GMP NEWS 2022

Genome Editing in Gene Therapy - FDA Draft Guidance for IND

Gene therapies are becoming increasingly important. One method is the so-called genome editing. The FDA has published a draft guidance for Investigational New Drugs (IND) for these Gene therapy products.

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FDA updates Information on Bacterial Contamination of Platelets for Transfusion

In December, the FDA updated its important information for blood establishments and transfusion services on bacterial contamination of platelets for transfusion, which has been published since 2016.

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Japanese Pharmacopoeia 18th Edition - English Version Now Available

The English translation of the Japanese Pharmacopoeia (JP) 18th edition is available for download free of charge.

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FDA moves on with Quality Metrics Reporting Program

The US Food and Drug Administration (FDA) is trying to revive its somewhat forgotten Quality Metrics Reporting Program. Now the FDA is asking for specific feedback.

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Still Issues with CBD Products

The FDA issued again Warning Letters to several companies for selling Cannabidiol (CBD) products with misleading product claims.

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FDA Form 483 due to Delayed Stability Testing at a Sterile Injectable Manufacturing Site

In March 2022, the U.S. Food and Drug Administration (FDA) sent a Form 483 to Cadila Healthcare’s sterile injectable manufacturing site in Jarod, India. Among other observations, it came out that the stability program is not followed to complete the testing within the predefined time frame. Some tests were even delayed by more than 120 days.

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US Track & Trace Requirements

The FDA has issued a questions and answers document to assist industry and State and local governments in understanding the effects of the Uniform National Policy on drug product tracing.

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Manufacturer of "Magic Heal" Receives FDA Warning Letter

In March 2022, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to an American over-the-counter (OTC) drug product manufacturer due to significant violations of Current Good Manufacturing Practice (CGMP). The violations were related to identity testing, training, calibration, qualification and quality unit oversight.

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Who needs to review Batch Records?

The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to do so? No, because this is not a requirement.

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Process Validation Deficiencies from the FDA's Perspective - Statistics for Fiscal Year 2021

In our News on FDA Warning Letter Statistics for the fiscal year 2021 (October 2020 - September 2021) you could read that deficiencies for process validation are on place 5. But what deficiencies did the FDA find in process validation?

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ICH Guidance Q14 / Q2(R2) - Analytical Method Development/Method Validation Published for Consultation

On March 24, the drafting process of the new ICH Guideline Q14 Analytical Procedure Development and the revised Guideline Q2(R2) Validation of Analytical Procedures reached Step 2, and both were published for consultation by ICH members.

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EDQM: Availability of Reference Standards

The EDQM (European Directorate for the Quality of Medicines & HealthCare) regularly updates the list of available reference standards on its website.

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EDQM implements "Real-Time Remote Inspections"

Due to the Corona pandemic and the resulting changes in working conditions, a new type of inspection was needed in addition to classical on site inspections of API manufacturing facilities and paper-based GMP assessments. For this purpose, the pilot project for so-called "Real-Time Remote Inspections (RTEMIS)" was created.

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MHRA GCP Inspector´s Experience during the COVID-19 Pandemic

The MHRA GCP Inspectors provided insight in their experience during the COVID-19 Pandemic. Although they have their limitations, remote GCP inspections have proven to be very effective and critical findings have been identified.

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Recent Findings in GCP Inspections

The EMA published the Annual report of the Good Clinical Practice Inspectors’ Working Group (GCP IWG) containing examples of findings observed during recent GCP inspections. In addition, the 3-year work plan for the GCP IWG has been released.

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Version 5 of the Q&As regarding the Clinical Trials Regulation

What is the final deadline for submission of a clinical trial according to the former CTD rules? The European Commission published an updated Version 5 of the Questions & Answers relating to the CTR which came into application on 31 January 2022. The revision includes new Q&As regarding arrangements for the transitional period.

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EMA: Update of the "IRIS Guidance Documents"

Both the "IRIS guide to registration and RPIs" and the "IRIS guide for applicants" were updated in February and published on the EMA website.

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Centralised Procedures: Update of the Q&A Document

In March 2022, the European Medicines Agency (EMA) published on its website the updated and revised version of the "Questions & Answers (Q&A)" document "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure" regarding centralised procedures.

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FDA Warning Letters in Fiscal Year 2021: Deficient Stability Tests Reason for most frequent Complaints

During an FDA inspection, the area of quality control is always closely investigated. This is reflected in the citations in the Warning Letters of the past fiscal year. Find out where the most frequent GMP violations occurred and what the FDA inspectors had to complain about with regard to stability tests on active ingredients and finished medicinal products.

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USP collects Data for global Medicine Supply Map

The U.S. Pharmacopeia (USP) operates a so-called global Medicine Supply Map as an early warning system to counteract risks of drug shortages.

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