ANSM & ANSES Inspection

Preparation and support for Inspections by former ANSM & ANSES inspectors

Since November 1, 2017, the mutual recognition of inspections of manufacturing sites for drugs for human use between the United States and eight member states of the European Union, including France only reinforces the obligation for laboratories to be ready to pass these inspections in the best condition.
Axys-Network has developed an “Inspection readiness” product based on a double approach:
· The course of an inspection entirely modeled on that of the ANSM and carried out by former inspectors of the ANSM and the ANSES,
· In parallel with this mock inspection, recommendations based on knowledge of practices, doctrine and agency interpretation on the various subjects encountered

The objective 

We organize a training mission for the staff of your establishment at your home, allowing you to successfully undergo a GMP certification inspection to ANSM standards.
The mission, depending on the choice of the establishment, can be carried out unexpectedly or not, be a system inspection, product inspection or inspection for cause or FDA type. The mission aims to give the keys to successfully complete the inspection and its closure in order to facilitate responses to the report.
In a realistic context, the mission trains staff to inspection interviews. On this occasion, the training makes it possible to understand the point of view of the inspector during the investigations and the meaning of a deviation. How to listen to the inspector justify and / or group the differences. How to give meaning to the diagnosis and determine its weaknesses and strengths.

The Mission (1)

A first contact with the Responsible Pharmacist or his representative is established in order to set the objectives of the mission and in order to know beforehand the potential weaknesses and failures of the targeted site.

                                                                                                                               Preparation phase :

Our consultant prepares, under the conditions of a GMP inspection, the inspection program. It assesses the time required for the actual inspection as well as the "training" impact desired by the customer, taking into account data and comments from the first contact with the client.
This preparation requires the study of the following elements (communicated beforehand):Inventory of the establishment (including detailed plans)
  • Last inspection report,
  • Latest requests for changes, (if applicable)
  • Quality Manual,
  • Master procedures (possibly).
The study of these elements allows our consultant to detect the particular points to be assessed in priority in the workshop or on file.

The deliverable consists of the inspection program listing the subjects to be discussed, the time proposals and the documents, inspection supports, which the consultant must have at J1 (The schedule should not be communicated to the teams in order to respect the methodology ANSM).

The  Mission (2)

On-site workshop as a preamble to the inspection (1/2 day)

   o   How to organize (Front room-Back room)
   o   How to behave

   o   How to answer


Inspection on site

The investigations are carried out according to the usual procedures. In the event of a report of a possible deviation, the consultant makes a provisional point on his expectations and the item of GMP targeted. On each topic mentioned, our consultant takes the necessary time, with the operators and managers present, to indicate the objective and methodology of the approach.
Our consultant stops the investigations ½ hour at the end of the day to reconcile the observations and consolidate the differences. This allows a point to be made at the end of each day with those responsible for the organization, the discrepancies noted and the means envisaged to resolve them with regard to the inspector's expectations. This also makes it possible to implement curative measures without delay responding to certain deviations noted.
A closing meeting made, on the last day, the organizational assessment, the presentation of the deviations with their criticality. The managers will present the solutions proposed.

Communication of the inspection report with classification of deviations and risk factors and prioritization within one month.


A retrocession day is organized after sending the inspection report
The action plan proposed by the client will be evaluated by the consultant

Other services 

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Non Compliance