Christian Gausepohl

Most companies have established different categories (qualification status) for the suppliers of starting materials and packaging materials they use.

The transfer of a product to a contract manufacturer can be divided into different phases.

When selecting balances, technical aspects such as resolution, precision and weighing range must be taken into account, as must special design features.

“The new Annex 1 requires a comprehensive and overarching contamination control strategy (CCS). It records and links the different aspects and the associated accompanying measures, shows possible interactions and supports a corresponding analysis of any weaknesses or gaps in the system,“ explain Christoph Brewi and Florian Sieder in the GMP Compliance Adviser. 

To err is human - and is only too willingly used as the most probable cause for deviations of all kinds. It is also temptingly easy to look for the cause of error in individual (mis)behaviour. Everyone has a bad day, is distracted or unfocused, forgets or mixes things up and makes mistakes, even though they "actually" know how to do it correctly.

The call for Quality Oversight is getting louder – especially in FDA warning letters there is an increasing number of deficiencies observed in the context of quality oversight.

In today’s feature, Christian Gausepohl presents an approach for implementing Quality Oversight at shop floor level as a collaboration between Quality Assurance and Operations. What are the success factors for this model and how could the organisational structure look like?