GMP News - Inspections/Audits

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.

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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.

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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.

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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.

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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.

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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.

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13.03.19

Switzerland now also uses EudraGMDP

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

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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.

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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.

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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.

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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.

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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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11.12.18

Poor GMP/GDP Practice found in US Warehouse

In a warehouse in Arkansas, USA, the US Food and Drug Administration (FDA) found "alarming" insanitary conditions.

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28.11.18

MRA: FDA accepts four new States

The US Food and Drug Administration (FDA) announced that it accepted four new states, which will now benefit from the EU-US Mutual Recognition Agreement MRA.

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21.11.18

A global Approach to Classification of GMP Deficiencies?

PIC/S adopted a new Guidance on Classification of GMP Deficiencies. It supports the global harmonisation of the classification of GMP deficiencies.

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