GMP News - Quality Assurance

11.05.22

How many FDA inspections still take place in the EU?

Do you know the FDA Data Dashboard? This database offers comprehensive and detailed insights into FDA inspections - right down to the inspection history of individual companies.

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11.05.22

FDA Office of Pharmaceutical Quality publishes Annual Report 2021

The FDA Office of Pharmaceutical Quality has published its annual report for 2021. What does the report say on its eleven pages?

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10.05.22

Are You Recall Ready?

The FDA finalized the guidance on voluntary recalls to help industry initiate prompt recalls of violative products. The guidance covers voluntary recalls of drugs, devices, biological products, food, cosmetics and tobacco products.

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04.05.22

Comments on the new ICH Q9 Guideline Q9 (Quality Risk Management) published

The comment period for the draft revised ICH Q9 Guideline Q9 (Quality Risk Management) published in December ended in March. Now the feedback has been published.

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04.05.22

Brexit: Legal Proposals adopted on the Supply of Medicines in Northern Ireland, Cyprus, Ireland and Malta

The European Parliament and Council agree to proposals from the EU Commission to ensure the continued supply of medicines to Northern Ireland, Cyprus, Ireland and Malta. Both a directive and a regulation are now in place.

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04.05.22

Numerous GMP Deficiencies at OTC Manufacturer in Puerto Rico

The USA FDA has issued a Warning Letter to a pharmaceutical manufacturer for failing to adequately address numerous deficiencies identified during an inspection.

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04.05.22

Revised Technical Guide for Metals and Alloys

Currently there are no compendial standards available for metal packaging systems for pharmaceutical use. Thus any other guidance providing information on metal components like the revised EDQM technical guide “Metals and alloys used in food contact materials and articles” can be useful.

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27.04.22

News on the various Mutual Recognition Agreements (MRAs)

The new annual report of the GMP/GDP Inspectors Working Group has been published and gives a brief but good overview of what is new in 2021. There has also been movement on the MRA with the USA.

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26.04.22

FDA Warning Letter: No Quality Unit, No Thorough Investigations and No Stability Program

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a Californian firm that utilizes Contract Manufacturing Organizations (CMOs) to manufacture nasal spray products. The FDA criticises the lack of a quality unit (QU), an insufficient investigation into microbial contamination and an inadequate stability program.

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26.04.22

Product Transfer: Is a Transfer Plan a required GMP Document?

A frequently asked question in courses on product / technology transfer is: Is a transfer plan a required GMP document?

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13.04.22

FDA moves on with Quality Metrics Reporting Program

The US Food and Drug Administration (FDA) is trying to revive its somewhat forgotten Quality Metrics Reporting Program. Now the FDA is asking for specific feedback.

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13.04.22

US Track & Trace Requirements

The FDA has issued a questions and answers document to assist industry and State and local governments in understanding the effects of the Uniform National Policy on drug product tracing.

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06.04.22

Manufacturer of "Magic Heal" Receives FDA Warning Letter

In March 2022, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to an American over-the-counter (OTC) drug product manufacturer due to significant violations of Current Good Manufacturing Practice (CGMP). The violations were related to identity testing, training, calibration, qualification and quality unit oversight.

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06.04.22

Who needs to review Batch Records?

The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to do so? No, because this is not a requirement.

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06.04.22

Process Validation Deficiencies from the FDA's Perspective - Statistics for Fiscal Year 2021

In our News on FDA Warning Letter Statistics for the fiscal year 2021 (October 2020 - September 2021) you could read that deficiencies for process validation are on place 5. But what deficiencies did the FDA find in process validation?

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