GMP News - APIs and Excipients

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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10.08.22

New Edition of the Technical Guide for the Elaboration of Ph. Eur. Monographs

The European Pharmacopoeia Commission published the 8th edition of the Technical Guide for the Elaboration of Monographs. The guide helps when drafting monographs and transferring analytical methods into a compendial procedure. The previous version of the guide dated back to 2015.

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03.08.22

New Questions and Answers from the EMA regarding Titanium Dioxide in Medicines

Despite being forbidden as food additive titanium dioxide may still be used provisionally in medicinal products. But the EMA appeals to the pharmaceutical companies to seek intensively for alternative excipients and has published a new questions and answers document to provide assistance. Read here what marketing authorisation holders and applicants have to observe when replacing titanium dioxide or developing new formulations for medicinal products with alternative excipients.

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27.07.22

Extended Input Deadline for USP´s new Chapter on Quality Considerations for Cannabis

Following the previously announced elaboration of a new USP chapter <1568> Quality Considerations for Cannabis and Cannabis-derived Products for Clinical Research the input deadline has been extended.

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27.07.22

Swissmedic´s New Website for Herbal Medicinal Products

The Swissmedic website for authorization of herbal medicinal products (HMPs) has been completely revised and updated. It provides information on simplified authorization procedures for HMPs, e.g. for "HMPs with known active substance".

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27.07.22

FDA Warning Letter: Missing Qualification of Contract Labs for Release

In June 2022, the U.S. FDA issued a Warning Letter tto the Dutch company "Fagron Group B.V." after having inspected their US American site "Fagron Inc." in November 2021.

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