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white bpf Regulatory update and state of the art for the manufacture of sterile pharmaceutical products

- Technician and part of the pharmaceutical, biotechnology and associates involved in the production of clean and sterile products for human, veterinary or experimental
• Update on the latest regulations and documents "state of the art" for the manufacture of sterile pharmaceuticals.
• Give the expected interpretations and discuss future likely changes in this area.

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.



3312812908rating given by previous interns

1 day




800 € HT
(Déjeuner inclus)

PICTO telechargerPDF 01

The regulations USP and FDA, EU cGMP, GMP, EP and WHO as well as making state of the art in specific areas PIC / S, PDA, PHSS, ISO applicable to the manufacture of sterile pharmaceutical products will be reviewed. The interpretation issues or issues requiring additional explanation for their implementation will be particularly discussed. New technologies for aseptic processes will be discussed in light of their power requirement in the future Appendix 1.

Introduction to Annex 1 European GMP
• cGMP Repositories and Documents "state of the art" sterile products
• Major changes to Annex 1 2008 Version

qualifying Classification
• Reference to ISO 14644-2, revalidation frequency
• Integrity test terminals filters, speed and laminarity

particulate monitoring
• Strategy, frequency, location, equipment limitations

microbiological monitoring
• Sampling: where, when, how, how, who?
• Locations to use, fertility control, incubation
• Identification of microorganisms isolated

Bioburden - Sterile filtration
• Bioburden: Appendix 1 80 points
• Sterile filtration: bioburden specification, integrity checks, interpretation PIC / S in January 2010

Simulation of aseptic processes (SPA)
• general principles SPA, SPA preparation of bulk
• Personnel, duration and size, insulators, incubation, anaerobic
• SPA interpretations, differences observed in inspections

Latest manufacturing operations
• Seal: GMP requirements and interpretations
• Controls 100% nondestructive



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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