Data integrity Principle: ALCOA to ALCOA Plus

Data Integrity Principle 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 important to understand and recreate the event.

To understand better, let us define each of the term of acronym ALCOA PLUS:

Definitions:

Attributable: All generated data must be traceable to the applicable instrument and the person who generated the data. Record should be kept for the date and time of collection or generation of data.

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.

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. Records of any correction made to the data including who has made the correction and when the correction is made, should be kept.

Complete: Complete data means there is no any deletion of data, from the start of documentation including changes made during the life of data.

Consistent: The data should be presented, recorded, dated, or time-stamped in the chronological sequence.

Enduring: The data or information must be maintained, intact, and accessible as an indelible/durable record throughout the record retention period.

Available: The data or information must be easily accessible at any time for review, investigation, trending, routine release decision and inspection or audit, for the defined retention period.

Data Integrity in the Pharmaceutical Industry

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.

Data integrity Principle ALCOA to ALCOA +

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

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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

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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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Friability Testing

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.

Friability Tester

Friability Test Apparatus: Friability test apparatus consists of a drum of a transparent synthetic polymer with polished internal surfaces having minimum static charge. One facet of the drum is removable.

Dimensions: The Internal diameter of the drum is between 283 and 291 mm and a depth between 36 and 40 mm. The tablets fall down with each turn of the drum by a curved projection with an inside radius between 75.5 and 85.5 mm that extends from the middle of the drum to the outer wall. The outer diameter of the central ring is 24.5 mm to 25.5. The drum is attached to the horizontal axis of a device that rotates at 25 ±1 rpm

Friability Testing – Test Method:

For tablets with a unit mass equal to or less than 650 mg, take a sample of whole tablets corresponding to 6.5 g. For tablets with a unit mass of more than 650 mg, take a sample of 10 whole tablets.

Dedust the tablet carefully and weigh accurately the tablet sample. Place the tablets in the drum. Rotate the drum 100 times with a speed of 25 rpm, remove the tablets, remove any loose dust from the tablets as before, and accurately weigh.

Friability Test – Calculation:

Friability (%)  = W1 – W2/ W1  X 100

Where,
W1 = Weight of Tablets (Initial / Before Tumbling) &
W2 = Weight of Tablets (After Tumbling or friability)

Limit : Friability (%) = Not More Than 1.0 %

Generally, the test is run once. If cracked, cleaved, or broken tablets are present in the tablet sample after tumbling, the sample fails the test. If the results are doubtful or if the weight loss is greater than the targeted value. The test should be repeated twice and the mean of the three tests should be calculated. A maximum mean weight loss from the three samples of not more than 1.0% is considered acceptable for most products.

If tablet size or shape causes irregular tumbling, the drum base should be adjusted, so that the base forms an angle of about 10° with the bench top and the tablets do not bind together when lying next to each other, which prevents them from falling freely.

An appropriate humidity­ controlled environment is required for testing of hygroscopic tablets.

Summary:

  • Friability is defined as the % of weight loss by tablets due to mechanical action during the test.
  • Rotate the drum 100 times with a speed of 25 rpm.
  • For tablets with a unit mass equal to or less than 650 mg, take a sample of whole tablets corresponding to 6.5 g.
  • For tablets with a unit mass of more than 650 mg, take a sample of 10 whole tablets.
  • Limit: Friability % : Not more than: 1.0%

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