The short answer ALCOA is five data-integrity attributes — Attributable, Legible, Contemporaneous, Original, Accurate. ALCOA+ adds four more (Complete, Consistent, Enduring, Available) for nine. ALCOA++ adds a tenth, Traceable, and is the form the European Medicines Agency uses for clinical-trial…
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…
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…
Comprehensive Guide to Calibration of Melting Point Apparatus Introduction: A melting point apparatus is used to measure the melting point of a solid (powder) substance. The melting point is the temperature at which a powder or solid substance gets converted…
The friability test is a prime and important physical test of tablets. It is performed while in-process and after finished product analysis. The friability usually is done to know the strength of tablets. If the tablet gets the edge broken…
When we take a tablet as medicine it looks quite good in shape and shining colors but whether it will affect good or not depends on its disintegration properties. Disintegration means releasing drug content in the body on oral consumption.…