Reach the new standards for
sterile manufacturers.

We gathered all the information your Business needs to comply with the Good Manufacturing Practices in an exhaustive guide about the newest edition of EudraLex volume 4.

Learn more about all the new challenges posed by the regulations.

  • check markClean Room design
  • check markAseptic processing and validation
  • check markSterility Assurance
  • check markPreparation to visual inspections
  • check markRemediation Plans
  • check markContamination control and prevention
  • check markQuality Risk Assessment and Management

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Want to know more?

Check out the information we collected about the many applications of Annex 1.