GMP News

CDER published Q&A Catalogue for Generic Drug Authorisations

In September 2021, the CDER (Center for Drug Evaluation and Research) of the U.S. FDA published a so-called "Draft Guidance for Industry" for generic medicinal product authorisations in the form of a question and answer catalogue.

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EMA: Update of the Q&A Documents "Centralised Procedures"

In July and September 2021, the European Medicines Agency (EMA) published the updated and revised versions of the "Questions & Answers (Q&A)" documents on centralised procedures on their website.

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Updated Version of the Q&As regarding the Clinical Trials Regulation

The European Commission published a revised Version 4 of the Questions & Answers relating to the Clinical Trials Regulation. In particular, updates to Q&As in Chapter 11 "Arrangements for the transitional period" have been made.

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New JP Draft 2.28 Circular Dichroism Spectroscopy Published for Public Comments

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published a Japanese Pharmacopoeia (JP) draft of a New General Test 2.28 Circular Dichroism Spectroscopy. Comments can be submitted until September 30, 2021.

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Serialization: Aide-Memoire for Pharmacies

The previously published Aide-Memoires for GDP and GMP Inspections regarding safety features are now accompanied by a third one: Aide-Memoire for Pharmacy Inspections. What are the obligations of persons authorized or entitled to supply medicinal products to the public?

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Counterfeit Protection - Amendment of Delegated Regulation (EU) 2016/161

Delegated Regulation (EU) 2016/161 is adapted with regard to Article 47 (Evaluation of notifications by national competent authorities to the Commission) and Annex I (List of medicinal products that shall not bear the safety features).

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New FDA Q&As on Endotoxin Testing

As part of its Q&A series, the FDA has published a draft guidance on various quality topics, including questions on endotoxin testing.

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MHRA Guidance for the Supply of Medical Cannabis Products

The MHRA published an updated Guidance on manufacturing, importing, distributing and supplying of cannabis-based products for medicinal use. Amongst others, the MHRA will require a valid GMP certificate for the site of manufacture.

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Four JP Drafts Related to Chromatography Published for Public Comments

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published four Japanese Pharmacopoeia (JP) drafts of General Tests and General Information related to Chromatography. Comments can be submitted until November 30, 2021.

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New General Ph. Eur. Chapter 2.1.7 Balances for Analytical Purposes

In the European Pharmacopoeia (Ph. Eur.) Supplement 10.6, published in July 2021, a new general chapter 2.1.7 Balances for Analytical Purposes was included. It complements existing guidelines for the use and qualification of balances published elsewhere.

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Record Number of Fake Drugs seized during INTERPOL Operation

During an action week coordinated by INTERPOL against illegal internet trade checks led to the discovery of very large numbers of fake and illicit drugs. Overall the operation resulted in the seizure of around 9 million medical devices and illicit pharmaceuticals.

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Revised IPEC GDP Audit Guide for Pharmaceutical Excipients

The International Pharmaceutical Excipients Council Federation (IPEC Federation) announced the availability of the revised IPEC Good Distribution Practices Audit Guide for Pharmaceutical Excipients.

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Absence of Approved Storage Facilities leads to GDP Non-Compliance Report

The competent authority of Czechia has added a new GPD Non-Compliance Report into the EudraGMDP database. The report states that the company concerned does not provide approved storage facilities and the services of a qualified person are not ensured.

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Who does issue a GDP Certificate?

During various ECA training courses, the question came up who actually issues a GDP certificate and which companies can obtain such a document.

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Blog of the MHRA on Transfer of Analytical Methods

In August 2021, the MHRA provided information on its website about GMP requirements and most common deficiencies in the area of "transfer of analytical methods".

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EDQM updates Guidance for Electronic Submission of CEP Applications

In July 2021, the EDQM (European Directorate for the Quality of Medicines & HealthCare) renewed the document "Guidance for electronic submissions for Certificates of Suitability (CEP) applications" and published it on the related website on 01 September 2021.

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FDA´s final Q&As on Field Alert Reports

The FDA recently finalized the guidance on expectations for submitting Field Alert Reports (FARs) for potentially defective drugs. The final document supersedes a draft guidance that was issued in July 2018.

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New FDA Draft Guidance for Industry on Bioequivalence Studies

The FDA has published a draft guidance for industry entitled “Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.” The document provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. The FDA recommends that in vivo BE studies are accompanied by in vitro dissolution profiles. Under certain circumstances, BE can be evaluated alone by using in vitro approaches (e.g., dissolution testing).

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Consultation on Amendments on Pharmacovigilance Activities

A targeted stakeholder consultation on amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities has been published on the EC website. The Regulation outlines the practical details on the performance of pharmacovigilance activities to be respected by MAHs, national competent authorities and the EMA.

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Signal Management: EMA and EC agree to further extend the Pilot

The EMA and the European Commission have agreed to further extend the pilot on signal detection in EudraVigilance by marketing authorization holders until the end of 2022. MAHs with APIs included in the EMA list of active substances and combinations involved in the pilot should continue to monitor them in EudraVigilance.

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EMA supports use of global Track & Trace Systems

The EMA supports recommendations for the use of global track & trace systems to mitigate the risk of drug shortages and fight against falsified medicines. To date, track & trace systems have been designed and implemented with a local or regional focus, without taking into account whether they can exchange information with other systems.

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Industry still facing Problems with Root Cause Investigations

Deviations and CAPA are still important issues during inspections. Inspectors' summaries of their observations show that things do not always work as they should. This also applies to root cause investigations.

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USP with new Chapter on Supplier Qualification and Guidance for associated Risk Assessments

Even though the USP has no direct force of law, certainly not in Europe, interesting points for use in risk-based supplier qualification programmes can be found in a newly proposed USP chapter.

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FDA Warning Letter on Significant Data Integrity Issues at Chinese Manufacturer

Data integrity issues continue to be a focus of FDA inspections. Significant problems with data proving the safety, efficacy and quality of manufactured medicinal products were among the reasons for the Warning Letter to the Chinese company BBC Group Limited.

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EMA Update of the Q&As on Herbal Medicinal Products

The updated EMA document "Regulatory Q&A on herbal medicinal products" contains several revised Q&As including the Q&As regarding the requirements for the simplified registration procedure.

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