Method Validation and Quality Control Procedures For

Overview of the validation procedures for a vaccine production: from R&D level to the pre-qualification stage

Just like any other process, vaccine manufacturing procedures are defined as a series of interrelated functions and activities using a variety of specified actions and equipment designed to produce a defined product. To assure the reproducibility and consistency of such processes, they must be carried out using validated equipment and under the established procedures that meet all the acceptanc...

Validation of drop plate technique for bacterial enumeration by parametric and nonparametric tests

Drop plate technique has a priority and preference compared with the spread plate procedure, because of less time, quantity of media, effort requirement, little incubator space, and less labor intensive. The objective of this research was to compare the accuracy and fidelity of drop plate method vs. spread plate method by parametric and nonparametric statistical tests. For bacterial enumeration...

Correlation of results between validated in-house analysis method with new pharmacopeia monograph for analysis of Sitagliptin Phosphate API

Having validated analysis methods for medicinal ingredients is attractive for pharmaceutical companies. When a new molecule is introduced to the market, there is not any pharmacopeial analysis method for that. After publishing official methods, correlation between validated in-house methods and the official one could stablish the value of the in-house method. Sitagliptin phosphate is a new anti...

Method Validation and Quality Control Procedures For

Commonly Practiced Quality Control and Quality Assurance Procedures for Gas Chromatography-Mass Spectrometry Analysis in Forensic Urine Drug-Testing Laboratories.

Forensic urine drug-testing laboratories operate in a prescribed scientific and administrative manner to ensure accurate test results. All specimens positive by an initial immunoassay test must be confirmed by gas chromatography/mass spectrometry (GC/MS). To provide adequate control and verification of these analytical processes, laboratories must implement appropriate policies and procedures t...

Analytical Method Development and Validation of Noscapine Hydrochloride: Review

Analytical method development and validation are the continuous and inter-dependent task associated with the research and development, quality control and quality assurance departments. Analytical procedures play a critical role in equivalence and risk assessment, management. It helps in establishment of product-specific acceptance criteria and stability of results. Validation should demonstrat...