GMP News

Do you know DARWIN?

The EMA has published a document outlining a framework for establishing Real-world evidence (RWE) data in regulatory decision-making, based on the findings of some 30 studies initiated by the EMA and DARWIN EU®.

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EMA: New Update of the Q&A Documents on Centralised Procedures

Once again, the Questions & Answers documents with regard to centralised marketing authorisation procedures have been revised and published on the European Medicines Agency (EMA) website in June 2023. The Q&As, which can be used by marketing authorisation holders and applicants of centralised procedures, provide answers to possible questions at different stages of the centralised marketing authorisation application.

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CEP 2.0: Insights into Inspection Reports

As part of the implementation of the new "CEP 2.0", the EDQM has now published on its website a list of authorities and organizations that have insight into inspection and assessment reports.

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EDQM: Policy for CEP Applications published for Comments

In June, the draft Certification Policy Document PA/PH/CEP(04) 1, 6R "Content of the dossier for CEP applications for chemical purity and microbiological quality of substances for pharmaceutical use" was published on the EDQM website for comments. Comments and remarks on this draft can be submitted until 15 September 2023.

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Ph. Eur. Monographs for Cannabis Flower and CBD adopted

The EDQM recently announced that the final Ph. Eur. Monographs for Cannabis flower and Cannabidiol (CBD) will be published in Ph. Eur. Supplement 11.5 with an implementation date of 1 July 2024. Will it be a step forward to EU harmonization of Quality Requirements?

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Draft Bill on the German Cannabis Act published

The German draft bill on the controlled use of cannabis (German Cannabisgesetz - CanG) is available. Will cannabis now be removed from the German BtMG?

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Ph. Eur. Update on Pharmaceutical Preparations

A revised version of the Ph. Eur. general monograph Pharmaceutical Preparations has been published. In particular a reference to the general Ph. Eur. chapter Contaminant pyrrolizidine alkaloids (2.8.26) has been added.

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COVID-19 Flexibilities also to be terminated in the GMP/GDP Environment

The EU is phasing out the extraordinary regulatory flexibilities for medicines that were put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic. This includes regulatory procedures, manufacturing and importation of APIs and finished products and other requirements.

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EU-GMP: Is remote QP Batch Certification/Confirmation allowed?

The EMA has published new questions and answers on remote batch certification/ confirmation by the Qualified Person (QP). When allowed by the competent authority, clear expectations are defined.

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FDA Warning Letter issued due to no response

In June 2023, the U.S. FDA issued a Warning Letter to the Chinese company "Chengdu KeCheng Fine Chemicals Co., Ltd.". According to the Warning Letter, the company is registered within the USA as an API manufacturing facility, which shipped APIs to the U.S. several times.

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EMA publishes new and updated product-specific Bioequivalence Guidance

The European Medicines Agency (EMA) has published new or updated product-specific guidelines for the demonstration of bioequivalence.

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Auxiliary Packaging Components

The USP adopted the revised general chapter <670> Auxiliary Packaging Components. In particular a new category "odor adsorbent" has been added.

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Recent Postings in the GDP Discussion Forum

The European GDP Association, representing more than 4,300 professionals from across the globe, offers a Discussion Forum free of charge for its members. It gives you the opportunity to address your GDP-related questions to a large audience. Several interesting topics have been discussed over the last few weeks. To get an idea, take a look here.

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GDP in the US: FDA Draft Guidance on Wholesaling under Section 503B of the FD&C Act

The U.S. Food and Drug Administration (FDA) has published a Draft Guidance for Industry entitled "Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act". Comments can be submitted until 28 August 2023.

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Turkish Authority publishes new Guideline on GDP Inspections

The Turkish Medicines and Medical Devices Agency (TITCK) has published a new revision of its guidelines related to inspections regarding the storage and distribution of medicinal products for human use.

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FDA now also assesses Countries and Regions as a Risk Factor

The FDA has updated one of its internal manuals to add a risk factor for facilities in countries where there has been an increase in violations. This is nothing more than a risk factor for a region or an entire country.

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How to determine the Protective Properties of Amber Glass Containers?

Colored glass containers are usually used to contain light-sensitive drug products. A previously issued USP Stimuli Article on the measurement of the protective properties of colored glass containers has now been republished. The article provides proposed maximum allowed specific transmission values for colored glass containers.

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Pharmeuropa: Revised Chapter 2.2.47. "Capillary electrophoresis" published for Comments

In the Pharmeuropa issue 35.3, a proposal for a revised chapter 2.2.47 "Capillary electrophoresis" was published. The deadline for submitting comments is 30 September 2023.

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2nd Version of the USP Draft Guidance on mRNA-based Therapeutics

Because the application of mRNA technology is relatively new, regulatory guidelines and industry standards to govern non-compatible aspects of mRNA quality during development and manufacturing are still evolving. The USP has now defined standards and is seeking input during the comment period on a new draft guidance version for the analysis of mRNA.

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Artificial Intelligence/Machine Learning in the Analysis of Biotherapeutics

The complexity of therapeutic protein-based medicinal products makes characterisation of these products difficult. However, the use of artificial intelligence and machine learning in flow imaging microscopy opens up new possibilities.

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Potential Assays for Monoclonal Antibodies and Other Therapeutic Proteins

The FDA recommends and provides guidance on potency assays for monoclonal antibodies and other therapeutic proteins that directly target viral proteins or host cell proteins that mediate pathogenic mechanisms of infection. The purpose of this FDA guidance is to assist in the development and implementation of such assays to ensure adequate information on efficacy throughout the shelf life of the product.

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Quality Culture in the Pharmaceutical Industry: Benefits and Challenges

The pharmaceutical industry's adoption of Quality Culture is transforming the way organisations approach quality management. Although challenges exist in fostering a culture of quality, the benefits outweigh the obstacles.

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Packaging of Solid Dosage Forms: Warning Letter in the USA

Due to numerous GMP deficiencies, a US company in the field of solid dosage form packaging received a Warning Letter from the FDA. The inspection had already taken place in November 2022. Since the FDA found the company's response to the Form 483 as insufficient, the Warning Letter now followed.

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EMA publishes Comments on ICH M11 CeSHarP

The EMA has updated its ICH M11 website to include overviews of comments received on the M11 draft documents. In particular, a huge number of comments were received from organizations relating to the ICH M11 template.

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Interim Guidance on Protection of Personal Data & Commercially Confidential Information

Following the previously published public consultation document on Data Protection of Information uploaded in the CTIS, the EMA has now published an interim guidance. The document is available for CTIS users and provides guidance on the protection of personal data and commercially confidential information (CCI) while using CTIS.

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