Manfacturing of sterile medications according to Annex 1 of Good Manufacturing Practices

Home > Manfacturing of sterile medications according to Annex 1 of Good Manufacturing Practices

Objectives

  • Understanding the general principles required by regulations for manufacturing sterile and non-sterile medications
  • Understanding the developments/changes in the new version of Annex 1 to the GMP regarding manufacturing sterile and non-sterile medications

Audience concerned

Any employee involved in Pharmaceutical regulatory affairs

Aim

Acquiring the basics

Programme summary

  1. Introduction and objectives
  2. Scope of application and principles of the new version for manufacturing sterile and non-sterile medications
  3. Pharmaceutical Quality System specific for manufacturing sterile medications
  4. Staff (specifying specific requirements for manufacturing sterile medications)
  5. Premises (design, isolator, RABS, qualification of ZACs, etc.)
  6. Equipment
  7. Utilities (water, steam system, etc.)
  8. Production and specific technologies
  9. Monitoring the environment
  10. Quality control
  11. Conclusion

Prerequisites

There is no prerequisite for this training.

Duration

1 day
7-hour classroom attendance

Inscription

Download the registration form

Date des formations CaduCeum Academy

Ref : CAGMP1

Informations and registration : academy@caduceum.co.uk