Christine Oechslein

5 min. reading time

Any action related to medicinal products must be traceable, because the life and health of humans and animals are at stake.

8 min. reading time | by Christine Oechslein

In Part I, Paragraph 2.11 of the EU GMP Guidelines, it is required that "approved training programmes should be available" in GMP-liable establishments.

“While there are clearly defined GMP requirements for particulate and microbial air cleanliness for the sterile manufacturing area, there are no concrete requirements for air cleanliness for the non-sterile manufacturing area. In pharmaceutical practice, terms such as "cleanroom Grade E or F", "grey or black area" and, more recently, the terms "CNC" (classified not controlled) and "NC" (not classified) have become common for non-sterile manufacturing“, explains GMP Senior Expert Christine Oechslein.

The quality of a medicinal product cannot be left to chance, but must be the result of carefully planned actions. The sequence "planning, acting, evaluating, improving" is referred to as "management".

Process validation is ubiquitous and always an important issue in GMP manufacturing and packing. In our today’s feature you can get a first insight into the basics of process validation and learn that only validated processes lead to consistently high quality products.

Carrying out quality testing internally may be a complex process, but it also has many advantages. A solid knowledge of product properties, stability and degradation products is built up over time in a laboratory and can be particularly valuable when carrying out quality risk analysis. However, some tests can be outsourced to external partners.