GMP News

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2nd Version of the USP Draft Guidance on mRNA-based Therapeutics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 The USP has now defined standards and is seeking input during the comment period on a new draft guidance version for the analysis of mRNA.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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Generally Accepted Scientific Knowledge in Drug Applications

The FDA has received an increasing number of questions regarding the extent to which generally accepted scientific knowledge (GASK) may be relied on for drug or biological product approval. Therefore, the agency published a draft guidance which describes instances in which it may be appropriate to rely on GASK to meet certain nonclinical safety requirements for new drug applications.

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FDA's Guidance for Decentralized Clinical Trials

The FDA published a draft guidance on decentralized clinical trials (DCTs). Examples of decentralized elements include obtaining laboratory tests at a local facility rather than a research medical center or conducting a clinical follow-up visit in the trial participant's home.

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EMA starts Review of Transparency Rules for the CTIS

The European Medicines Agency had launched a public consultation on the revision of the transparency rules of the Clinical Trials Information System (CTIS). Stakeholders were invited to send their comments via an online form by end of June 2023.

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How to create a Notified Body compliant Technical Documentation?

One of the most important documents in the context of medical device regulation is the technical documentation. Updated as version 2, a helpful position paper from the Team Notified Body provides assistance in this regard as a best practice guide.

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Dealing with Artificial Intelligence in the Context of the further Development of Software in Medical Devices

The topic of artificial intelligence/machine learning (AI/ML) is currently all around. The FDA has also taken up AI/ML and published various draft guidance documents. A current draft is aimed at manufacturers of medical devices that contain software.

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Northern Ireland: EU Regulation with specific Rules published

An EU Regulation laying down specific rules for medicinal products for human use for Northern Ireland has been published in the Official Journal of the EU. It mainly concerns importation into NI and safety features.

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New VDI Guideline 6022, Blatt 1.1 published as Draft

In June, the VDI published the new guideline 6022 Blatt 1.1 as a draft for comment. The new document is intended to expand on the existing Guideline 6022 Blatt 1, which describes the overall hygiene assessment of ventilation and air-conditioning systems.

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EMA Update on GACP Revision

The European Medicines Agency (EMA) has published on its website the detailed minutes of the Herbal Medicinal Products Committee (HMPC) meeting from 13-15 March 2023. In the meeting, the HMPC discussed some issues known to cause difficulties in procedures and ideally to be addressed during the current GACP revision.

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Updated Public Statement of the HMPC on HMPs containing Estragole

In 2005, the HMPC prepared the "Public statement on the use of herbal medicinal products containing estragole". Now, several footnotes were added in Table 1 of the document regarding the provided examples of estragole-containing plants.

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New Edition of the Herbal Guide

The EDQM has published a new edition of the Guide for the elaboration of monographs on herbal drugs and herbal drug preparations. The Guide provides general guidance on the structure of Ph. Eur. monographs of herbal drugs and herbal drug preparations and on the information to be included in them. In addition, principles for the preparation and revision of herbal monographs are explained.

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Cannabis Reference Standards DAB

The amended German Pharmacopoeia (Deutsches Arzneibuch, DAB) is valid from 1 August 2023. The DAB 2023 now includes several revised texts for Cannabis reagents.

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Abbreviations in the GDP Environment

During GDP events organised by the ECA, the wish came up to compile a list of relevant abbreviations used in the GDP environment. We have prepared such an overview.

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GDP in the US: Update of the USP <1079> Series of Chapters on Good Storage and Distribution Practices

The United States Pharmacopeia (USP) intends to revise several chapters of the <1079> series in response to the omission of General Chapter <1118> Monitoring Devices—Time, Temperature, and Humidity.

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Questions and Answers from the ECA Webinar "GDP Update 2023" - Part 3

More than 60 participants attended the ECA Webinar "GDP Update 2023" in March. Many interesting aspects were discussed in the Q&A session. In total, about 20 questions were addressed to the speaker, Dr. Christian Grote-Westrick, which he answered in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 3 here.

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