Analytical Method Validation
by Method Validation is the process which is established, through laboratory studies, that the performance characteristics of the method meet the requirements for its intended purpose. …
Poor Peak Shape in HPLC
One of the most common peak problems in HPLC is peak splitting or broadening. This can be caused by a variety of factors, (1).column overload, …
HPLC Troubleshooting
High-Performance Liquid Chromatography (HPLC) troubleshooting involves identifying and resolving issues that may affect the performance of the chromatographic system. Here are some common problems and …
SOP FOR DOSSIER
1.0 PURPOSE to lay down procedure for general guideline for the preparation of the dossier for various ROW markets. 2.0 SCOPE The SOP shall be …
Cleaning Validation Sampling in Pharmaceutical
The two main sampling techniques available for cleaning validation are rinse and swab sampling. FDA prefers swab sampling to rinse sampling (4, 5). In many pharmaceutical …
Worst Case Identification in Cleaning Validation
Cleaning is a crucial step in the manufacturing of pharmaceutical products, and it is essential to validate that the equipment is cleaned thoroughly. In identifying …
Quality Management System
A quality management system (QMS) is a collection of business processes and procedures which aims to ensure that the quality of products or services meets …
System Suitability in HPLC Analysis
HPLC chromatographic technique is used in pharmaceutical industries for analysis. System suitability testing limits are acceptance criteria that must met before starting the analysis. There …
MACO and NOEL Calculation for Cleaning Validation
MACO and NOEL calculations have great importance in the pharmaceutical industries. NOEL refers to “No observed effect level” and MACO is a “Maximum allowable carryover”. …
UV-Visible Spectroscopy
Ultraviolet-visible (UV-Vis) spectroscopy is a widely used technique in many areas of science ranging from bacterial culturing, drug identification and nucleic acid purity checks and quantitation, …