GMP NEWS 2019

EMA's Annual Report on the EudraVigilance Database

The EMA has published the Annual Report 2018 on EudraVigilance summarizing the current status of the database.

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FDA's Office of Pharmaceutical Quality gives an Overview of its Activities 2018

The Office of Pharmaceutical Quality (OPQ) was established in 2015 within the FDA as part of the Center for Drug Evaluation and Research (CDER). The aim was to ensure the quality of medicinal products throughout their entire lifecycle, from development to commercialisation. Now, the FDA's OPQ has reviewed the year 2018 and published a 13-page report.

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GMP for Sterile Containers

Following the Q&As on what data is required for sterilization processes of primary packaging materials published in 2016, the EMA recently released the new Guideline on the sterilization of the medicinal product, active substance, excipient and primary container.

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Warning Letter for US Contract Manufacturer: Cleaning, Contamination Control and Stability Studies criticised

In March, the American authority FDA issued a Warning Letter to a US pharmaceutical manufacturer due to numerous violations of GMP. Among other things, inadequate cleaning of the equipment, errors in the stability studies as well as in contamination control were found.

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Critical Process Parameters and Process Validation

Regulations require that the critical process variables should be included in validation. This has been recently confirmed again by the FDA in a Warning Letter.

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FDA establishes a working group on cannabis and cannabis-derived products

There is currently a growing interest in the development of therapies derived from cannabis and its components.The FDA recently announced to form an internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD.

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Inadequate CAPAs lead to FDA Warning Letter

Deviations and CAPA are still hotly debated topics in GMP inspections. This is shown once again by a recent Warning Letter issued by the U.S. FDA.

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USP Published New Drafts for General Chapters on Plastic Materials

In the current issue of the Pharmacopeial Forum, the USP general chapters on plastic packaging materials have been re-published for comment.

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EMA Guide on Sterilisation for Medicinal Products, API Excipients and Primary Packaging published

At the beginning of March, the EMA published a guideline for the sterilization of drugs, active ingredients, excipients and also primary packaging.

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What does the FDA expect from Cleaning Validation today?

FDA's regulations regarding cleaning validation are now relatively old. A GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES dates back to the early 90s. In this context, Warning Letters show the "current thinking" of the FDA.

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Brexit: Importation of IMPs from approved countries in a no deal scenario

The MHRA recently provided guidance on how the management and oversight of the import of investigational medicinal products (IMPs) from listed countries will work in a no deal scenario.

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Monitoring of Clinical Investigations: FDA´s Q&As on Data Integrity

The FDA provided additional guidance on risk-based monitoring for effective oversight, including Data Integrity. Read more on FDA`s draft Guidance for Industry A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.

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ICH M10 - Draft Guideline on Validation of Bioanalytical Methods published for public Comments

On 13 March, the Euroepan Medicines Agency (EMA) published a the draft ICH Guideline M10 on bioanalytical method validation for public comments.

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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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