Warning Letter: Deficiencies in Validation and OOS
Once again, an Indian pharmaceutical manufacturer has received a Warning Letter from the US-American FDA due to deficiencies discovered during an inspection. The Letter focuses on deficiencies in the validation and the handling of OOS results in the laboratory. Read more here
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.
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.
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?
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.
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.
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.
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.
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.
The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the safety features regulation.