GMP News - Inspections/Audits

02.10.19

FDA criticizes Lack of Compliance with ICH Q7 Guidance

According to the U.S. FDA, the Chinese firm failed to establish an adequate quality system and lacks quality oversight on documentation.

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02.10.19

How to prepare for ANVISA Inspections

Quite a few authorities in the health care sector come for GMP inspections, also to foreign countries. Here you can read what the Brazilian ANVISA will expect.

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26.09.19

Another FDA Warning Letter due to Deficiencies in the Water System

Again the US-American FDA has issued a Warning Letter which primarily describes defects in the water system as well as deficiencies in the handling of CAPA & OOS and in the cleaning.

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18.09.19

No more FDA Inspections in the EU - really?

The Mutual Recognition Agreement (MRA) between the EU and the US is now in force as planned. But does this really mean the end of all FDA Inspections in the EU?

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18.09.19

Warning Letter due to Cross Contamination

In August, the US FDA issued a Warning Letter due to cross-contamination with penicillin in areas for non-beta-lactam production.

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11.09.19

No Documentation in the Inspection? Not a good Idea!

A company in China has created GMP documents only for the purpose of inspection. With serious consequences.

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28.08.19

Warning Letter for Indian Sterile Manufacturer

Indian sterile manufacturer Emcure Pharmaceuticals has once more received a warning letter from the FDA with concerns to the root cause analysis of deviations in sterility testing.

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21.08.19

Warning Letter due to Deficiencies in the Purified Water System

In June, a US-American pharmaceutical manufacturer received a Warning Letter from the FDA due to deficiencies in the Purified Water System which concern - among other things - the design of the water system, monitoring, sampling and handling of CAPAs.

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21.08.19

MRA: Can Import Testing be completely stopped now?

The MRA with the USA is now in force as planned. But there is a lot to be considered in order to stop import testing.

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19.08.19

Warning Letter due to GMP Deficiencies in Tableting

An Indian manufacturer of solid dosage forms recently received a Warning Letter from the US FDA after the authority had revealed serious deficiencies in the tablet production.

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19.08.19

Comprehensive FDA Warning Letter Analysis - Stability Testing on the Rise

Over and over again, FDA inspectors discover violations of long-established GMP requirements. Read more about which trends in the areas of quality control and production can be identified from the analysis of the Warning Letters issued in the last 21 months.

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24.07.19

MRA EU-USA: All EU Member States Accepted

In a previous news it was pointed out that one EU Member State (Slovakia) was still missing for the complete implementation of the MRA agreement between the EU and the USA. The goal was for all EU Member States to be recognised by 15 July 2019. Now, this goal has been achieved.

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10.07.19

New Warning Letters - Quality Units in the Focus

"Your firm's quality systems are inadequate". A sentence in a Warning Letter you would not like to read. Some companies now had to.

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03.07.19

Serialisation: New Guidance for EU Inspectors

The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the safety features regulation.

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26.06.19

How to prepare for Russian Inspections

Quite a few authorities in the health care sector come for GMP inspections also to foreign countries. Here you can read what Russian inspectors will expect.

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