GMP News

Nitrosamine contamination: EMA requests risk evaluation for drug products containing chemically synthesised APIs

The EMA has published three further statements on nitrosamine. Find out what marketing authorisation holders of drugs with chemically synthesised APIs ought to do regarding potential nitrosamine contamination.

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Japanese Pharmacopoeia - Draft Chapter of alternative Endotoxin Testing

The Japanese Pharnacopoe has published a new chapter draft of "Bacterial Endotoxins Test and alternative methods using recombinant protein-reagents for endotoxin assay" for comment.

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Version 16 of the Q&As on Safety Features for Track & Trace

The just published Version 16 of the Q&A´s on Safety Features puts a strong focus on Q&As addressing false alerts due to incorrect scanning by end-users.

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Ph. Eur. 2.4.20. Determination of elemental impurities

A complete revision of Ph. Eur. chapter 2.4.20. Determination of elemental impurities has been published in Pharmeuropa.

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Brexit: RPs for Import from the EU

MHRA gives further guidance for a new Responsible Person function, the RPi - Responsible Person (import).

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FDA to introduce Wholesale Distributor Verification Requirements

FDA announced the availability of a final guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product-Compliance Policy".

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New Q&As on Chapter 4 and 5 of the EU-GDP Guidelines

A set of new FAQs has been published on Chapter 4 (Documentation) and Chapter 5 (Operations).

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How to get GMP Certificates, Importation Licenses & Broker Registrations in UK?

The MHRA recently provided details for new licence applications and variations on the agency´s Inspectorate Blog - together with some helpful links.

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From Valsartan to Ranitidine: Nitrosamine Impurities and the Measures taken by the EMA and the EDQM

In June 2018, when it became known that the antihypertensive medicinal product Valsartan contained nitrosamines, no one had any idea how widespread these unwanted side-products were. Read more here to find out what action the EMA and EDQM have taken in the past and in response to the latest cases of nitrosamine contamination.

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Evaluation of the Immunogenicity of Therapeutic Protein Products - FDA Scientists developed a new Tool

For the important assessment of possible immune responses to therapeutic protein drugs, FDA scientists developed a new mathematical tool to calculate the expected risk of producing antibodies against the biological drug.

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FDA publishes Q&A on Internal Standard Responses in Chromatography Bioanalysis

In support of sponsors, applicants and research institutions, the FDA examines in more detail the variability of internal standards in analytics and their consequences. The authority has now published a document entitled "Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers".

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ATMP from Third Countries - New Q&A Paper on Batch Release published

With a new Q&A document, the EMA has provided information on the release of Adavanved Therapy Medicinal Products (ATMP)  imported into the EU by the Qualified Person without batch re-testing.

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FDA criticizes Lack of Compliance with ICH Q7 Guidance

According to the U.S. FDA, the Chinese firm failed to establish an adequate quality system and lacks quality oversight on documentation.

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Track & Trace: EMVO stakeholders call for inspections

Seven months into the operational phase a significant number of manufacturers and supply chain actors have not yet connected to the EU verification system. Now, the EMVO stakeholders encourage the NCAs to undertake inspections on all supply chain actors.

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FDA Guide for Non-clinical Studies of Oncological Therapeutic Radiopharmaceuticals

The FDA has published a final guideline for non-clinical studies of "Oncology Therapeutic Radiopharmaceuticals" to close the gaps in the existing FDA and ICH Guidelines.

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FDA´s Enforcement Report - Recent Recalls

The FDA´s Enforcement Report tracks and displays updates to recalls. The July 2019 listings contain several Class II recalls due to various cGMP deviations and two Class I ratings. One of the Class I ratings resulted from the finding of glass particulates in an injection.

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How to prepare for ANVISA Inspections

Quite a few authorities in the health care sector come for GMP inspections, also to foreign countries. Here you can read what the Brazilian ANVISA will expect.

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EMA website on Permitted Daily Exposure (PDE) limits

The issue of cross-contamination has been addressed by authorities since the publication of the first edition of the EU GMP Guidelines. The EMA has compiled everything essential on health-based exposure limits and PDE limits on their website.

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European GDP Association nominates Director Regulatory Affairs and Communication

The European GDP Association, representing more than 2.000 professionals from across the globe, has nominated Prabjeet Dulai as Director Regulatory Affairs and Communication.

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GDP: The growing Issue of Theft

The british MHRA is currently publishing a series of blog posts discussing the theft of medicines and the risk to public health.

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USP revises Storage and Transport Chapters

The United States Pharmacopeia (USP) is currently introducing various chapters and stimuli articles. Some of these are also relevant for storage and transport activities.

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EDQM updates two Guidelines on the CEP procedure

The updating of two important documents by the EDQM reflects the current practice of the CEP procedure. Read more about the competencies and responsibilities of the various bodies in the CEP application procedure and about the code of practice for assessors and inspectors.

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Another FDA Warning Letter due to Deficiencies in the Water System

Again the US-American FDA has issued a Warning Letter which primarily describes defects in the water system as well as deficiencies in the handling of CAPA & OOS and in the cleaning.

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Official Danish Cannabis-Monograph

Denmark has published its official pharmacopoeial monograph for Cannabis: Cannabisblomst (Cannabis flos).

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New FDA guidance on Child-Resistant Packaging

The FDA published a new guidance on Child-Resistant Packaging (CRP). The guidance is intended to assist applicants, manufacturers, packagers, and distributors who include CRP statements in their drug product labeling.

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