Doris Borchert, PhD

After graduating in pharmacy and receiving a PhD in Pharmaceutical Technology, she started her professional career at Gödecke AG in Freiburg (later Pfizer GmbH) where she developed an FDA-compliant cleaning validation concept for a newly built solids factory.

Other areas of activity included the qualification of facilities and laboratory equipment and the development of a quality assurance system.

After moving to process technology, she worked as Project Manager, responsible for product transfers and the validation of NDA approvals. As a member of an international co-development team, she worked on current issues such as quality by design, Six Sigma and Right First Time. She was also responsible for optimising the process used during the manufacture of solid dosage forms.

Doris Borchert has been using her experience in the fields of quality management, process engineering, production as well as auditing and inspection to support the editorial department of GMP Verlag Peither AG since 2008.

She is author or co-author of the following chapters of GMP Compliance Adviser:

• 8.B How to validate cleaning procedures
• 8.C Cleaning validation master plan
• 8.D Establishing the scope of validation
• 8.E Establishment of limits
• 8.F Sampling procedures
• 8.G Analytical procedures
• 8.H Documentation
• 8.I Maintenance of the validated status
• 8.J Cleaning validation documentation (example)
• 19.F Examples for QRM in the GMP Compliance Adviser
• B.6 International Organisations