GMP News

New Proposal for USP Chapter <711> Dissolution Published for Comments

In the Pharmacopeial Forum, PF 48(6), a proposal for a revised Chapter <711> Dissolution was published. The purpose of the revision is to replace USP Prednisone Tablets RS with a new Reference Standard, USP Dissolution Performance Verification Standard-Prednisone RS, to qualify the Dissolution Apparatus 1 and Apparatus 2.

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Warning Letters for Companies selling CBD containing Food and Beverages

The U.S. FDA warns five companies for illegally selling food and beverage products containing cannabidiol (CBD). According to the agency, the use of CBD raises safety concerns, especially with long-term use.

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Revision of the EU GMP Guide Annex 11 "Computerised Systems" - Presentation of Concept Paper

The current EU GMP Annex 11 "Computerised Systems" was published in 2011. Due to new technological and regulatory developments, a forthcoming revision of Annex 11 has been discussed for some time. On 16 November 2022, the EMA published a concept paper for public comment. Which points are to be revised?

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Real-World Data: EMA´s Good Practice Guide

The European Medicines Agency has published for public consultation a Good Practice Guide for the use of the Metadata Catalogue of Real-World-Data Sources. The guide provides recommendations on how to use the real-world metadata catalogue that is currently being built and will help to identify suitable RWD sources.

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FDA launches Real-World Evidence Program

The agency is conducting an Advancing Real-World Evidence Program, which seeks to improve the quality and acceptability of RWE-based approaches in support of new intended labeling claims.

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How does the MHRA approve Manufacturing Authorizations for Cannabis Products?

An increasing number of companies with no previous GMP experience are entering the pharmaceutical sector to cultivate, process and manufacture medical cannabis products. Therefore, the MHRA recently posted how the required licences are granted by the agency.

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Broader Acceptance of GMP Inspection Reports from PIC/S Countries

Some authorities within the PIC/S want to mutually recognise GMP inspection reports in order to avoid duplication of work. There is now a corresponding statement on this.

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Amendment to the CTR on IMP Labelling

The European Commission (EC) amended the current requirements provided in the Clinical Trials Regulation (CTR) for the labelling of investigational medicinal products (IMPs) regarding expiry dates by means of a Delegated Regulation.

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FDA Warning Letter to Drug Manufacturer in Puerto Rico

Just recently, we reported on a Warning Letter to an American manufacturer of hand sanitizer drug products. Now another Warning Letter has been published by the U.S. Food and Drug Administration (FDA), also addressed to such products. In this case, it is about a drug manufacturer located in Puerto Rico. In addition to formal GMP violations and inadequate analytical testing, the FDA also criticizes the overall condition of the production facility.

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Post-approval Changes to Combination Products - FDA Perspective

Now that the ICH Q 12 Guideline on Pharmaceutical Product Life Cycle Management has also been implemented in the US, guidance on the subject is following. In a new guideline "Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA", combination products are also addressed.

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CEP Report of the EDQM

In October 2022, the EDQM has again prepared its "CERTIFICATION MONTHLY REPORT" on the topic of "CEPs" and has published it in the newsroom of the EDQM website.

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EMA: Q&A Documents on Centralised Procedures updated again

The "Questions & Answers (Q&A)" documents relating to centralised marketing authorisation procedures, last revised in June, have now been updated again and published on the European Medicines Agency (EMA) website. These Q&As are intended to provide guidance and guidelines for marketing authorisation holders and applicants of centralised procedures and to provide answers to potential questions at different stages of the centralised marketing authorisation application process.

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MHRA resumes international Inspections

In a blog post, the UK MHRA comments on the resumption of international GMP inspections and the validity of expired GMP certificates.

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FDA Warning Letters of the Fiscal Year 2022: the "Top Ten" GMP Deficiencies

The analysis of the Warning Letters sent out in fiscal year 2022 offers a revealing overview of what FDA inspectors find when they visit the production facilities of medicinal product manufacturers. Read more about the "Top Ten" GMP violations.

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FDA Warning Letter again Highlights the Importance of Analytical Testing for Hand Sanitizers Manufacturers

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a U.S. manufacturer. Therein, the FDA once again highlights the importance of analytical testing of incoming raw materials, finished drug product testing and stability testing. In the case in question, a manufacturer of OTC drug products had been found to have significant deficiencies in these areas.

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APIC: New Update of the ICH Q7 "How to do" Document

The latest version (version 16) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for active pharmaceutical ingredients was finalised in July 2022 and published on the new APIC (Active Pharmaceutical Ingredients Committee) website at the end of October. The document further on aims to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on how to interpret it.

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FDA criticises Root Cause Analysis and CAPA in a Warning Letter

In a Warning Letter to a US manufacturer, the FDA criticises investigations after deviations in the media fill. Also, derived CAPA measures did not go far enough for the FDA.

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FDA sends Warning Letters to Amazon and Walmart

The U.S. Food and Drug Administration (FDA) has issued Warning Letters to Amazon and Walmart. Laboratory analyses showed that both companies sold products that contained diclofenac, which was not listed on the product labels. The FDA sees this as a potential health risk for consumers.

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GDP for Veterinary Medicinal Products: EMA updates Q&A Document

The European Medicines Agency (EMA) has updated the answers to frequently asked questions on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) on its website. The newly inserted section revolves around the requirement relating to the nature of check at the reception of veterinary medicinal products before being transferred to saleable stock.

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GDP Non-Compliance Report for Belgian Wholesale Distributor

End of October 2022, the Competent Authority of Belgium (Federal Agency for Medicines and Health Products) added a new GDP Non-Compliance Report to the EudraGMDP database. The authority blames the company in question for a whole series of GDP violations.

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Temperature Mapping for the Qualification of Storage Areas

In the Pharmacopeial Forum, PF 48(5), a stimuli article entitled "The Use of Temperature Mapping for the Qualification of Storage Areas for the Proper Temperature Storage of Drug Products" was published.

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Cloud Computing: What is the meaning of Iaas / PaaS / SaaS / XaaS?

Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 1: What is the meaning of IaaS / PaaS / SaaS / XaaS?

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Vulnerabilities in global Supply Chains: Reasons and possible Solutions

The EU Commission has published a document on a "Structured Dialogue on the security of medicines supply". This document presents the most important results of the analysis of the security of supply and possible measures.

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EMA publishes ICH M11 (CeSHarP) for Comments

The EMA published the ICH M11 draft Guideline on the Clinical Electronic Structured Harmonized Protocol (CeSHarP) for comments. The comment period runs until February 26, 2023.

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Final FDA Guidance on Comparability Protocols

The FDA released the final guidance on Comparability Protocols for postapproval CMC changes. The revised guidance follows the draft version issued in April 2016.

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