Pursuing Excellence in Pharmaceutical Quality Control: Best Practices and Insights for Laboratories
This article is written by WANG Laixiu, from the quality department of a pharmaceutical company. Welch Materials is authorized to translate and publish the article on behalf of the author.
Introduction
“Those who persevere succeed; those who press on arrive”. Persistence is the key to success for quality control in our pharmaceutical laboratory. Only by maintaining a relentless pursuit of excellence can we ensure timely issuance of reports and guarantee the smooth progress of production and shipment. Laboratory practices such as data management, document control, and equipment management are all critical to ensuring quality.
In our daily work, we must strictly adhere to the pharmacopeia, corporate procedures, and quality standards to maintain the orderly operation of the entire quality system and stand the test of time.
Firsthand Experience with Welch Columns
The most frequently used HPLC columns in our laboratory are from Welch Materials. They offer high quality, high efficiency, and excellent cost performance. The columns deliver outstanding efficiency and long service life at very reasonable prices. For instance, in one of our new product projects requiring the determination of benzalkonium chloride content, Welch columns provided excellent reproducibility and highly symmetrical peak shapes.
| Column | Part No. | Target |
| Ultisil XB-C8, 4.6×250 mm, 5 μm | 00202-31043 | Benzalkonium chloride |
|
Ultisil XB-C18, 4.6×150 mm, 5 μm |
00201-31041 | Disodium edetate |
| Xtimate Sugar-Ca, 7.8×300 mm, 7 μm |
52108-41052 | Boric acid |
Proper Preparation of Mobile Phases
In HPLC analysis, the preparation of the mobile phase directly impacts the accuracy of the results and the stability of the system. During preparation, we should pay attention to the following:
- Choosing the right solvents: Organic solvents must be of HPLC grade, and ultrapure water should be freshly prepared right before use.
- Proper storage: Aqueous and salt phases are sensitive to light and must be stored in amber glass bottles to prevent microbial growth and salt precipitation.
- Correct filtration: Use clean filtration equipment to filter mobile phases; otherwise, system pressure may rise, or ghost peaks may appear. During filtration, membranes should be rinsed with a small volume of mobile phase to minimize contamination.
- Management of acetonitrile: Acetonitrile may form complexes over prolonged storage. When replacing old acetonitrile with a new batch, bottles must be thoroughly cleaned and the solvent promptly filtered to avoid introducing residual complexes into the system, which could lead to inaccurate flow rates or pressure fluctuations.
Troubleshooting No-Peak Phenomena in Gas Chromatography
During gas chromatographic analysis, if no peak appears, we should consider the following causes and their respective troubleshooting steps.
- FID detector not ignited: Check whether the detector has been properly lit.
- Injection needle blockage: Check whether the injection needle is unobstructed; clean or replace if necessary.
- Column connection issues: Inspect the column inlet for possible leaks or blockages.
Pursuit of Excellence: Details Determine Success or Failure
From ordinary instruments to sophisticated equipment, from method development and validation to instrument qualification and validation, only by upholding an uncompromising attitude toward quality can we ensure product integrity. Every aspect of the laboratory, every small detail, can affect our test results.
By paying close attention to every link in the chain, promptly identifying and addressing issues, and continually optimizing our processes, we can improve work efficiency and enhance product quality.
