GMP News

Revised USP Chapter <831> Refractive Index Published again for Comments

In the Pharmacopeial Forum, PF 48(3), a new proposal of USP Chapter <831> Refractive Index has been published for comments. The text has been revised again to take into account the comments received on the previous proposal published in PF 47(3).

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EMA Publishes Final Guidelines on Quality and Specifications for HMPs

The EMA published the final guidelines (Revision 3) on qualiy and specifications for herbal medicinal products (HMPs). Amongst others, a written GACP confirmation for the herbal substance should be provided.

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New Version of the ICH Q3D Guideline for Impurities published

Since the end of April 2022, the second revision of the ICH "Guideline for Elemental Impurities Q3D(R2)" is available on the ICH website under the heading "Quality Guidelines". This version includes revisions and adaptations in Appendices 2 and 3. Appendix 5 has been newly added.

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FDA plans Rating System for pharmaceutical Companies

The FDA is planning a programme to assess and classify manufacturing sites using surveillance data and company participation. A central point here is also the so-called Quality Culture.

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FDA Updates Guidance on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

The U.S. Food and Drug Administration (FDA) has published a new version (Revision 1) of its Guidance for Industry on Out-of-Specification (OOS) Results. The original version of the document was published almost 16 years ago, in October 2006.

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EMA tackles the Issue of Remote Batch Certification

EMA has today published a draft question and answer document on the remote certification of batches by the Qualified Person (QP).

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FDA Warning Letters for Products Containing CBD and Delta-8 THC

The FDA issued several Warning Letters to companies for illegally selling CBD products and products labeled as containing delta-8 THC. Violations include the marketing of unapproved new drugs, misbranding, and adding delta-8 THC to food products.

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Elastomers for Pharmaceutical Packaging and Manufacturing

Following the recently adopted USP general chapter <665> for plastic materials used in manufacturing, the USP now published two draft chapters for elastomers for pharmaceutical packaging and manufacturing.

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Data Protection of Information Uploaded in the CTIS

To assist sponsors and authorities in fulfilling the transparency requirements set out in the Clinical Trials Regulation, the EMA is preparing a dedicated guidance on the protection of personal data in the CTIS. The agency has published a public consultation document to allow for wider stakeholder input.

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Clinical Trials - ICH E11A on Pediatric Extrapolation

The ICH E11A draft reached Step 2 of the ICH process. The guideline describes the extrapolation framework consisting of the pediatric extrapolation concept and the pediatric extrapolation plan.

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List of Documents Needed during GCP Inspections

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

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PharmEuropa - Revision of Chapter 2.6.30 Monocyte Activation Test

After the revision in 2017, the Monograph 2.6.30. Monocyte Activation Test in the European Pharmacopoeia undergoes a new revision which is open for comments until the end of June.

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Chapter 5.21 "Chemometric Methods Applied to Analytical Data" to be Published in Ph. Eur. 11.1

During its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of general chapter 5.21. Chemometric methods applied to analytical data to be published in Ph. Eur. Supplement 11.1 and be effective as of 01 April 2023.

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GDP-relevant Documents from FDA and USP Currently in Commenting Process

Currently, several GDP-relevant documents from the U.S. Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) are in the commenting process. We have prepared an overview.

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RP for GDP: Which Duties can be Delegated?

The area of responsibility of the Responsible Person for Good Distribution Practice is quite extensive. Therefore, the question arises which tasks actually have to be performed personally and which duties can be delegated.

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FDA posts Webinar on Proposed Rule for the Licensure of WDDs and 3PLs

The U.S. Food and Drug Administration (FDA) has posted a webinar on the proposed rule "National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs)". The webinar aims to help stakeholders submit comments and understand the proposed changes.

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New FDA Draft Guidance "Cybersecurity in Medical Devices"

On 8 April 2022, the FDA published a new draft guidance "Cybersecurity in Medical Devices..." to replace the previous guidance from 2014. Why did the FDA publish this draft?

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Classification of Packaging Changes

Recently, the CMDh has added a recommendation for the classification of a proposed packaging change to the list of unforeseen variations ("Article 5 Recommendations"). What is the recommended category for a change of the “total thickness” for a blister foil?

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How many FDA inspections still take place in the EU?

Do you know the FDA Data Dashboard? This database offers comprehensive and detailed insights into FDA inspections - right down to the inspection history of individual companies.

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How to Demonstrate Comparability of Analytical Procedures

A new Ph. Eur. Chapter 5.27. Comparability of alternative analytical procedures has been proposed in Pharmeuropa 34.2. The comment deadline is 30 June 2022.

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FDA Office of Pharmaceutical Quality publishes Annual Report 2021

The FDA Office of Pharmaceutical Quality has published its annual report for 2021. What does the report say on its eleven pages?

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What is a Pregnancy Prevention Programme?

The EMA has published the "Guideline GVP Module XVI Addendum III - Pregnancy prevention programme and other pregnancy-specific risk minimisation measures" for public consultation.

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Are You Recall Ready?

The FDA finalized the guidance on voluntary recalls to help industry initiate prompt recalls of violative products. The guidance covers voluntary recalls of drugs, devices, biological products, food, cosmetics and tobacco products.

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Update of the EMA Q&As on parallel Distribution of Medicinal Products

The so-called "Frequently asked questions about parallel distribution" for centrally authorised medicinal products were updated in April 2022 and published on the EMA website.

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EDQM updates List of available Reference Standards

Also in March, the list of available reference standards, which comprises more than 3.000 substances, was revised - and the resulting changes, innovations and updates were listed in the newsroom of the EDQM website.

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