ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate—the five fundamental data integrity principles established by the FDA in the 1990s to ensure pharmaceutical data quality and regulatory compliance. These principles form the cornerstone of Good Documentation Practices (GDP) and…
Unveiling the Science Behind Gas Chromatography: Principle, Instrumentation, and Operational Mechanics Gas Chromatography is a powerful modern-day analytical technique that is used in several chemical and pharmaceutical industries. It is used to separate and identify the components in a mixture…
Principle of Dissolution Test Apparatus Dissolution is the analysis process in which the analyzed substance forms a solution. In this testing measurement of the content and rate of dissolving in the solution from a dosage form, such as a tablet,…
 Imagine releasing a batch of life-saving drugs and you do not want to take any chance with the quality of the product. In pharmaceuticals, method validation isn’t just a checkbox but it’s the shield protecting patients and your company’s…
SOP, Calibration, and features of UV-visible spectrophotometer UV-Visible Spectrophotometry is an analytical technique that is widely used in the pharmaceutical industry for qualitative and quantitative analysis of substances. It works by measuring the intensity of light passing through the prepared…
In electrochemical processes, an electrode plays a crucial role by enabling the transfer of electrons between the solution under investigation and the external circuit. This electron transfer makes it possible to detect and analyze electrochemical reactions, which have numerous applications…
In the quality control department Instrument section is an essential part because every test requires a specific instrument to perform a valid analysis. Karl Fischer titration is very essential in many analyses including finding the water content in any substance.…
Importance of Batch Record Review in manufacturing of drugs Batch record review is an important process in a pharma manufacturing company to maintain the quality of products. It is a periodical process that should be performed within a fixed time…
According to Wikipedia the principle of Polarimeter is “The ratio, the purity, and the concentration of two enantiomers can be measured via polarimetry. Enantiomers are characterized by their property to rotate the plane of linear polarized light. “ Therefore, those…
The principle of Fourier-transform infrared spectroscopy (FTIR) is a technique used to attain an infrared spectrum of absorption of a substance (solid, liquid, or gas) the technology simultaneously collects high-spectral-resolution data over a wide spectral range. This confers a significant…