GMP News

What are the FDA Requirements for Equipment Qualifications?

What are the FDA requirements for equipment qualifications? This is a question that requires a more detailed look into the regulations. However, a current Warning Letter offers a more simple way for information.

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High Conductivity in Pure Steam - possible Causes

The quality of pure steam is determined by its condensate. This has the same quality characteristics as WFI (Water For Injection). The purity of the steam is usually very high due to the phase transition from liquid to gaseous. Nevertheless, in individual cases there may be increased measured values in the test point conductivity and/or TOC. Read about the possible causes.

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GDP-compliant Transport of APIs: What needs to be considered?

GDP is not limited to pharmaceuticals. Rather, GDP starts earlier, namely with the transport of the active pharmaceutical ingredients (APIs) used for production. But what general requirements actually apply to the GDP-compliant transport of active ingredients for medicinal products for human use or veterinary medicinal products?

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GDP Non-Compliance Report for Spanish Wholesale Distributor

The Spanish Agency Of Medicines And Medical Devices has added a new GDP Non-Compliance Report to the EudraGMDP database. During an inspection of a wholesale distributor, a series of deviations from Good Distribution Practice were found. This led to a suspension of the company's authorisation for procuring, holding, supplying and storage by contract of human medicinal products.

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GDP Non-Compliance Report for Austrian Wholesale Distributor

On 09 October 2023, the Austrian Medicines and Medical Devices Agency has entered a new GPD Non-Compliance Report into the EudraGMDP database. The authority blames the company in question for a whole series of GDP violations.

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Why does the FDA inspect in EU despite the MRA?

For fiscal year 2022, the FDA's dashboard lists 168 inspections at pharmaceutical companies in the EU. What is the reason for this?

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Ozempic Falsifications: BfArM starts Investigation

The German Federal Institute for Drugs and Medical Devices (BfArM) has taken over coordination in the case of the counterfeit diabetes drug Ozempic®, as several German states are now actively involved in the case. The agency advises all pharmaceutical companies, wholesalers as well as pharmacies to check all packages of the drug Ozempic® with utmost care.

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Three FDA Warning Letters due to Unanswered Requests for Records

The U.S. Food and Drug Administration (FDA) has issued three somewhat similar Warning Letters. The companies concerned had each failed to respond to requests for records and other information.

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Specify Delta Ferrite in Welds?

The delta ferrite content indicates the proportion of magnetisable, body-centred structure of the iron atoms in the stainless steel. It has an influence on the material properties of the stainless steel, primarily on its corrosion resistance. But how should the content be specified in stainless steel for pharmaceutical equipment or welding seams?

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GMP: Is there something like "planned Deviations"?

One discussion we have again and again at seminars is the question of planned changes. But such terminology can lead to problems.

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What is "Root Cause Analysis (RCA)"?

RCA is an essential part of CAPA processes in the pharmaceutical industry. It helps to ensure that quality problems are solved effectively. There are different tools to get to the real cause of a problem.

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USP HMC publishes revised Cannabis Draft Monograph

The USP Herbal Medicines Compendium (HMC) published a revised version of the previously proposed Cannabis Species Inflorescence monograph. In particular, the Content of Terpenes section has been removed from Specific Tests because there is insufficient information to support the use of terpenes for medical purposes.

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German Federal Cabinet passes Cannabis Act

The German Federal Cabinet has adopted the draft of an "Act on the Controlled Use of Cannabis and on the Amendment of Further Regulations" (Cannabis Law - CanG).

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EDQM pre-publishes Ph. Eur. Cannabis Flower Monograph

As previously announced the new Ph. Eur. monograph Cannabis flower was adopted and will be published in Ph. Eur. Supplement 11.5 in January 2024. Now, the Ph. Eur. decided to make the monograph immediately available on the EDQM website for information.

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EMA: Updates in the Product Lifecycle Management (PLM) Portal

New and revised guidance documents and materials related to ePI (electronic Product Information) are now available on the EMA website under the heading "What's New in PLM?" in the PLM Portal (Product Lifecycle Management Portal).

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BfArM/PEI: Guideline "Designation of Medicinal Products" published

The German BfArM (Federal Institute for Drugs and Medical Devices) and the German PEI (Paul Ehrlich Institute) published version 8.2 of the guideline on the designation of medicinal products at the end of July, which can be viewed on both websites of the institutes. The above-mentioned guideline was fundamentally revised in 2023 and applies exclusively to medicinal products for human use. It is intended to support marketing authorisation holders and applicants in the selection of the designation of the respective medicinal products.

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EDQM: CEP 2.0 implemented

Since beginning of September 2023, the CEP 2.0 is implemented by the EDQM (European Directorate for the Quality of Medicines & HealthCare). From now on, applicants of a new dossier or renewals will receive a CEP 2.0. This will be available as a PDF file in the so called sharing tool "DCEP" and will be signed electronically only.

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EMA's Questions and Answers on the Biological Medicines Marketing Authorisation Dossier Published

Biological medicinal products are gaining more and more interest. Due to the ever increasing complexity and diversity within these medicinal products, more questions arise. The EMA has now published a Q&A document to support the marketing authorisation holders presenting the information in the dossier correctly.

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FDA issues new Guidance on Remote Oversight Tools

The FDA has published a new guidance document on the possible use of alternative methods in the preparation of inspections or in place of inspections for marketing authorisation applications that are still pending.

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USP: Excipient Stimuli published for Comments

In the beginning of September, the stimuli document "Proposed Definitions of Excipient Components- Revisions to 2018 Definitions- PF 49(5)" was published for comment on the website of the Pharmacopeial Forum of the USP. Comments on this draft can be submitted until 30 November 2023.

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FDA Warning Letter for OTC Manufacturer in Arizona

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a U.S. OTC manufacturer. During an inspection, several CGMP violations were found.

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EMA: Q&As on the Topic of "Parallel Distribution" updated

Once again, the "Frequently asked questions about parallel distribution" have been revised and published on the EMA website. The information provided by the EMA on parallel distribution of centrally authorised medicinal products is set out in the Q&A in six paragraphs.

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Warning Letter: A Serious Quality Oversight Issue

The FDA recently issued a Warning Letter to a pharmaceutical company in Florida (USA) for violating CGMP regulations and expectations on Quality Oversight.

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New USP Chapter: Wetting Properties of Pharmaceutical Systems

An expert group of the US Pharmacopoeia (USP) is working on a new chapter on wetting properties of pharmaceutical systems, which may have relevance for both batch and continuous manufacturing. The draft can be found in Pharmaceutical Forum PF49(5).

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Annual Report Forms for Postmarketing Requirements

The FDA published the final guidance on annual status reports and other submissions for postmarketing requirements (PMRs). The reports are intended to facilitate submissions by drug and biological product application holders of complete and accurate information on PMRs and postmarketing commitments (PMCs) in a consistent format.

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