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.