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 the maintenance and assurance of complete, consistent, and accurate data throughout the data life cycle

To make it more clear, lets first understand the common terms:

  • Data: The information derived or obtained from ‘Raw Data’.
  • Raw Data: Original records & documentation retained in the format in which they were originally generated (Paper/Electronic) or as a True Copy.
  • Meta Data: The contextual information required to understand the data.

For example: If Analyst “Mr. X” has reported a value of an analyte-A as 99.0 % and Analyte-B as 97.5 % from the HPLC chromatogram. Here, HPLC Chromatogram is Raw data, 99.0 % and 97.5%, is data and Analyst (Mr. X and Analyte A & B) is Metadata.

Regulatory Definitions of Data Integrity

MHRA: “The extent to which all data are complete, consistent, and accurate throughout the data lifecycle.”

USFDA: “Data integrity refers to the completeness, consistency, and accuracy of data.  Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded original, and accurate (ALCOA)”.

PICS: “Data Integrity is defined as the extent to which all data are complete, consistent, and accurate, throughout the data lifecycle”.

WHO: “Data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate”.

ALCOA Principle to maintain data integrity:

ALCOA Principle for Data Integrity

Attributable: All generated data must be traceable to the applicable instrument and the person who generated the data. The date and time of the collection or generation of data should also be recorded.

For example, A correction in the record should be initialed and dated to show when and who made the correction.

Legible: Data should be easy to understand, recorded permanently, and preserved in its original form. There should be no overwriting, All the corrections need to be clearly written with proper justification.

For example, when making corrections to a record, it should be struck using a single line, to ensure the data is legible.

Contemporaneous: Contemporaneous means data should be recorded at the time work is performed. Date and time entries should follow in chronological order. Data should never be backdated.

Original: Source data or Primary is a medium in which the data point is recorded for the first time. This could be an approved form or protocol or a dedicated notebook.

Accurate: To achieve accurate data, the data should be error-free, complete, truthful and it should reflect the observation made. If any correction is made to the data, it should record that who has made the corrected and when it is made.

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.

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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 overcome the problem. How it can be prevented in the future.

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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.

Excessive lighting can cause glare. Glare is of two types disability glare and discomfort glare. Disability glare is the one when there is direct interference of light with vision resulting in impairment. In discomfort glare vision is not directly impaired, but it may cause discomfort, annoyance, irritability, or distraction the condition is called discomfort glare.

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Climatic Zone and Stability Study Conditions as per ICH Guidelines


The climatic condition changes as we move across the globe, which means that the climatic condition is different in a different part of the world. Now since the stability of pharmaceutical product is influenced by climatic conditions, the stability study of the pharmaceutical product needs to be studied keeping in mind the climatic conditions of the country. As per ICH guidelines for stability studies, the climate of the world is divided into four different zones (Zone I, II, III, IV.). Zone IV is further divided into two, zone IV A and zone IV B.

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System Suitability Test Requirements in Chromatography


The operation parameters of the whole chromatographic system can be checked with properly selected SST mixtures. System suitability testing limits are the acceptance criteria that must be met prior to the use of sample analysis.

The system suitability testing limit should conform to criteria provided in guidelines by CDER and other pharmacopeial references like USP and ICH. Some of the parameters which can be checked as SST requirements are: 

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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 […]

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IGIB uses mass spectrometer for coronavirus detection — Science Chronicle

Friability Testing – Friability of uncoated tablets


Friability (the condition of being Friable) testing is a methodology, 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.

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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 […]

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Early detection of cancer using a blood test — cuppascience

A case of coronavirus reinfection in Hong Kong confirmed by genome sequencing


Using genome sequencing, researchers at the University of Hong Kong have found a rare instance of reinfection with novel coronavirus for the second time, four-and-a-half months after the first infection. The first viral genome belongs to GISAID clade V, while the second genome belongs to GISAID clade G. Using genome sequencing, researchers at the University […]

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A case of coronavirus reinfection in Hong Kong confirmed by genome sequencing