Data integrity Principle: ALCOA to ALCOA Plus

ALCOA is a commonly used acronym for “attributable, legible, contemporaneous, original and accurate”. Data needs to be complete, consistent, enduring and available along with all other attributes mentioned in definition. ALCOA Plus includes all the attributes of ALCOA, plus an additional attributes “complete, consistent, enduring and available” as completeness, consistency, durability and availability is importantContinue reading “Data integrity Principle: ALCOA to ALCOA Plus”

Data Integrity in the Pharmaceutical Industry

Data integrity is an important current issue for regulators around the world. The data integrity-related cGMP violations have led to several regulatory actions, including warning letters and import alerts. Data integrity is very important in pharmaceuticals to ensure that the final product meets all the requirements as per standard. Data integrity is defined as theContinue reading “Data Integrity in the Pharmaceutical Industry”

High-Performance Thin Layer Chromatography (HPTLC) Application and Advantages

HPTLC is the improved method of TLC which utilizes the conventional technique of TLC in a more improved way. It is also known as flat-bed or planar chromatography as the stationary phase used is flatbed like surface.

Root Cause Analysis and Tools Used for RCA- Pharmaceuticals

Root cause analysis is a methodology to find the primary cause of problem, by tracking back the actions which lead to the nonconformance(problem) and helps to solve the problem. Root cause analysis is used to identify the problem. What happened? why it happened? and then to determine, what improvements or changes are required to overcomeContinue reading “Root Cause Analysis and Tools Used for RCA- Pharmaceuticals”

Light intensity for Pharmaceutical Area

Lighting at work is very important to the health and safety of everyone using the workplace. Poor lighting can affect the health of the people working in any industry causing headaches, eye strain, and migraine. Poor lighting can harm the business in the form of errors in work, absenteeism, and reduced staff efficiency and productivity.Continue reading “Light intensity for Pharmaceutical Area”

Climatic Zone and Stability Study Conditions as per ICH Guidelines

The stability of the pharmaceutical product is its ability to withstand environmental changes like temperature, humidity, and light for a particular period, without any visible changes.

System Suitability Test Requirements in Chromatography

System suitability test (SST) is a test to determine the suitability and effectiveness of a chromatographic system prior to use.

IGIB uses mass spectrometer for coronavirus detection — Science Chronicle

IGIB researchers have been able to detect novel coronavirus using mass spectrometer. The detection is based on the presence of two unique peptides of the virus. Sensitivity is 95% and specificity is 100% and takes less than 30 minutes from sample preparation to testing. Using mass spectrometer, researchers at the Delhi-based Institute of Genomics and […]Continue reading “IGIB uses mass spectrometer for coronavirus detection — Science Chronicle”

Friability Testing

Friability (the condition of being Friable) testing is a methodology, that is used to see the physical strength of compressed and uncoated tablets upon exposure to mechanical shock and attrition. In simple words, what quantity of mechanical stress tablets will stand up to throughout their production, distribution, and handling process. Friability testing has become an accepted technology.

Early detection of cancer using a blood test

Blood test is one of the simplest, yet most informative weapons in your doctor’s arsenal. A tiny needle prick and a few millilitres of blood can help doctors 1) evaluate how your body’s vital organs like heart, liver, kidneys and thyroid are functioning, 2) diagnose diseases such as diabetes, cancer, heart disease and communicable diseases […]Continue reading “Early detection of cancer using a blood test”

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