GMP News - Inspections/Audits


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.



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.



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.



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.



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.



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.



Warning Letter for US Pharmaceutical Manufacturer: Container/Closure Issues and Other Deficiencies

The US FDA has recently published a Warning Letter describing the deficiencies observed during an inspection performed in September 2018 at a US pharmaceutical manufacturer. One serious deficiency concerns leaking product containers. Furthermore, defects in the stability programme, in the CAPA system and in data integrity have also been reported.



MRA Countdown: 10, 6, 4, 2, ...

The FDA has confirmed two other EU Member States to carry out GMP inspections at a level equivalent to that of the US. Only two states are still missing to implement the Mutual Recognition Agreement (MRA) between the FDA and the EU.



Warning Letter for Sterile Manufacturer of Ophthalmic Drugs in the US

In May, the FDA published a Warning Letter to a US American sterile manufacturer of ophthalmic drugs which highlights serious deficiencies, especially in sterile production and in the general understanding of GMP. Read more here.



Fundamental GMP defects at manufacturer of homeopathic drugs

Due to fundamental GMP deficiencies, the FDA has issued a Warning letter to a US manufacturer of homeopathic drugs for human and veterinary use.



Numerous GMP Deviations found at US Manufacturing Site

Due to the deficiencies discovered during an inspection performed in July 2018, the US FDA has now issued a Warning Letter to a US pharmaceutical manufacturer of homeopathic drug products. Microbiological impurities in the products and the water used to manufacture the medicinal products are an essential aspect of the complaint.



MRA EU - FDA has approved two more countries

With the Mutual Recognition Agreement between Europe and the USA, inspections are to be mutually recognised in the future. The FDA's approval of the EU Member States proceeds successively. Two more countries have recently been approved.



FDA Warning Letter: GMP Deficiencies at US Pharma Manufacturer, e.g. in Water System

The FDA has recently issued another Warning Letter to an US pharmaceutical manufacturer describing serious GMP deficiencies. This concerns among others the water system, the QC laboratory and quality assurance.



FDA issues Warning Letter to Manufacturer of Human Cells, Tissue or Cell based Products

The FDA has published a Warning Letter to a manufacturer of umbilical cord blood products for therapeutic use in humans due to deficiencies in the classification and manufacture of the products.


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