Process Validation

Process Validation

I have a solid experience in validation of processes (DQ, IQ, OQ, PQ) according to the requirements of ISO 15378, ISO 13485, 21 CFR part 820, GMP (Good Manufacturing Practices) and GHTF - Process Validation Guidance.

My experience includes all steps in the validation process:

DQ – Design Qualification

IQ – Installation Qualification

OQ – Operational Qualification

PQ – Performance Qualification

After many years in the plastics industry with production of primary packaging for medicine, I am very experienced in validation of injection and blow molding of plastic parts (injection molding, injection blow molding & blow molding) as well as filling and assembly processes.

During my work as a consultant, I have helped small and large companies to establish or improve their process for validation of internal and subcontracted processes. I have also completed training in process validation for employees in quality, production and R&D.

In order to have a risk-based approach to process validation, I have helped companies with risk management of their and their subcontractors' processes based on FMEA (Failure Mode & Effect Analysis).

I also helped them to define the requirements for URS (User Requirements Specification) and to set-up a procedure for software validation.


Relevant links:

21 CFR part 820:

GHTS – Process Validation Guidance:

Medical Device Regulation: