GMP News

Brexit: New Notice to Stakeholders

EU has published a new Notice to Stakeholders on the withdrawal of the UK which summarises the most important aspects in three parts.

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Travel Restrictions: Are Remote Audits an Option?

Because of the Corona crisis, the fact that an auditor has to visit a site currently presents a potential risk to all persons involved or might simply not be possible because of travel bans. What are the options now?

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Shredding Key Documents and Leading Investigators to Incorrect Rooms - An unusual FDA Warning Letter

FDA Warning letters often refer to insufficient documentation, missing validations, inadequate training, employees not following procedures, or similar cases. But shredding documents and leading investigators to incorrect rooms during an inspection is rather unusual.

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Coronavirus: FDA's Advice for the Donation of Cells, Tissue and Products Based on Them

By providing information on the safety of cell and tissue products in relation to coronavirus, the FDA gives support in questions of transferability by donors.

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Serological Tests for HTLV Viruses by Blood and Blood Components

Testing for virus contamination plays an important role in blood and blood components. Recently, the FDA has published a guidance document on testing for T-lymphotropic viruses by means of serological testing.

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Updated Recommendations for Reducing the Risk of CJD and vCJD by Blood and Blood Components

The FDA has revised its assessments and recommendations to reduce the possible risk of transmission of Creuzfeldt-Jakob by blood and blood products.

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COVID-19: Beware of falsified medicines from unregistered websites

The European Medicines Agency (EMA) is urging the general public not to buy medicines from unauthorized websites and other vendors aiming to exploit fears and concerns during the ongoing pandemic.

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Falsified Medicines: MHRA publishes Class 4 FMD Medicines Information

The Medicines and Healthcare products Regulatory Agency (MHRA) is currently investigating an incident where several medicines appear to have left the legal supply chain.

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Deadline Extended: EMA Informs about New Deadline for Risk Assessment on Nitrosamines

The European Medicines Agency, EMA, as well as the EDQM have extended their deadlines for submitting risk evaluations for Nitrosamine Impurities in medicinal products by the Marketing Authorisation Holders.

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EMA on potential Impact of Coronavirus

The EMA and its partners are closely monitoring the potential impact of the outbreak of the novel coronavirus disease (COVID-19) on pharmaceutical supply chains into the EU.

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Foreign Particles in Oral Dosage Forms can also Cause Warning Letter

A US-American medical manufacturer has received a Warning Letter from the FDA due to foreign particles in a solution for oral application and especially regarding the handling of this incident. Besides, further deficiencies were observed during the inspection, such as errors in the evaluation of HPLC data and data integrity in the laboratory in general.

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EU GMP Annex 21 finally published

Annex 21 to the EU-GMP Guidelines (Importation of medicinal Products) has been published as a draft. It summarises the GMP requirements for importers of medicinal products.

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Covid-19: FDA Postpones Domestic and Foreign Inspections

In response to the COVID-19 outbreak, FDA has decided to postpone most foreign inspections until the end of April.

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European Pharmacopoeia: New Chapter on Visual Inspection for Visible Particles Comes Into Force

The new chapter 5.17.2 in the European Pharmacopoeia "Recommendations on testing of particulate contamination: visible particles" was already published for comment in autumn 2018 (Pharmeuropa 30.4). The comments and feedback received have been considered by the Expert Group 12 of the EDQM, and the chapter is coming into force.

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FDA Warning Letter to Indian Manufacturer for Inadequate Testing of Incoming APIs

 In a Warning Letter to an Indian manufacturer, the FDA notes that the firm lacked adequate testing for incoming API and relied on the suppliers' certificates of analyses (COA) without establishing the reliability of the suppliers' analyses through appropriate validation.

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UK Changes Import Restrictions for Cannabis

UK will implement faster access to medicinal cannabis as import restrictions are changed. Thus, patients will be able to get their treatment in days rather than months.

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Lying in an Inspection? Not a good Idea!

A Chinese company was placed on import alert by FDA because investigators observed significant deviations from cGMP. In some cases, the company told the untruth.

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EU implementation of ICH Q12

Following the adoption of the ICH Q12 Guideline in November 2019 the EMA recently published the ICH Q12 Step 5 Guideline and its annexes - together with an Explanatory Note.

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Brexit: MRA will be needed soon

Some major European industry associations call for a UK-EU Mutual Recognition Agreement to avoid drug shortages and other problems.

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Annex 1: Consequences for the QP

The revised draft of Annex 1 (Manufacture of Sterile Products) was published. There are also some things to consider for QPs.

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What are the GMP Requirements for Supplier Qualification?

Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements?

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ICH M9 BCS-based biowaivers and Q&A´s adopted

The ICH M9 Guideline and the corresponding Q&As reached Step 4 of the ICH Process in November 2019.

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QbD for TDS: FDA´s new draft guidance

The FDA published a draft guideline "Transdermal and Topical Delivery Systems - Product Development and Quality Considerations".

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GMP for Sterile Packaging Components

Will the revised Annex 1 provide guidance for the application of GMP to sterile primary packaging materials?

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How does the FDA deal with Processes that cannot be validated?

In an interesting Warning Letter, the FDA replies to a letter from a pharmaceutical manufacturer that had received a 483 deficiency report in which the FDA criticized, among other things, deficiencies in process validation. Read more about the correspondence.

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