MICHAEL SCHAEFER
Process Validation
Since years I observe that our medical device industry is still lacking knowledge in equipment qualification and process validation. Many companies are struggling to understand the meaning and purpose of IQ, OQ and PQ. Cumbersome and complex requirements can be found all over the places. Therefore I aim to deliver a basic understanding of process validation and I provide simple templates and examples. Trainings are available including hands-on workshops.
Validation of manufacturing processes for medical devices is a requirement in medical device regulations where the resulting process output cannot be or is not verified by subsequent monitoring or measurement. Activities needed are usually not limited to the validation of the manufacturing process itself but may include as well equipment qualification, computer system validation and test method validation.
In 2017 I was asked to author a TUEV SUED guidance on process validation to support manufactures in fulfilling these regulatory requirements. The guidance document can be found here as well.
Process Validation Injection Moulding – Free example for OQ!
As it is quite hard to find nice examples, Simon Foeger and I wrote an example for an injection molding OQ which can be downloaded for free. It does not intend to be perfect or even bullet-proof and it will offer enough room to be developed further. Enjoy reading and have fun validating your own and real injection moulding process!
Validation of computersystems in manufacturing and QMS
Although it is not a new requirement we can observe many gaps in computersystem validations. Companies are still not compliant to 21CFR820.70(i) and ISO 13485:2016. One reason might be that approaches like GAMP are too complex over overdone for most of the sotfware used. When doing software validations I am following ISO/TR 80002-2 to keep things as simple as possible. In the downloads you can find a checklist and an example (both in German language).
Downloads:
Template Validation Master Plan
Template Validation Change Request
Address
Heiligkreuzstrasse 59,
72379 Hechingen Germany