Elemental and TOC analysis supports pharmaceutical manufacturers in important tasks such as quality control of the concentration of active ingredients in medicinal products. Conformity of the analytical processes with GMP regulations is essential.
The Elementar guide explains how you can design your analysis processes in the pharmaceutical laboratory efficiently and in compliance with GMP.
This guide is helpful in several ways: Find out how typical tasks can be carried out with TOC and elemental analyzers in accordance with GMP and in compliance with the applicable pharmacopoeias. We also show you how we can get you ready for the next audit by qualifying analyzers and 21 CFR Part 11-compliant software.
The guide includes:
- Practical examples with analyzers from Elementar for organic elemental analysis and for the determination of total organic carbon (TOC) in the pharmaceutical industry
- Qualification requirements for analyzers
- Aspects of GMP-compliant and audit-proof software