Qualification Services

Schubert-Pharma provides reasonably priced validation services that are designed and based on years of experience supplying packaging equipment to the pharmaceutical industry.

Qualification Package

Our GMP offers a compliant validation package that our customers find a very efficient and time saving resource. This package can include but is not limited to the following:

  • GMP Risk Analysis (including workshop with our customer)
  • Functional Specifications
  • Hardware Specifications
  • Software Specifications
  • Factory Acceptance Test (FAT) Protocols (consisting of critical IQ and OQ elements)
  • Site Acceptance Test (SAT) Protocols (consisting of critical IQ and OQ elements)
  • Installation Qualification and Operational Qualification Protocols
  • Traceability Matrix

The complete validation package consists of documentation only and is supplied in Microsoft Word and Adobe (pdf) files so that customers can expand and re-use these documents for future activities on the projects they are purchased for.

Of course custom or special customer requirements for FAT, SAT and Qualification documents can be developed.

Validation Support

Schubert-Pharma will gladly support its customers with the performance of validation activities not only at Schubert but at the customer’s site as well.

  • FAT and SAT support/execution
  • IQ and OQ support/execution

For further information please contact