GMP NEWS 2020

Non-Compliance Report for German Wholesale Distributor Published

The competent authority of Germany has entered a new GPD Non-Compliance Report into the EudraGMDP database due to the discovery of serious GDP non-compliance at a German wholesale distributor.

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Still no remote FDA Inspections: Criticism grows

Since the beginning of the pandemic and the associated travel restrictions, the FDA has been hesitant to decide whether to conduct distant assessments. Now, more and more criticism is spreading.

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Avoiding Non-Compliance in Packaging Areas

Filling product into open containers with leaks above the packaging lines? Not a good idea - A current FDA Warning Letter provides information.

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Swissmedic clarifies Validity of GMP Certificates during the COVID-19 Pandemic

The Swiss Agency for Therapeutic Products Swissmedic has published a press release clarifying the validity of GMP certificates during the COVID-19 pandemic.

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Cloud Computing: Regulations for the Return Transmission of Data in the Event of Business Discontinuation

The issue of data integrity generates a multitude of questions. Current questions are addressed in a loose sequence of News. Question 10: What regulations must be in place to ensure that in case of business discontinuation (insolvency) of a cloud service provider, the data is completely returned to the client?

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UN Commission Reclassifies Cannabis

The United Nations (UN) Commission on Narcotic Drugs (CND) has decided to reclassify cannabis. With this, the Commission followed the WHO recommendation of 2019.

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EMA Distant Assessment Guidance

EMA has published a Guidance document, providing points for consideration relating to Distant Assessments.

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The Influence of Process Changes on Process Validation

What influence can process changes have on process validation? A current FDA Warning Letter provides information on this.

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Warning Letter due to Inadequate Pressure Stage Concept and Particle Monitoring

Due to deficiencies in the ventilation system and particle monitoring in the sterile area, an Indian pharmaceutical manufacturer has recently received a Warning Letter from the U.S. FDA. In addition, the microbiology testing was also criticized.

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Blind Trust in Supplier Certificates and Inadequate Final Testing - An Analysis of FDA Warning Letter

A look at the warning letters to pharmaceutical companies of the last nine months of the current fiscal year (Oct. 2019 - June 2020) shows the most frequent GMP violations found by FDA inspectors. Read more about the Warning Letter Analysis in this article of the GMP Journal

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FDA - Notification of Deviations in Cell and Tissue Products

An FDA document on Biological Product Deviation refers to products based on human tissues or cells.

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New FDA Guidance on Cellular and Tissue Products (HCT/Ps) published

During  2020, the FDA updated and expanded its series of guidelines on the topic of cell and tissue products with a revised version of the Guideline Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.

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FDA publishes Information and Reviews of Biological Research Projects

In addition to the publication of a large number of guidelines and supporting documents in the field of cell and tissue products, the FDA also provides insights into the biological research projects of its scientists on its website.

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FDA explains Background of Emergency Use Authorizations related to COVID-19 Vaccines

Recently, the FDA published a Q&A Paper on their website that answers the most common questions about the emergency approval of COVID-19 vaccines and explains the underlying process.

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Will CBD be Controlled as a Narcotic?

Will Cannabidiol be controlled as a narcotic in the future? This question is currently intensively discussed. The European Court of Justice recently released their opinion.

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FDA Warning Letter for not Adequately Testing Components prior to Use in the Manufacture

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Mexican manufacturer. According to the FDA, the firm did not adequately validate the process and qualify the equipment used to manufacture the drug products. Furthermore, the company did not adequately test components prior to use in the manufacture of drug products destined for the US market.

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EMA Publishes New Q&A Guide on Brexit

There are only a few days left until the UK will leave the EU. On 01. January 2021 the UK will be considered a "Third Country" with massive consequences for the GMP environment for medicinal products and APIs. Now the EMA published a new Question and Answer Document which clarifies a number of questions which have been raised during the Brexit negotiations. Please read more about EMAs Q&A Document

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ECA Good Practice Guide Integrated Qualification and Validation - Final Version

A Task Force with members from the pharmaceutical industry, plant manufacturers and engineering companies has created the ECA Guide. The Guide was designed based on the requirements of EU GMP Annex 15 and supplemented by aspects of ASTM Guide 2500. The Annexes are very important for the applicability of the Good Practice Guide. They contain sample documents and templates that are successfully used in the pharmaceutical industry and in plant engineering and construction. Read more about the Guide in the GMP Journal Article.

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EMA - Public Meeting on COVID-19 Vaccines

Due to the great public interest and the varied discussions, EMA organises a public meeting on Covid-19 vaccines and the role of EMA in the approval process, which all interested citizens can attend via live broadcast.

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Covid-19: Swissmedic adapts Inspections

Swissmedic inspections may be carried either out on-site, (partly) by means of remote assessments or at a later point in time.

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