Sample Preparation for Quality Control
Last updated: November 2023
Overview
Quality control (QC) is a critical step in the biopharmaceutical industry.
Each manufacturer must demonstrate that its drugs are consistently produced, safe, potent, and pure. The number of tests that must be run by QC labs continues to rise to meet the ever-increasing QC requirements of global regulatory agencies.
Download this infographic to learn four ways to immediately improve the quality of your samples for common QC assays, including high pressure liquid chromatography (HPLC), liquid chromatography– mass spectrometry, ion chromatography (LC-MS, IC), or inductively coupled plasma mass spectrometry (ICP-MS).
- Document type: Infographic
- Read time: 8 minutes
Key Takeaways
- Up to 80% of the problems occurring during HPLC runs are attributable to inadequate water quality.
- Lab balances used to prepare standards must follow US FDA data integrity principles that require data to be Accurate, Legible, Contemporaneous, Original, and Attributable.
- To ensure safe and reliable transfer of even the smallest volumes, pipetting accuracy is essential.
- Filtration to remove particles from samples directly impacts the separation efficiency of the HPLC column and thus data reliability.
This Resource is Designed for:
- QC Microbiologist
- QC Manager
Applications Supported:
- Pharmaceutical Applications
- Quality Control
- Sample Preparation
- Water Quality
- HPLC
- Chromatography
- LC-MS, IC
- ICP-MS
Commonly Asked Questions
Sample preparation technique refers to the way samples are treated to be readied for analysis. These methods include sample extraction, pre-concentration and crushing and dissolution.
Quality control samples are taken from production batches into the testing process to ensure the batch is according to specifications. The purpose of QC is confirm that the new batch meets the quality level of each production batch.
- Preparation of solvents
- Preparation of standards
- Liquid handling
- Filtration
