GMP News

GMP for Cannabis - What is required?

More and more countries allow cannabis for medicinal purposes - But what are the regulatory requirements?

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Monographs on Vaccines and Immunosera - Revised Expert Guidance

During its 162th session, the European Pharmacopoeia Commission published the revised guideline "Guide for the elaboration and use of monographs on vaccines and immunosera for human use", which helps experts and interested parties in this field to prepare and interpret the monographs.

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What are FDA's Plans Concerning New (GMP) Guidelines for 2019? The CDER give answers

What are FDA's plans concerning new guidelines for calendar year 2019? The Center for Drug Evaluation and Research (CDER) has provided an answer to that question in its list of planned guidelines and/or guidelines to be revised.

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Process Validation - FDA criticises Missing Lifecycle

In a Warning Letter recently published, the FDA addressed deficiencies regarding process validation. What did the FDA discover?

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Is the Sanitization Temperature for Water Systems too high?

The most common method of preventing microbiological contamination in a water system is thermal sanitisation. There are systems in which the pharmaceutical water is stored hot and systems that are heated cyclically to an elevated, germicidal temperature. However, excessive temperatures not only increase costs, they can also damage the materials. Read more here.

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Does Purified Water (PW) have to be tested for Endotoxins?

Within the framework of risk analysis, qualification and preparation of sampling plans for new purified water (PW) systems, the question arises as to whether PW should be tested for endotoxins. Read more here.

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US FDA Warning Letters for inadequate Batch Records

The U.S. FDA posted new Warning Letters to pharmaceutical companies which ignored basic GMP principles.

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Brexit: GDP Updates for Import Activities and Air Freight

MHRA has published new Guidance for import and air freight activities. One is introducing a new function, the Responsible Person (import) - RPi.

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Hard Brexit: Liability Risk for Carriers

In the case of a "Hard Brexit", delays in import and export are to be expected. This will affect contracts and liability.

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Delivery of not ordered goods - what to do?

A wholesaler receives a delivery of a medicinal product. However, the order was not placed. What should be done?

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FDA´s Pilot Program for Established Conditions

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced a new pilot program where sponsors can propose established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA) or as a prior approval supplement (PAS).

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Is the review of the Audit Trail required in Clinical trials?

The MHRA recently provided guidance on Data Integrity in clinical trials. Is the review of the audit trail required?

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Short Format Development Safety Update Report

Not all trials are the same in terms of risk. Therefore, the MHRA proposesd a simpler and shorter form in lieu of a full Development Safety Update Report, giving a significant time saving.

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Focus on Cannabis in INCB´s Report for 2018

The International Narcotics Control Board (INCB) recently published its report for 2018 with a strong focus on cannabis. Read more about Cannabis and cannabinoids for medical, scientific and “recreational” use: risks and benefits.

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Revision of the Swiss Drug Law - an Overview

The revised Swiss HMG came into force on 1 January 2019 - with some interesting GMP/GDP-relevant changes.

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Current Q&A on the MRA EU-FDA

The EMA has published a new Questions and Answers (Q&A) document on the Mutual Recognition Agreement (MRA) between the EU and the FDA. Read more about the impact of the MRA on regulatory submissions and variations.

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Warning Letter: FDA criticises Supplier Qualification

The full programme is part of a recent FDA Warning Letter, which the FDA sent to a manufacturer in the US only in February: Supplier Qualification, contract management, release procedure.

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Audit Trail Review required before Each Batch Release?

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 2: Is the Audit Trail review required by the authorities before each batch release, or is it only recommended?

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EU Commission: How to prepare for a "Hard Brexit"

The European Commission is fostering its support in preparing EU companies for a no deal scenario ("Hard Brexit").

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New FDA Guideline: Quality Aspects for Continuous Manufacturing

In February 2019, the FDA published a new draft guideline that addresses quality aspects of continuous pharmaceutical manufacturing. It covers topics related to development, process validation, marketing authorisation and routine production.

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Switzerland now also uses EudraGMDP

Switzerland has begun to enter information on GMP inspections into the EMA database.

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Is an Identity Test needed for the content of all Containers?

In a recent Warning Letter, FDA is criticising a Chinese company for their inappropriate identity testing.

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WHO Recommends Re-Classification of Cannabis

After the legal situation for medical cannabis in Germany has already changed in 2017, the World Health Organization (WHO) has now proposed a global re-classification of the addictive potential of cannabis.

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Brexit: Handling Pharmacovigilance Data from the UK

How should reports of adverse reactions from the UK be handled after the withdrawal date? New Q&As give a clear answer.

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Brexit: EU supports pharmaceutical Companies

In a letter, the EU Commission explains possible exemptions for future batch testing in the UK.

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