GMP NEWS 2022

Amazon Receives Warning Letter from FDA

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Amazon for selling unapproved drugs for mole and skin tag removal that have not been evaluated by the FDA for safety, effectiveness or quality. Amazon has 15 working days to respond and explain the specific steps that were taken to address the violations. Otherwise, legal action may result.

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FDA draws consequences for poor quality of hand disinfectants and UV Wands

In the follow-up to the pandemic situation, the FDA is still reviewing the manufacture and importation of hand sanitizers and identifying potentially critical hand sanitizers. This is shown by the warning letter issued to Guangzhou Orchard Aromatherapy & Skin Care Co.

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Data Integrity Problems as Main Topic of an FDA Warning Letter

Data integrity is still one of the major topics in FDA inspections. Missing controls to ensure the integrity of electronic data as well as inadequate access controls were some of the reasons why a Warning Letter to American company Vi-Jon was issued.

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Nitrosamine Impurities: Extension of the Deadline for the Submission of Variation Applications

EMA's Question and Answer document on nitrosamine impurities is addressed to marketing authorisation holders. This document describes the approach to review the manufacturing processes for chemically-synthesised and biological medicinal products and to do the risk assessments accordingly. Read more about which new deadlines for variations have to be observed and what has changed in the forms.

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CMC: FDA publishes Guideline with questions on post-approval modification of single-use materials

With the publication of a question and answer guideline, the FDA is responding to the challenges of the shortage of disposable materials in manufacturing and the requirements for the use of alternative materials in the area of chemistry, manufacturing and controls (CMC).

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FDA Warning Letter: No Stability Studies for Reworked Batches

In June 2022, the U.S. FDA issued a Warning Letter (WL) to the Spanish company "Bioiberica, SAU" after having inspected its site in January and February 2022.

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Training and the FDA

The US American CGMP Rules 21 CFR 211 also contain requirements concerning training (21 CFR 211.25). An actual warning letter shows the current interpretation of this requirement by the FDA. How does the FDA interpret the chapter "Training" today?

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CTIS & EudraVigilance - Update for Sponsors of Clinical Trials

The EMA provides guidance for sponsors who have to report SUSARs via EudraVigilance originated in the context of clinical trials. In addition the updated document "Key Information for Sponsors on CTIS" has been published.

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UK changes SUSAR Reporting for IMPs

The eSUSAR website used for the submission of SUSAR reports to the MHRA will be decommissioned at the end of September and only SUSARs via the ICSR Submissions portal will then be accepted.

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FDA offers "Snapshot" Feature for Clinical and Development Guidelines

Documentation is an important element in the world of GMP. This applies to protocols as well as recording documents. For the field of development, the FDA is now offering a pilot program for a new function called "Snapshot" for their clinical and development guidelines. What's behind it?

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GAMP®5 2nd Edition released!

At the end of July 2022, the GAMP organization has published the 2nd Edition of GAMP® 5. What are the main changes and developments compared to the previous version, which has been available since 2008?

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HMPC´s Update on Medical Cannabis

The EMA Committee on Herbal Medicinal Products (HMPC) published the minutes for the HMPC meeting held in May 2022. The Meeting Protocol contains several interesting developments regarding Cannabis. Will it be possible for regulatory submissions to use the well-established medicinal use pathway in the EU?

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New Ph. Eur. Chapter on Implementation of Pharmacopoeial Procedures

Ph. Eur. 11.0 has been published in July 2022. Amongst others, the 11th Edition contains the previously announced new general chapter 5.26. Implementation of Pharmacopoeial Procedures providing a 2-step approach.

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New Edition of the Technical Guide for the Elaboration of Ph. Eur. Monographs

The European Pharmacopoeia Commission published the 8th edition of the Technical Guide for the Elaboration of Monographs. The guide helps when drafting monographs and transferring analytical methods into a compendial procedure. The previous version of the guide dated back to 2015.

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How often do terminal HEPA Filters need to be changed?

A frequently asked question concerns the time after which the terminal filters of the ventilation system in pharmaceutical cleanrooms must be changed.

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Revision of USP Chapter <1094> Capsules - Dissolution Testing And Related Quality Attributes Published for Comments

In the Pharmacopeial Forum, PF 48(4), a new version of USP Chapter <1094> Capsules—Dissolution Testing And Related Quality Attributes was published. Based on comments received on the version of the chapter official as of December 1, 2020, several revisions are proposed.

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China GMP and Registration of APIs - Q&As

In December 2021, the ECA offered the Live Online Training "China GMP and Registration of APIs". During the Q&A sessions, many interesting questions were posed to the speakers team.

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FDA expands Remote Regulatory Assessments

The FDA would like to use so-called Remote Regulatory Assessments (RRAs) not only during the COVID-19 pandemic, but also beyond it for the asessments of establishments and applications and has published a Draft Guidance for Industry on this.

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New Questions and Answers from the EMA regarding Titanium Dioxide in Medicines

Despite being forbidden as food additive titanium dioxide may still be used provisionally in medicinal products. But the EMA appeals to the pharmaceutical companies to seek intensively for alternative excipients and has published a new questions and answers document to provide assistance. Read here what marketing authorisation holders and applicants have to observe when replacing titanium dioxide or developing new formulations for medicinal products with alternative excipients.

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Ethanol - an important Active Ingredient for Infection Prevention?

WHO, KRINKO and RKI are concerned with the pending biocide approval and indispensability of ethanol as a component of infection prevention and healthcare. They have published a corresponding statement.

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