SOP FOR DOSSIER
by 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, …
Detectors for Chromatography
What are detectors in chromatography A chromatography detector is a device used in GC or LC to detect components of the mixture being eluted off the chromatography column. There …
Gas chromatography
Gas chromatography (GC) is an analytical technique used to separate and detect the chemical components of a sample mixture to determine their presence or absence and/or …
Cleaning Validation
What is cleaning Validation Cleaning validation is the methodology used to assure that a cleaning process removes chemical and microbial residues of the active, inactive …