GMP News - APIs and Excipients

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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09.03.22

Information Duties and Responsibilities of CEP Holders - the new EDQM Public Document

The EDQM has published a new public document on the relationship between marketing authorisation holders/applicants and CEP holders. Here you can find out which duties and responsibilities a CEP holder has to fulfil towards his clients.

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02.03.22

FDA Warning Letter: Key Aspects of the ICH Q7 Guideline disregarded

In February 2022, the U.S. FDA issued a Warning Letter (WL) to an Indian drug manufacturing site called "Indiana Chem-Port" due to significant violations of cGMP regulations for active pharmaceutical ingredients (APIs).

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24.02.22

ANVISA: Version 2 of the CADIFA Manual for APIs available

The second version of the "CADIFA Manual for Administrative Procedures" of the Brazilian Health Regulatory Agency (Anvisa) was published in June 2021 and needs to be followed for API dossiers.

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23.02.22

How to keep up to date with GMP

How can you stay up to date with the ongoing changes in the GMP world? This question is frequently addressed during ECA courses and conferences. ECA´s weekly GMP Newsletter informs you about all relevant updates in the GxP arena.

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16.02.22

EMA updates Questions and Answers Document

Do active substances for veterinary medicinal products have to fulfil the same GMP requirements for active substances for human medicinal products? This is just one of the new questions in the EMA Q&A document.

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16.02.22

Herbal Drugs: Ph. Eur. Cannabis Monographs and other relevant Topics

EMA´s Herbal Medicinal Products Committee (HMPC) released the minutes for the HMPC meeting held in November 2021. Amongst others, the HMPC noted three new Ph. Eur. Cannabis Monographs for flowers and extracts in the pipeline. Other relevant topics were nitrosamines, GACP revision and elemental impurities in herbal medicinal products.

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09.02.22

CMDh/HMA: Update of the Q&A List on Variations

A new version of the "Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008" was created in December 2021 and published on the HMA (Heads of Medicines Agencies) website.

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09.02.22

Warning Letter: API Testing still in the Focus of the U.S. FDA

In January 2022, the U.S. FDA issued a Warning Letter to an Indian drug manufacturing site called "Aurobindo Pharmaceutical Limited" due to significant violations of cGMP regulations for active pharmaceutical ingredients (APIs).

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09.02.22

Nitrosamine Drug Substance-related Impurities: FDA Recommendations for Minimising Risks through Formulation Design Changes

To prevent the formation of nitrosamines and establish an effective control strategy, it is necessary to consider all possible risks as comprehensively as possible. A communication from the FDA provides information on the risks that can arise from the formulation of the medicinal product and what needs to be considered when formulating a product. 

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26.01.22

Inadequate OOS Investigations lead to FDA Warning Letter

Recently the U.S. Food and Drug Administration (FDA) issued a warning letter due to inadequate investigations into out-of-specification (OOS) test results.

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