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”
Category Archives: Pharma
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.
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.