturer. Therein, the FDA once again highlights the importance of analytical testing of incoming raw materials, finished drug product testing and stability testing. In the case in question, a manufacturer of OTC drug products had been found to have significant deficiencies in these areas.

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16.11.22

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

The latest version (version 16) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for active pharmaceutical ingredients was finalised in July 2022 and published on the new APIC (Active Pharmaceutical Ingredients Committee) website at the end of October. The document further on aims to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on how to interpret it.

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15.11.22

FDA sends Warning Letters to Amazon and Walmart

The U.S. Food and Drug Administration (FDA) has issued Warning Letters to Amazon and Walmart. Laboratory analyses showed that both companies sold products that contained diclofenac, which was not listed on the product labels. The FDA sees this as a potential health risk for consumers.

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08.11.22

Final FDA Guidance on Comparability Protocols

The FDA released the final guidance on Comparability Protocols for postapproval CMC changes. The revised guidance follows the draft version issued in April 2016.

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02.11.22

FDA Warning Letter for Chinese OTC Hand Sanitizer Drug Products Manufacturer

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Chinese manufacturer. The FDA blames the company in question for a whole series of GMP violations, including to identity testing, cleaning and maintenance of equipment, microbial testing and QU oversight.

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26.10.22

Nitrosamine Impurities: Further Update of EMA's Question and Answer Document

EMA's Q&A document has recently been updated and extended. Read more here about the current limits for nitrosamines and how to proceed in case of new types of nitrosamine impurities.

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19.10.22

EDQM issues monthly CEP Report

Also in September 2022, the EDQM has prepared its "CERTIFICATION MONTHLY REPORT" on the topic of "CEPs" (Certificate of Suitability of Monographs of the European Pharmacopoeia) and has now published it in the EDQM website newsroom.

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13.10.22

Shortages and Crisis Preparedness: EMA Publishes List of the Main Therapeutic Groups of Medicinal Products

The EMA has published a list of the main therapeutic groups in order to avoid shortages of medicinal products in the case of a public health emergency and thus to ensure the supply of critical medicinal products. Another EMA document defines the methodology for establishing and maintaining this list and further lists of critical medicinal products.

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12.10.22

USP: Stimuli Article on Mutagenic Impurities published for Comments

Since the beginning of September 2022, the stimuli document "Mutagenic Impurities and Potentially Mutagenic Impurities in the USP-NF" has been published for comments on the USP Pharmacopeial Forum website. Comments and observations on this draft can be submitted until 30 November 2022.

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05.10.22

Ph. Eur. Cannabis Monograph Proposed for Comment

The European Pharmacopoeia (Ph. Eur.) published the long-awaited draft of the Cannabis flower monograph in Pharmeuropa with a comment period until 31 December 2022. Once finalized and adopted it is expected that the Ph. Eur. monograph will replace the currently existing national monographs.

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28.09.22

Revised Ph. Eur. Chapter on Foreign Matter

The final version of Ph. Eur. 2.8.2 Foreign Matter in herbal drugs has been published in Ph. Eur. 11.1. The revised chapter clarifies that the quantitative limits for foreign matter only apply to foreign organs and foreign elements; other foreign elements should, as far as possible, be absent.

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28.09.22

USP publishes proposed Cannabis Monograph

A proposed monograph for Cannabis Species Inflorescence has been published in the USP Herbal Medicines Compendium (HMC). It is open for public comments for 90 days.

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