GMP News

APIC: Best Practices Guide for dealing with Suppliers

The "Best practices guide for managing suppliers of API manufacturers" was finalised by the "APIC Supplier Management Task Force" in March 2024 and is now available on the APIC website. It emerged from the document "Supplier Qualification and Management Guideline", which was first published in 2009, and now replaces it in its entirety.

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FDA's current Thinking on KPIs and Quality Metrics

The FDA's current approach to monitoring pharmaceutical manufacturing emphasises the importance of quality metrics in ensuring product safety and efficacy. What is behind this?

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US FDA: Draft on Data Integrity for BE/BA Studies published

At the beginning of April 2024, the draft document "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies" was published on the US FDA website and is now available for comment for 60 days. The document is intended to assist applicants and marketing authorisation holders in the area of data integrity for the clinical and bioanalytical part of bioequivalence and bioavailability studies.

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HTS/NGS - Draft Ph.Eur. Chapter "High-Throughput Sequencing for detecting Viral Extraneous Agents"

In Pharma Europe, the publication of a draft of the new chapter "2.6.41 High-throughput sequencing for the detection of viral extraneous agents" represents a step forward in two important areas. Firstly, with regard to the viral safety of medicinal products and secondly, with regard to the regulatory establishment of modern detection methods.

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Warning Letter to Chinese OTC Manufacturer: Violations concerning Identity Testing, Stability Program and Quality Unit

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a Chinese manufacturer of over-the-counter (OTC) drug products. The violations were identified during the FDA's review of records submitted by the company in response to an official request.

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German Federal Council approves Cannabis Law

The German federal states have cleared the way for the legalization of cannabis. The law came into force as planned on 1 April. What will change for medical Cannabis?

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Inadequate Equipment and Facility Design

A sterile manufacturer in Jordan received a Warning Letter from the US FDA for inadequate equipment and facility design as well as other deficiencies.

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EDQM: Updated Information on the Quality Overall Summary (Module 2)

The revision 1 of the document "Quality overall summary (QOS) template for CEP applications", which was updated in January, has been published on the EDQM website. The document was first published in 2015 and is intended to provide assistance for CEP applicants.

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Indian Sterile Facility in a Dilapidated Condition

During an inspection carried out in October 2022, the FDA found unsanitary and dirty conditions at a sterile manufacturer in India, resulting in a Warning Letter.

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APIC Quality Agreement Guideline: Update published

The first version of the document "Quality Agreement Guideline & Template" was published in 2009, updated in 2017 and has now been revised again. Version 3 of the guideline was published in January 2024 and is now available on the APIC website in the "Publications" tab.

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EU Non-Compliance Report issued after insufficient CAPA

A recent EU Statement of Non-Compliance with GMP contains significant observations and requires the inspected company to carry out a detailed analysis, particularly with regard to CAPA.

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Court Ruling: Suspended Sentence and Heavy Fine for Falsifying Stability Data

A court in the UK has sentenced a pharmaceutical company and its former director to heavy fines. The defendant had admitted to knowingly submitting falsified stability data to the MHRA in order to obtain a Marketing Authorization for a product. This was preceded by years of investigation by the authority.

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FDA Warning Letter to Drug Manufacturing Facility in Thailand

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Thailand. The violations include failure to conduct appropriate laboratory testing for identity and strength of active ingredients prior to release and distribution.

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EMA/CMDh: Appendix 1 for Nitrosamines Updated Again

The nitrosamine Q&A document "Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products" of the EMA/CMDh contains three annexes (Appendix 1-3) in its current version of October 2023. In February 2024, Appendix 1 was updated again and fifteen new substances were added.

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Air-Tightness of Cleanrooms & Containment Solutions: VDI 2083 Part 19 Updated

The question of how tight the cleanrooms must be needs to be answered as early as the planning phase of a facility. The DIN EN 15727 standard and the new version of VDI Guideline VDI 2083 Sheet 19 provide assistance. Read more here.

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New USP Chapter on Cured Silicone Components

The final text for USP <383> Cured Silicone Elastomers for Pharmaceutical Packaging and Manufacturing Components has been published in the USP. The chapter will become official on 1 December 2027. Early adoption of the requirements in this chapter is permitted by USP.

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EMA/FDA joint Q&As on Quality and GMP aspects of Breakthrough Therapy Applications

The FDA and the European Medicines Agency (EMA) published "EMA–FDA joint Q&As on Quality and GMP aspects" supporting quality development for FDA’s Breakthrough Therapy (BT) and EMA's Priority Medicines (PRIME) programs.

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Where to find GDP Certificates and Wholesale Distributor Authorisations

The wholesale distribution of medicinal products requires a Wholesale Distribution Authorisation (WDA). But where actually to find reliable information on whether a particular company is in possession of such an authorisation or GDP certificate? Depending on the location of the company in question, certain databases are available for searching.

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Checklist for Implementation of GDP Principles - Part 5: Operations

According to Chapter 5 of the EU GDP Guidelines, all actions taken by wholesale distributors should ensure that the identity of the medicinal product is not lost and that the wholesale distribution of medicinal products is performed according to the information on the outer packaging. The wholesale distributor should use all means available to minimise the risk of falsified medicinal products entering the legal supply chain. In this article, you will find a checklist to verify the minimum implementation.

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Improving Registration and Reporting Summary Results Information for Clinical Trials

The FDA is announcing a newly published report on the Clinical Trials Transformation Initiative (CTTI) prepared on the findings of a collaborative project with FDA to understand the barriers to timely, accurate and complete registration and reporting of summary results information for clinical trials. According to the report, the major challenge was a lack of understanding on the part of the Responsible Party regarding the types of trials that must be registered, when the trial should be registered and when and for which trials summary results information must be submitted.

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Master Protocols for Drug and Biological Product Development

A new FDA guidance provides recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on the submission of documentation to support regulatory review. Commenting on the proposed guideline was open until 22 February 2024.

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Swissmedic publishes Technical Interpretation on Shipment under Quarantine

Swissmedic, the Swiss national authorisation and supervisory authority for drugs and medical products, has published a new document on "Shipment under Quarantine". It clarifies some situations in which a shipment under quarantine of active substances, intermediate drug products and finished drug products would be acceptable to inspectors.

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APIs in Brazil: how to register and obtain the GMP certificate

In February 2024, the ECA offered the Live Online Training "How to register APIs in Brazil - Focus on CADIFA and obtaining a Brazilian GMP certificate". During the Q&A sessions, many interesting questions were posed to the speakers' team. A list of useful abbreviations and definitions in regard on the Brazilian registration system are collected and provided in the following.

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EDQM: Top Ten Deficiencies for CEPs

In February 2024, the EDQM has published its summary of the top ten deficiencies which occurred during the evaluations of the CEPs in 2023. This document called "TOP TEN DEFICIENCIES in New Applications for Certificates of Suitability for chemical purity" should help applicants to avoid such deficiencies in future and lists in detail the findings and its respective sections.

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FDA publishes Q2(R2) and Q14 Guidelines

After the ICH and the EMA had already made the documents available for download in December and January respectively, the FDA has now announced the availability of the final guidances for the industry entitled "Q2(R2) Validation of Analytical Procedures" and "Q14 Analytical Procedure Development."

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