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1
Drug Lifecycle Performance
for Patient Safety
Major deficiencies 2018
AKTEHOM analysis of US/EU/FR non-compliance
issued in 2018
2
Analysis Method
An analysis of all the administrative procedures issued in 2018 from the United States
(FDA), France (ANSM) & from other Health Authorities within the framework of the EU-
GMP non-compliance statement has been conducted by AKTEHOM. The details of which
are in this presentation.
The purpose of this analysis is to highlight the processes most frequently challenged by
these agencies.
The analysis was performed on January 2nd, 2019 following administrative procedures
issued from January 1, 2018 to December 31, 2018 :
- FDA Warning letters from the Office of Manufacturing Quality letters (www.fda.gov)
- EU-GMP non compliance statement from drugs manufacturers
(http://eudragmdp.ema.europa.eu)
- ANSM Injunctions from all health products excepting Cosmetics and Tattoo products
(https://ansm.sante.fr)
A categorization has been performed of every deficiency noted in the inspections and
have been grouped together by AKTEHOM using the administrative procedures , and are
as follows:
- Quality Management System (QMS)
- Production: Non-Conformity
- Data Management
- Process Validation
- Commissioning & Qualification (C&Q)
- Aseptic
- Analytical
- Cleaning Validation
These categories are highlighted as they are the common factor between all the
administrative procedures. Therefore, other observations are not in the scope of this
analysis (specific from a Health Authority).
NB: 483 observations issued by the FDA are published annually at the end of Q1 and are
not part of this analysis. An update will be done once the data is available.
3
Global analysis 2018
Overview: ANSM Injunctions / EU-GMP non-compliance / FDA
Warning Letters
After the analysis of all administrative procedures (98 in total), regardless of the competent Health Authority, the 4 most frequent
inspection deficiencies highlighted are:
- Quality Management System
- Data Management
- Process Validation
- Production Non-Conformity
4
United States analysis 2018
Australia: 2
China:15
Canada: 3
UK: 2
Rep. Dom.: 1
France: 1
Hong-Kong: 3
Japan: 3
India: 10
Mexico: 2
Korea: 7
Spain: 1
Taïwan: 2
FDA Warning Letters
The most frequent inspection deficiencies mentioned in the FDA Warning Letters (WL) are:
- Quality Management System
- Data Management
- Process Validation
Data management is mentioned more frequently WL, as compared to the other Health Authorities.
As shown on the map, the FDA inspects manufacturing sites around the world and more than 75% of WL issued relate to sites located
in Asia.
source: fda.gov
5
China: 4Italy: 1
India: 4
Spain: 1
Taïwan: 1
UK: 2
European analysis 2018
EU-GMP Non-Compliance Statements
EU-GMP Non-Compliance Statements are delivered by Health Authorities from every EU country.
The Quality Management System deficiencies are highlighted in all (except 1) EU-GMP Non-Compliance Statements. Which is then
followed by: Production Non-Conformity, Process Validation, Data Management and Aseptic. These are the most frequent inspection
deficiencies highlighted in this administrative procedure.
As shown on the map, EU-GMP Non-Compliance Statements issued concerns only European and Asian countries.
source: eudragmdp.ema.europa.eu
6
France: 33
France analysis 2018
ANSM Injunctions
The Quality Management System is the most frequent category mentioned into ANSM Injunctions (more than 70% of Injunctions). This
category can be separated into 2 groups:
- QMS : Deviations/CAPA/Change Control ➔ 27%
- QMS : Others (Third-Party Management, Quality Policy,…) ➔ 46%
The QMS is followed by: Production Non-Conformity, Data Management and Aseptic. These are the most frequent observations
highlighted in this administrative procedures.
Injunctions issued by ANSM concerns only manufacturing site based in France.
Currently on 36 different sites there are on-going open injunction proceedings that cover Pharma, DMDIV, Distribution & others.
5 of which are on-going since 2017 and a further 31 injunctions procedures since 2018.
Pharma, 20 DMDIV, 6
Distribution, 6 Others, 1
source: ansm.sante.fr
7
To remember
The most frequent categories that are the subject of administrative procedures in 2018, in order of importance are:
- Quality Management System
- Data Management and Production Non-Conformity
- Process Validation
Within the QMS category, Deviations, CAPA and Change Control processes are highlighted in approximately 23% of all
administrative procedures, even though these processes have been in place for a long time.
Asia is the area where Europe and US Health Authorities highlight the most non-compliance with regulations. Unlike the injunctions
issued by the ANSM which only affect one European country, the FDA's WLs have a worldwide scope.

