What do Typical Manufacturing Processes for Sterile Products look like?

09.02.2026

Question of the Week

The manufacturing process for terminally sterilized products is divided into bulk batch preparation, filtration, filling and sterilization. The primary containers and container closure systems must undergo a special washing process before use.

[GMP Compliance Adviser, Chapter 12.C]

Would you like to discover more?

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

Human Resource Management as a Key to Success

09.02.2026

LOGFILE Feature

Human Resource Management as a Key to Success

The pharmaceutical industry in Germany and other countries, too, faces considerable challenges in the area of human resource management. These problems have far-reaching implications for the competitiveness and innovative power of the industry.

What do Typical Manufacturing Processes for Sterile Products look like?

Here's the answer:

EMA: Reflection Paper on the Qualification of Non-Mutagenic Impurities (NMIs)

The EMA has published a new reflection paper outlining its current thinking on the qualification of non-mutagenic impurities (NMIs). The paper addresses recommended approaches for evaluating the safety of new or increased impurity levels, particularly when such impurities exceed the ICH Q3A/Q3B qualification thresholds and are identified after completion of non-clinical toxicology studies.