Reference project

Ensuring conformity of quality documentation and audit preparation

A manufacturer of parenteral nutrition products for premature babies wants to supply its products in the USA. All the quality documentation must be adjusted for this.

EXCO checks the methods of product release to FDA standards in the analytical laboratory sector. Methods are validated; instruments and appliances are qualified. A customized training program for development employees must be defined and implemented in accordance with FDA standard. Before the official inspection, EXCO executes a mock audit (training program).


Implementation
  • GAP analysis (FDA & EMA conformity) for quality controls
  • Implementation of quality assurance management for the analytical laboratory sector: Process description, operating instructions, batch records, production specifications, training certificates, etc.
  • Qualification and validation, particularly:
    • Qualification or re-qualification of laboratory equipment
    • Validation of instrument-specific methods
    • Data audit for cleaning validation
    • Filter validation in collaboration with filter suppliers
    • Support of cleaning validation through sample coordination and documentation
  • Maintenance of documents in the electronic SAP-based documentation management system
  • Review of externally calculated laboratory data for accuracy

In cooperation with EXCO, our client has learned that conformity with the FDA authorities does not mean additional work. Instead, it means a reduction in the workload during daily laboratory operations.

Jörg Petrullat, Project Manager Compliance and Documentation, EXCO GmbH

Customer benefits
  • FDA audit was successfully completed meaning the product could be launched on the American market.
  • Client employees are now being trained in accordance with FDA guidelines.

Client

Pharmaceutical company, Melsungen

Associate Director &
Head of Quality Management

Thomas Wolf

T+49 6233 73778-110