GMP NEWS 2019

Drug Shortages due to Brexit: EU gives Answers

The EMA has published a question-and-answer document on possible supply bottlenecks after Brexit.

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Brexit: MHRA clarifies UK PV rules for the no-deal scenario

The MHRA recently published guidance on QPPVs, PSMFs and MHRA PV registration in the event of a no-deal Brexit.

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US FDA Warning Letter to India: Pharmaceutical Water and Other Deficiencies

In January 2019, the US American FDA issued a Warning Letter to a manufacturer from India. Among other things, the pharmaceutical water system was criticized. Read more here.

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Updated Information about the Risk of ZIKA Virus Transmission via Cells and Tissues

Based on the updated information from the CDC, the FDA pointed out the current risk assessment for the transmission of Zika virus through blood, cell or tissue products at the end of February.

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GMP for Cannabis - What is required?

More and more countries allow cannabis for medicinal purposes - But what are the regulatory requirements?

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Monographs on Vaccines and Immunosera - Revised Expert Guidance

During its 162th session, the European Pharmacopoeia Commission published the revised guideline "Guide for the elaboration and use of monographs on vaccines and immunosera for human use", which helps experts and interested parties in this field to prepare and interpret the monographs.

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What are FDA's Plans Concerning New (GMP) Guidelines for 2019? The CDER give answers

What are FDA's plans concerning new guidelines for calendar year 2019? The Center for Drug Evaluation and Research (CDER) has provided an answer to that question in its list of planned guidelines and/or guidelines to be revised.

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Process Validation - FDA criticises Missing Lifecycle

In a Warning Letter recently published, the FDA addressed deficiencies regarding process validation. What did the FDA discover?

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Is the Sanitization Temperature for Water Systems too high?

The most common method of preventing microbiological contamination in a water system is thermal sanitisation. There are systems in which the pharmaceutical water is stored hot and systems that are heated cyclically to an elevated, germicidal temperature. However, excessive temperatures not only increase costs, they can also damage the materials. Read more here.

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Does Purified Water (PW) have to be tested for Endotoxins?

Within the framework of risk analysis, qualification and preparation of sampling plans for new purified water (PW) systems, the question arises as to whether PW should be tested for endotoxins. Read more here.

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US FDA Warning Letters for inadequate Batch Records

The U.S. FDA posted new Warning Letters to pharmaceutical companies which ignored basic GMP principles.

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Brexit: GDP Updates for Import Activities and Air Freight

MHRA has published new Guidance for import and air freight activities. One is introducing a new function, the Responsible Person (import) - RPi.

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Hard Brexit: Liability Risk for Carriers

In the case of a "Hard Brexit", delays in import and export are to be expected. This will affect contracts and liability.

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Delivery of not ordered goods - what to do?

A wholesaler receives a delivery of a medicinal product. However, the order was not placed. What should be done?

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FDA´s Pilot Program for Established Conditions

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced a new pilot program where sponsors can propose established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA) or as a prior approval supplement (PAS).

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Is the review of the Audit Trail required in Clinical trials?

The MHRA recently provided guidance on Data Integrity in clinical trials. Is the review of the audit trail required?

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Short Format Development Safety Update Report

Not all trials are the same in terms of risk. Therefore, the MHRA proposesd a simpler and shorter form in lieu of a full Development Safety Update Report, giving a significant time saving.

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Focus on Cannabis in INCB´s Report for 2018

The International Narcotics Control Board (INCB) recently published its report for 2018 with a strong focus on cannabis. Read more about Cannabis and cannabinoids for medical, scientific and “recreational” use: risks and benefits.

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Revision of the Swiss Drug Law - an Overview

The revised Swiss HMG came into force on 1 January 2019 - with some interesting GMP/GDP-relevant changes.

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Current Q&A on the MRA EU-FDA

The EMA has published a new Questions and Answers (Q&A) document on the Mutual Recognition Agreement (MRA) between the EU and the FDA. Read more about the impact of the MRA on regulatory submissions and variations.

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