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AKTEHOM - Analyse des écarts d'inspection EU/US 2018

  • 1. 1 Drug Lifecycle Performance for Patient Safety Major deficiencies 2018 AKTEHOM analysis of US/EU/FR non-compliance issued in 2018
  • 2. 2 Analysis Method An analysis of all the administrative procedures issued in 2018 from the United States (FDA), France (ANSM) & from other Health Authorities within the framework of the EU- GMP non-compliance statement has been conducted by AKTEHOM. The details of which are in this presentation. The purpose of this analysis is to highlight the processes most frequently challenged by these agencies. The analysis was performed on January 2nd, 2019 following administrative procedures issued from January 1, 2018 to December 31, 2018 : - FDA Warning letters from the Office of Manufacturing Quality letters (www.fda.gov) - EU-GMP non compliance statement from drugs manufacturers (http://eudragmdp.ema.europa.eu) - ANSM Injunctions from all health products excepting Cosmetics and Tattoo products (https://ansm.sante.fr) A categorization has been performed of every deficiency noted in the inspections and have been grouped together by AKTEHOM using the administrative procedures , and are as follows: - Quality Management System (QMS) - Production: Non-Conformity - Data Management - Process Validation - Commissioning & Qualification (C&Q) - Aseptic - Analytical - Cleaning Validation These categories are highlighted as they are the common factor between all the administrative procedures. Therefore, other observations are not in the scope of this analysis (specific from a Health Authority). NB: 483 observations issued by the FDA are published annually at the end of Q1 and are not part of this analysis. An update will be done once the data is available.
  • 3. 3 Global analysis 2018 Overview: ANSM Injunctions / EU-GMP non-compliance / FDA Warning Letters After the analysis of all administrative procedures (98 in total), regardless of the competent Health Authority, the 4 most frequent inspection deficiencies highlighted are: - Quality Management System - Data Management - Process Validation - Production Non-Conformity
  • 4. 4 United States analysis 2018 Australia: 2 China:15 Canada: 3 UK: 2 Rep. Dom.: 1 France: 1 Hong-Kong: 3 Japan: 3 India: 10 Mexico: 2 Korea: 7 Spain: 1 Taïwan: 2 FDA Warning Letters The most frequent inspection deficiencies mentioned in the FDA Warning Letters (WL) are: - Quality Management System - Data Management - Process Validation Data management is mentioned more frequently WL, as compared to the other Health Authorities. As shown on the map, the FDA inspects manufacturing sites around the world and more than 75% of WL issued relate to sites located in Asia. source: fda.gov
  • 5. 5 China: 4Italy: 1 India: 4 Spain: 1 Taïwan: 1 UK: 2 European analysis 2018 EU-GMP Non-Compliance Statements EU-GMP Non-Compliance Statements are delivered by Health Authorities from every EU country. The Quality Management System deficiencies are highlighted in all (except 1) EU-GMP Non-Compliance Statements. Which is then followed by: Production Non-Conformity, Process Validation, Data Management and Aseptic. These are the most frequent inspection deficiencies highlighted in this administrative procedure. As shown on the map, EU-GMP Non-Compliance Statements issued concerns only European and Asian countries. source: eudragmdp.ema.europa.eu
  • 6. 6 France: 33 France analysis 2018 ANSM Injunctions The Quality Management System is the most frequent category mentioned into ANSM Injunctions (more than 70% of Injunctions). This category can be separated into 2 groups: - QMS : Deviations/CAPA/Change Control ➔ 27% - QMS : Others (Third-Party Management, Quality Policy,…) ➔ 46% The QMS is followed by: Production Non-Conformity, Data Management and Aseptic. These are the most frequent observations highlighted in this administrative procedures. Injunctions issued by ANSM concerns only manufacturing site based in France. Currently on 36 different sites there are on-going open injunction proceedings that cover Pharma, DMDIV, Distribution & others. 5 of which are on-going since 2017 and a further 31 injunctions procedures since 2018. Pharma, 20 DMDIV, 6 Distribution, 6 Others, 1 source: ansm.sante.fr
  • 7. 7 To remember The most frequent categories that are the subject of administrative procedures in 2018, in order of importance are: - Quality Management System - Data Management and Production Non-Conformity - Process Validation Within the QMS category, Deviations, CAPA and Change Control processes are highlighted in approximately 23% of all administrative procedures, even though these processes have been in place for a long time. Asia is the area where Europe and US Health Authorities highlight the most non-compliance with regulations. Unlike the injunctions issued by the ANSM which only affect one European country, the FDA's WLs have a worldwide scope.