GMP News

Cross Contamination Risk: Production stopped

In April, the US FDA inspected a manufacturer of OTC products in Mexico. Due to the deficiencies found, in particular the unacceptable risk of contamination, the production was stopped.

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Sterile Product Manufacturing Process: Warning Letter to Texas Longhorn

After incomplete processing of defects listed in a 483, the Austin-based compounding manufacturer Texas Longhorn received a Warning Letter from the FDA.

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ICH Q5 A (R1) Revision: Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin

In October, the EMA published a revised version of "ICH: Q 5 A (R1): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin" for consultation.

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Warning Letter in the Area of Allogenic Umbilical Cord and Amniotic Membrane Products

During an inspection at the end of 2021, the FDA identified a manufacturer of umbilical cord blood products as lacking approval as well as numerous deviations with regard to common GMP requirements.

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Nitrosamine Impurities: Further Update of EMA's Question and Answer Document

EMA's Q&A document has recently been updated and extended. Read more here about the current limits for nitrosamines and how to proceed in case of new types of nitrosamine impurities.

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FDA: New Inspection Guidance

The US Food and Drug Administration (FDA) has updated two Compliance Program Guides (CPGs) on GMP inspections. One for pre-approval inspections (PAI) and one for routine surveillance inspections.

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USP-NF Stimuli Article on Linearity of Measurement Methods

In the Pharmacopeial Forum, PF 48(5), a stimuli article entitled "Linearity of Measurement Methods" was published.

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EDQM issues monthly CEP Report

Also in September 2022, the EDQM has prepared its "CERTIFICATION MONTHLY REPORT" on the topic of "CEPs" (Certificate of Suitability of Monographs of the European Pharmacopoeia) and has now published it in the EDQM website newsroom.

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Medical Device Warning Letter Statistics for Fiscal Year 2022

The ECA regularly analyses the deficiencies identified in FDA Warning Letters relating to medical devices. Since medical devices can also be part of a combination product of a medicinal product and a medical device, these statistics are also of interest to manufacturers of these products. What do the medical device Warning Letter statistics show for the 2022 fiscal year?

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EDQM Publishes new Document on Revised Ph. Eur. General Chapter 2.2.46. Chromatographic Separation Techniques

The EDQM has announced the availability of a new document in the Knowledge database concerning the revised general chapter 2.2.46. Chromatographic separation techniques. It provides a comparison of the requirements included in the 10th Edition vs. the 11th Edition of the European Pharmacopoeia.

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How to get free Access to FDA 483s

FDA's Office of Regulatory Affairs (ORA) publishes electronic copies of various inspection and related records on their websites.

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FDA Warning Letter: Product Mix-Ups and Insanitary Conditions at US Repackager

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Missouri. The company failed to adequately investigate the presence of foreign tablets in the drug products. Furthermore, during an FDA inspection, one operator was observed to pick individual tablets up off of the floor and place them directly into the feed hopper.

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How to react to Deficiencies after an FDA Inspection?

GMP deficiencies are often identified during FDA inspections. Responding to an FDA deficiency report is important, otherwise a Warning Letter may be issued. But how should one respond?

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GDP Non-Compliance Report: Procurement from Non-Qualified Suppliers

In August 2022, the National Agency for Medicines and Medical Devices of Romania added a new GDP Non-Compliance Report to the EudraGMDP database. The company in question "failed to comply with GDP legislation regarding activities performed (e.g. procuring from entities which are not authorized for wholesaling activities)".

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Shortages and Crisis Preparedness: EMA Publishes List of the Main Therapeutic Groups of Medicinal Products

The EMA has published a list of the main therapeutic groups in order to avoid shortages of medicinal products in the case of a public health emergency and thus to ensure the supply of critical medicinal products. Another EMA document defines the methodology for establishing and maintaining this list and further lists of critical medicinal products.

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The GDP Quality System: What to consider?

Deficiencies in the quality system repeatedly lead to so-called GPD Non-Compliance Reports. But what are the requirements for the quality system in the GDP environment, and which processes must be in place within the company?

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Manufacturing medicinal and non-pharmaceutical Products on the same Equipment - is that possible?

Is it possible to manufacture medicinal and non-pharmaceutical products on the same equipment? The FDA objects to this manufacturing practice.

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Warning Letter to US Manufacturer of Sterile Medicinal Products - Part 2

Particulate contamination and inadequate aseptic working techniques while performing interventions during production once again led to a serious Warning Letter from the FDA. What did the FDA criticise and what did it demand from the American company Cangene BioPharma, LLC dba Emergent BioSolutions?

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USP: Stimuli Article on Mutagenic Impurities published for Comments

Since the beginning of September 2022, the stimuli document "Mutagenic Impurities and Potentially Mutagenic Impurities in the USP-NF" has been published for comments on the USP Pharmacopeial Forum website. Comments and observations on this draft can be submitted until 30 November 2022.

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What is the correct Maintenance of a Pharmaceutical Water System?

To keep a pharmaceutical water system in the qualified state, a suitable maintenance strategy with appropriate maintenance intervals is required. This is demanded by GMP and also makes sense from an operational point of view. Maintenance intervals are already determined in the design phase based on the criticality of the individual components and are specified and controlled in the subsequent commissioning and qualification steps. But which procedures and specifications make sense for the maintenance of a pharmaceutical water system?

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How to Submit Documents with Real-World Data to FDA

To facilitate FDA’s internal tracking of submissions that include real-world data (RWD), the agency published a guidance on how to identify the use of RWD in submission cover letters.

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List of Documents Needed during GVP Inspections

The EMA published a guidance for applicants / MAHs involved in GVP inspections. It includes a detailed list of documents to be provided to GVP inspectors.

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FDA´s Implementation Guide for ICH E2B (R3)

The FDA released a technical specifications document to assist interested parties in electronically submitting ICSRs to the agency. Read more about FDA´s regional ICH E2B (R3) Implementation Guideline.

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Ph. Eur. Cannabis Monograph Proposed for Comment

The European Pharmacopoeia (Ph. Eur.) published the long-awaited draft of the Cannabis flower monograph in Pharmeuropa with a comment period until 31 December 2022. Once finalized and adopted it is expected that the Ph. Eur. monograph will replace the currently existing national monographs.

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Revised Ph. Eur. Chapter on Rubber Closures

The final version of Ph. Eur. 3.2.9. Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders has been published in the European Pharmacopoeia (Ph. Eur.) 11.1. The supplement is now available and will become applicable as of 1 April 2023.

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