GMP News - Inspections/Audits

08.05.19

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.

02.05.19

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.

25.04.19

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.

25.04.19

FDA publishes Inspection Report for Cells, Tissues and Cell Products

The US FDA published its regular inspection report on Human Cell, Tissue and Cell based Products (HCT/Ps), which also includes current data from 2018.

17.04.19

Warning Letter for US Contract Manufacturer: Cleaning, Contamination Control and Stability Studies criticised

In March, the American authority FDA issued a Warning Letter to a US pharmaceutical manufacturer due to numerous violations of GMP. Among other things, inadequate cleaning of the equipment, errors in the stability studies as well as in contamination control were found.

10.04.19

Inadequate CAPAs lead to FDA Warning Letter

Deviations and CAPA are still hotly debated topics in GMP inspections. This is shown once again by a recent Warning Letter issued by the U.S. FDA.

27.03.19

US FDA Warning Letters for inadequate Batch Records

The U.S. FDA posted new Warning Letters to pharmaceutical companies which ignored basic GMP principles.

20.03.19

Current Q&A on the MRA EU-FDA

The EMA has published a new Questions and Answers (Q&A) document on the Mutual Recognition Agreement (MRA) between the EU and the FDA. Read more about the impact of the MRA on regulatory submissions and variations.

13.03.19

Warning Letter: FDA criticises Supplier Qualification

The full programme is part of a recent FDA Warning Letter, which the FDA sent to a manufacturer in the US only in February: Supplier Qualification, contract management, release procedure.

13.03.19

Switzerland now also uses EudraGMDP

Switzerland has begun to enter information on GMP inspections into the EMA database.

13.03.19

Is an Identity Test needed for the content of all Containers?

In a recent Warning Letter, FDA is criticising a Chinese company for their inappropriate identity testing.

20.02.19

EU-FDA MRA to be expanded

The scope of the EU-FDA Mutual Recognition Agreement (MRA) will be extended to veterinary medicinal products, human vaccines and plasma derivatives.

13.02.19

EU-FDA MRA: Soon all States on board

The MRA with the USA was supplemented by two further countries: Poland and Slovenia. However some are still missing.

23.01.19

Non-Compliance at Chinese Heparin Manufacturer

A Non-Compliance Report due to several GMP violations has been issued to a Chinese heparin manufacturer after an inspection conducted by the Italian Health Authority. This report is now available on the EMA website for Non-Compliance Reports.

19.12.18

Non-Compliance at Italian Sterile Manufacturer

In the course of an inspection conducted in October 2018, the Italian health authority discovered several GMP deviations in the areas of sterile manufacturing, packaging and QC testing at an Italian manufacturer. Read more details about the Non-Compliance Report which can now be found in EMA's inspection database.

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GMP News - Inspections/Audits

MRA EU - FDA has approved two more countries

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

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

FDA publishes Inspection Report for Cells, Tissues and Cell Products

Warning Letter for US Contract Manufacturer: Cleaning, Contamination Control and Stability Studies criticised

Inadequate CAPAs lead to FDA Warning Letter

US FDA Warning Letters for inadequate Batch Records

Current Q&A on the MRA EU-FDA

Warning Letter: FDA criticises Supplier Qualification

Switzerland now also uses EudraGMDP

Is an Identity Test needed for the content of all Containers?

EU-FDA MRA to be expanded

EU-FDA MRA: Soon all States on board

Non-Compliance at Chinese Heparin Manufacturer

Non-Compliance at Italian Sterile Manufacturer

Recommended Event

ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation Part of the ICH Q7 Training Courses 2024

GMP News - Inspections/Audits

MRA EU - FDA has approved two more countries

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

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

FDA publishes Inspection Report for Cells, Tissues and Cell Products

Warning Letter for US Contract Manufacturer: Cleaning, Contamination Control and Stability Studies criticised

Inadequate CAPAs lead to FDA Warning Letter

US FDA Warning Letters for inadequate Batch Records

Current Q&A on the MRA EU-FDA

Warning Letter: FDA criticises Supplier Qualification

Switzerland now also uses EudraGMDP

Is an Identity Test needed for the content of all Containers?

EU-FDA MRA to be expanded

EU-FDA MRA: Soon all States on board

Non-Compliance at Chinese Heparin Manufacturer

Non-Compliance at Italian Sterile Manufacturer

Recommended Event

ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation Part of the ICH Q7 Training Courses 2024

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