GMP NEWS 2022

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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Reverse Osmosis in Pharmaceutical Water - How often to sanitise?

Both in the production of purified water and in the production of WFI with membrane technology, reverse osmosis plays an essential role as the main barrier to impurities of all kinds. For pharmaceutical use the systems including the RO modules should be hot sanitisable. Chemical sanitisation of RO modules is no longer considered state of the art. But how often should hot sanitisation be carried out?

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Warning Letter to US Manufacturer of Sterile Medicinal Products - Part 1

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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Is there a Specification for the Ozone Concentration in hot or cold stored Pharmaceutical Water Systems

Ozone is an effective means for sanitising PW, HPW and WFI systems. But how high should the concentration of ozone be so that the sanitisation effect is sufficient?

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Breakthrough Device Programme of the FDA

The FDA presents its "Breakthrough Device Programme" on their website. What does it say?

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New Article on CDRH Learn

You could already read in the past about the FDA CDRH's website for medical devices. It provides you with the possibility to get familiar quickly with the topic "medical devices" or to stay up to date. What is new?

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Risk Management Plans to Mitigate Drug Shortages also affect Medical Devices

In a draft document, the FDA has presented risk management plans to mitigate drug shortages. What are those plans?

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Revised Ph. Eur. Chapter on Foreign Matter

The final version of Ph. Eur. 2.8.2 Foreign Matter in herbal drugs has been published in Ph. Eur. 11.1. The revised chapter clarifies that the quantitative limits for foreign matter only apply to foreign organs and foreign elements; other foreign elements should, as far as possible, be absent.

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USP publishes proposed Cannabis Monograph

A proposed monograph for Cannabis Species Inflorescence has been published in the USP Herbal Medicines Compendium (HMC). It is open for public comments for 90 days.

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USP-NF Stimuli Article on Analytical Method Precision Comparisons

In the Pharmacopeial Forum, PF 48(5), a stimuli article entitled "Analytical Method Precision Comparisons—A Special Case" was published. It addresses a statistical strategy that has been proposed to compare method precision during the transfer of a validated analytical procedure.

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EMA: New Update of the "IRIS" Documents

In September 2022, the documents "IRIS guide for applicants" and "IRIS guide to registration and RPIs" were updated again - now containing some innovations and revisions.

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PIC/S also publishes revised Annex 1 (Manufacture of Sterile Medicinal Products)

Almost simultaneously with the EU Commission, the PIC/S (Pharmaceutical Inspection Co-operation Scheme) also published the revised Annex 1. What is the background?

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Examples of Analytical Method Implementation

Following the recently introduced new Ph. Eur. chapter 5.26 Implementation of pharmacopoeial procedures, the EDQM published some examples to provide users with practical guidance. How can the critical factors potentially affecting the analytical procedure performance be identified?

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FDA Warning Letter: Potentially Carcinogenic Contaminants in Hand Sanitizers

The U.S. Food and Drug Administration (FDA) has again found genotoxic and potentially carcinogenic impurities in hand sanitizers. In this case, it is about an American manufacturer in whose products benzene, acetaldehyde and acetal impurities were detected at unacceptable levels.

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EDQM publishes FAQs on revised Ph. Eur. General Chapter 2.2.46. Chromatographic Separation Techniques

A revised general chapter 2.2.46. Chromatographic separation techniques has been published in Ph. Eur. 11.0. The implementation date is 01 January 2023. Due to numerous queries received through the EDQM HelpDesk, selected questions and answers have now been published. These complement the series of existing FAQs dealing with the European Pharmacopoeia and international harmonization.

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Revision of USP Chapter <541> Titrimetry

In the Pharmacopeial Forum, PF 48(5), a revision of USP chapter <541> Titrimetry is being proposed. Comments can be submitted until November 30, 2022.

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