GMP News - Quality Assurance

26.01.21

Survey Results on "Remote Audits" of Notified Bodies

Within the framework of a survey via the EU Commission, Notified Bodies in the medical devices sector were asked about their experiences with "remote audits". The results are now available.

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20.01.21

Distant Assessment - an Option for the Future?

Due to the current pandemic and the associated restrictions, assessments are increasingly being performed remotely. Are these Distant Assessments also an option for the post-pandemic period?

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19.01.21

Distribution of Temperature-Sensitive Pharmaceuticals: Requirements according to the EU GDP-Guidelines

With the approvals of various COVID-19 vaccines in many countries, the question arises how to safely transport the serum from the production sites to the storage and distribution centres and then on to the local vaccination centres. However, this question does not only arise for COVID-19 vaccines, but also any other temperature-sensitive product in general. The EU GDP-Guidelines contain some specific requirements for temperature-sensitive products in this regard.

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13.01.21

Brexit Agreement - what now?

Brexit: The agreement on the future relationship between the European Union and the United Kingdom is here. What are the consequences for medicinal products?

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13.01.21

ICH Q9 Risk Management to be Revised

Since 2005, the ICH Guideline Q9 has been the state of the art when it comes to quality risk management (QRM) in the GMP environment. Now it is to be revised. What is planned?

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05.01.21

FDA Warning Letter: No Adequate Quality Unit, Laboratory Controls, Sampling Plans, and Stability Program

The U.S. Food and Drug Administration (FDA) recently sent a warning letter to a US over-the-counter (OTC) drug manufacturer due to significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

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16.12.20

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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16.12.20

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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16.12.20

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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09.12.20

EMA Distant Assessment Guidance

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

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09.12.20

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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02.12.20

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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02.12.20

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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25.11.20

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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18.11.20

Brexit: Phased Process for implementing Medicines Regulation in Northern Ireland

An agreed approach had been reached on a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021.

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