Documentation

Master Validation Plan (systems & processes)

  • The equipment is qualified according to cGMP.
  • This includes Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ) - Process Qualification (PQ) is done during the Process Validation.
  • This qualification is the base of a prospective validation of your products
  • A full Cleaning Validation for all equipment is in place.


Mastervalidierungsplan


Batch Documentation

  • After the micronization is completed, each customer receives the batch documentation according to cGMP. This documentation will be stored for 11 years.

Batch Documentation


Secrecy Agreement

  • On request we will conclude a secrecy agreement.