GMP News

Centralised Procedure: Organisation Management Service (OMS) now mandatory

The European Medicines Agency (EMA) regularly updates the "Questions & Answers (Q&A)" documents on its website relating to centralised marketing authorization procedures. Now, a catalogue with Q&As exclusively on the topic of "Organisation Management Service (OMS)" has been published on the EMA's eSubmission website.

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EMA: Renewed Update of the Q&A Catalogue on "Centralised Procedures"

In October and November, the European Medicines Agency (EMA) once more published on its website the updated and revised version of the "Questions & Answers (Q&A)" document related to questions prior to and during the submission of a centralised procedure.

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Increasing Number of FDA Warning Letters in the Area of Hand Disinfection

As a result of the increased demand for disinfectants, especially for hand hygiene, the number of inferior products with deficiencies in composition and/or approval is increasing rapidly. This is accompanied by an increase in Warning Letters from the FDA to disinfectant manufacturers.

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TGA: On-going use of Remote Inspections

As international travel restrictions remain in place, the TGA's GMP remote inspection programme will continue. This means remote inspections remain the only available option for certification applications during the pandemic.

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WHO publishes Guidance on Safe Production and Quality Control of Monoclonal Antibodies

In October, the WHO published a draft revision of the Guide for the Safe Production and Quality Control of Monoclonal Antibodies. It is a continuation of the guidance documents on this topic that have already existed since 1991.

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New FDA Commissioner - Online FDA Symposium available free of Charge

With Dr Robert Califf, President Biden has now nominated an expert in clinical trials who has previously served as an FDA Commissioner.

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HMPC adopts revised Quality Guidelines for Herbal Medicinal Products

EMA´s HMPC adopted the revised Guidelines on Quality and Specifications for herbal substances, herbal preparations and herbal medicinal products. Will a written GACP declaration for the herbal substance now become a requirement? 

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GDP for APIs used as Starting Materials in Veterinary Medicinal Products: Implementing Regulation (EU) 2021/1280 of 2 August 2021

The Commission Implementing Regulation (EU) 2021/1280 lays down the good distribution practices for active substances used as starting materials in veterinary medicinal products. It applies to importers, distributors, and manufacturers. The Regulation has been binding since August 2021 and is directly applicable in all Member States. We have summarised the most important requirements of the new Regulation.

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GDP Certificates and Wholesale Authorisations Automatically Extended until the End of 2022

In light of ongoing difficulties to conduct on-site GDP inspections due to restrictions arising from the COVID-19 pandemic, GDP certificates and time-limited wholesale authorisations for sites in the European Economic Area (EEA) are automatically extended until the end of 2022.

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Documents Accessible Free of Charge in the Member's Area of the European GDP Association

Do you know that many supporting documents are available free of charge in the member's area of the European GDP Association? To get an idea, take a look here.

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In 2021 again Numerous FDA 483s due to Deficiencies in the Stability Program

Only recently, we reported that in fiscal years 2019 and 2020, deficiencies in the stability programme in the area of "drugs" were mentioned in numerous FDA 483 forms. The FDA has now published the data for the fiscal year 2021. About a fifth of the 483s revolve around the issue of stability.

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USP-NF Stimuli Article on the Use of Apex Vessels in Dissolution Testing

In the current Pharmacopeial Forum, PF 47(6), a stimuli article entitled The Case for Apex Vessels was published.

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JP Drafts Related to Chromatography for Public Comments - Updated Version

We recently reported that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) had published four Japanese Pharmacopoeia (JP) drafts of General Tests and General Information related to Chromatography. The agency has now released a slightly modified version of the draft of new General Test “<2.00> Chromatography”. Comments can be submitted until November 30, 2021.

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Fire in Production! What are appropriate CAPAs?

An interesting case of two fires occurred at an API manufacturer in the USA. This is described in a Warning Letter from the FDA that was recently published.

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FDA issues Warning Letter due to severe Violations of Data Integrity

Recently the FDA issued a Warning Letter due to lack of control over computer systems and violation of data integrity. During the inspection the use of multi user access to raw data files and falsification of records were observed.

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Harmonised General Chapter on Chromatography

The EDQM has announced in a press release that the harmonised general chapter Chromatography was signed-off by the Pharmacopoeial Discussion Group (PDG), which brings together Ph. Eur., JP and USP.

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Testing into Compliance - FDA Warning Letter due to non-compliant GMP Invalidation of OOS results and Falsification of Data

A few but fundamental GMP requirements for pharmaceutical quality control laboratories are a frequent focus of regulatory inspections. During a visit to a U.S. contract laboratory, FDA inspectors found serious deficiencies in these requirements, resulting in a Warning Letter due to inadequate handling of OOS results, lack of electronic system security and data manipulation.

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Compassionate Use: EMA supports Submission of Medicinal Product Information

To support voluntary submissions of medicinal product information for medicinal products supplied in the EU / EEA via parallel importation, or for emergency and compassionate use, new 'Legal basis' values will be made available in the "Article 57 database" (xEVMPD).

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FDA issues Warning Letter for not complying with Clinical Trial Rules

The FDA issued a warning letter for not complying with regulations during the clinical investigation of a COVID-19- IMP. In particular, the sponsor failed to submit an investigational new drug application.

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FDA´s Q&As regarding Clinical Trials during the COVID-19 Pandemic

The FDA updated the Q&As concerning the conduct of clinical trials during the COVID-19 pandemic. The document provides general considerations to assist sponsors in assuring the safety of trial participants & maintaining GCP compliance. Amongst others the guidance deals with electronic signatures, remote monitoring and re-monitoring after pandemic-related restrictions are lifted.

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Results Survey Remote Factory Acceptance Tests (Remote FATs)

Due to the Covid-19 pandemic personal presence of pharmaceutical customers at the supplier site has generally been reduced or even become impossible - especially for FAT. So “remote-FATs” came up more and more in the last year and are still used. But how successful are such remote FATs? What are the problems showing up? This was something we wanted to find out from you, to get an overview - and therefore a survey was set up. Find out what the survey results were.

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IT Infrastructure in GMP Inspections

The validation of computer-based systems is a regular part in GMP inspections. In this context, the IT infrastructure has also become an important topic. Read more about the regulatory requirements and deficiencies in inspection practice.

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EU: Important Document for Inspections revised

The EU Commission has published a revision of the "Compilation of Union Procedures on Inspections and Exchange of Information". This is the eighteenth revision. It mainly involves editorial changes, a few adjustments and two new documents.

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Dissolution Testing in Pharmaceutical Analysis (Part 1)

The dissolution test is a key test parameter routinely used for assessing the performance of solid and semi-solid dosage forms in both drug development and quality control. This article will give a short overview of the test's purpose and the apparatuses according to the European Pharmacopoeia.

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