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white bpf L'Annexe 1 des GMP Eu

- Setting the pharmaceutical and biotechnology industries concerned with the production of clean and sterile products for human, veterinary or experimental
• Have good knowledge of the critical points of Annex 1 European GMP (v. 2008).
• Understanding the expectations of the European health agencies on these critical points for a consistent and rational implementation.
• Take stock of industrial practices and even mistakes.

En début de session, grâce à un questionnaire, le formateur analyse le niveau de connaissances des professionnels sur le sujet ainsi que leurs attentes des connaissances à acquérir.
Le formateur adapte le programme de la formation en fonction du profil des différents participants. Un temps est consacré aux échanges d’expériences entre participants et avec le formateur.
Pour un bon suivi du stage, le stagiaire dispose d’un ou plusieurs supports de cours en version numérique et en version papier.


17 8given by previous interns

2 days



1 200 € HT
(Lunch included)

PICTO telechargerPDF 01


The main critical points of the revised Annex 1, v. 2008 are the classification and monitoring of Zacs, validation of aseptic processes, the bioburden before sterilization and sealing operations / crimp vials. Other critical points continue to be discussion topics as microbiological monitoring. These critical points often pose interpretation problems to manufacturers, the text is not always very explicit on the practical implementation of these new requirements. From the history of the creation of the text, various documents and work of the PICs, industrial practices and experience of the facilitator, these key points will be interpreted one by one for a consistent and pragmatic implementation on industrial sites.

Genesis of 2008 Version

Result of a recent survey on the implementation of the new recommendations for environmental monitoring of Annex 1 in France

Analysis, interpretation and comparison with regulations FDA / USP and WHO the following critical points:
- Classification of particulate ZAC
- Particle Monitoring ZAC
- Microbiological Monitoring ZAC and staff: samples (where, when, how, how, who?), Backgrounds, incubation, identification
- Simulation of aseptic processes (MFT, SPA, etc.)
- Crimping operations
- Assessment of bioburden before heat sterilization and filtration
- Some key points of control contamination and Good Practices Aseptic

Excess and deficiency of current interpretations, the main points still unfulfilled, probable changes in the supervision of different types of aseptic manufacturing

Évaluation des connaissances acquises et évaluation des actions d’améliorations entreprises et/ou envisagées

Questionnaire de satisfaction

Cette journée s’inscrit dans le cadre de la formation professionnelle.
N° Déclaration : 82 69 13448 69 Préf. Région Rhône-Alpes
SARL au capital de 10 000 Euros Siret 451 934 541 00025


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