GMP News - Inspections/Audits

14.11.18

Valsartan: New Inspection reveals significant GMP Violations

An inspection by EU inspectorates in collaboration with EDQM has revealed significant GMP violations at a Valsartan manufacturer's site.

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02.10.18

Portugal now part of MRA with FDA

Portugal has been accepted by FDA and will now benefit from the EU-US Mutual Recognition Agreement for inspections.

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26.09.18

How FDA will prioritise Inspections

The US FDA has published a so called internal Manual of Policies and Procedures (MAPP) describing how the agency will prioritise its pharmaceutical inspections.

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12.09.18

What are FDA's Expectations from Contract Manufacturers?

In a four-page Warning Letter to a contract manufacturer who produces semi-solid OTC products, the FDA criticizes amongst others the missing tests of starting and finished products.

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12.09.18

Serious GMP Deficiencies at Italian Sterile Manufacturer

On the basis of a GMP inspection performed at an Italian sterile manufacturer, the Italian authority (AIFA) recommended the recall of batches and issued a GMP non-compliance report. Read more about the GMP deficiencies observed.

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12.09.18

FDA Warning Letter to Indian manufacturer due to an insufficient OOS procedure

In July 2018 the US FDA issued a Warning Letter to an Indian sterile manufacturer. The content of the letter primarily affects the inadequate procedure with OOS results. Besides, further deviations like in the visual inspection and the facility maintenance have been criticized.

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05.09.18

Non-Compliance Report for Indian API manufacturer

During an inspection in March 2018, the French competent authority discovered various GMP violations at the site of an Indian manufacturer. Learn more about the Non-Compliance Report issued on behalf of the EMA.

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15.08.18

EMA: More GMP/GDP Inspections performed

Almost 2.500 GMP inspections were performed last year by EU/EEA inspectors. And still many of them in the US.

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01.08.18

Cooperation of international authorities for inspecting API manufacturers

The aim of the International API Inspection Programme is the cooperation of authorities in monitoring and controlling API manufacturers. Read here, by which measures an optimised bundling and efficiency enhancement of the regulatory supervision of API facilities via GMP inspections are to be reached.

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18.07.18

Being inspected by ANVISA?

Quite a few supervising authorities in the health care sector come for GMP inspections also to foreign countries. Read what the Brazilian ANVISA and the Mexican COFEPRIS will expect.

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11.07.18

No more EU Audits in the US?

EU inspectorates already accept inspections of the FDA at US sites. But there will still be auditors coming from the EU to the US.

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04.07.18

The Return of FDA's Quality Metrics Programme

The US FDA announced two updated programmes: the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program.

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27.06.18

Batch Release without a QP - Is this possible?

Batch certification by a QP is one of the essential requirements in the EU GMPs. However one company in Spain has released products to the market without the QP - with reasonable consequences.

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27.06.18

No second chance for a first impression - inspection result by a European supervisory agency

The Maltese competent authority has performed an initial inspection at the facility of an Indian manufacturer and packer in March 2018. This resulted in a Non-Compliance Statement regarding GMP.

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20.06.18

MRA: New Q&As published

The European Medicines Agency (EMA) has published an updated set of questions and answers on the impact of the MRA between the EU and the US addressing questions with GMP relevance.

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