GMP News - APIs and Excipients

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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28.09.22

EMA: New Update of the "IRIS" Documents

In September 2022, the documents "IRIS guide for applicants" and "IRIS guide to registration and RPIs" were updated again - now containing some innovations and revisions.

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21.09.22

Examples of Analytical Method Implementation

Following the recently introduced new Ph. Eur. chapter 5.26 Implementation of pharmacopoeial procedures, the EDQM published some examples to provide users with practical guidance. How can the critical factors potentially affecting the analytical procedure performance be identified?

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21.09.22

USP: Third Instrument Qualification Stimuli published for Comments

As of early September 2022, the Stimuli Document "Analytical Instrument and System (AIS) Qualification: The Qualification Life Cycle Process" has been posted for comments on the USP Pharmacopeial Forum website.

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21.09.22

EMA/CHMP: New Active Substance Guideline? Concept Paper published for Comments

Since the end of July, the "Concept paper on the revision of the guideline on the chemistry of active substances" of the CHMP's (Committee for Medicinal Products for Human Use) Quality Working Party (QWP) is available for public comments. This document aims to clarify the need to revise and update the guideline "Guideline on the chemistry of active substances (EMA/454576/2016)".

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14.09.22

FDA Warning Letter: Lab Data Integrity disregarded

In July 2022, the U.S. FDA issued a Warning Letter to the U.S. American company "Jost Chemical Co." after having inspected its site in January 2022. The Warning Letter mentions the list of cGMP observations for Active Pharmaceutical Ingredients (APIs).

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24.08.22

China GMP: New Annex 13 for IMPs

In May, the Chinese National Medical Products Administration (NMPA) published their new Annex 13 "GMP for Investigational Medicinal Products (IMPs)", which was incorporated into the Chinese GMP guidelines on July 01, 2022.

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18.08.22

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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18.08.22

Nitrosamine Impurities: Extension of the Deadline for the Submission of Variations

EMA's Question and Answer document on nitrosamine impurities is addressed to marketing authorisation holders. This document describes the approach to review the manufacturing processes for chemically-synthesised and biological medicinal products and to do the risk assessments accordingly. Read more about which new deadlines for variations have to be observed and what has changed in the forms.

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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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