Any pharmaceutical product has to undergo a process before it can be used by the public. This process ensures that the product is safe for everyone. And if there are any side-effects of the product, the consumer can be warned about them beforehand. This helps to decide for whom the product would be suitable.
However, since pharmaceuticals is an industry and the bottom line is money, some pharmaceutical companies try to bend the rule so that their products can be declared fit for the public while the products' effectiveness and side-effects are not fully known for everyone.
Before a pharmaceutical product can be used, the company manufacturing it has to present evidence of efficacy and safety. For this, they have to run trials, studies, and lab testing. ALCOA in pharmaceuticals is used to ensure that the quality of the evidence collected is maintained. Many regulatory bodies such as the FDA, Health Canada, and the EMEA recommend the use of ALCOA to ensure good documentation practices in pharmaceuticals.
Related: FDA’s Top Data Integrity Issues Found During Inspections
Related: FDA’s Top Data Integrity Issues Found During Inspections
ALCOA in pharmaceuticals has been defined by the U.S. FDA as Attributable, Legible, Contemporaneous, Original and Accurate. This is applicable to all form of evidence including electronic, paper-based and hybrid. It helps in developing strategies so that the integrity of the evidence is maintained both in research and manufacturing. FDA data integrity warning letters shows its imporatance in regulatory market. The aspects of ALCOA in pharmaceuticals have been discussed below:
Attributable
This means that the evidence or data collected is attributable to the person collecting it. This ensures accountability. This contains a record of who performed an action and when. This could be a paper or electronic record. A good example of this could be the blood samples taken during a drug trial. These samples are taken to understand how the drug is affecting the body. The person taking the samples should mention the time of taking the samples along with their name and signature. Also, if corrections are made to results, then the identity and signature of the person who made such corrections should be noted.
This means that the evidence or data collected is attributable to the person collecting it. This ensures accountability. This contains a record of who performed an action and when. This could be a paper or electronic record. A good example of this could be the blood samples taken during a drug trial. These samples are taken to understand how the drug is affecting the body. The person taking the samples should mention the time of taking the samples along with their name and signature. Also, if corrections are made to results, then the identity and signature of the person who made such corrections should be noted.
Legible
The record created, especially the paper-based records should be legible. This is very important in the Pharmaceutical industry as a mistaken spelling could result in the administering of a completely different drug. The records should be permanent and not erasable so that they are reliable throughout the data lifecycle.
The record created, especially the paper-based records should be legible. This is very important in the Pharmaceutical industry as a mistaken spelling could result in the administering of a completely different drug. The records should be permanent and not erasable so that they are reliable throughout the data lifecycle.
Contemporaneous
Contemporaneous means that the records should be created at the time of taking the measurements. This includes having time and date stamps on the data and prohibits backdating of data. This is done so that continuity is maintained and the results can be viewed with respect to time whenever required.
Contemporaneous means that the records should be created at the time of taking the measurements. This includes having time and date stamps on the data and prohibits backdating of data. This is done so that continuity is maintained and the results can be viewed with respect to time whenever required.
Original
The data should be original in the sense that the medium it is first recorded in should be preserved throughout the lifecycle of the product. For example, if the data is first collected on paper forms and then digitized, then the paper forms should be kept for the entire lifecycle of the product.
The data should be original in the sense that the medium it is first recorded in should be preserved throughout the lifecycle of the product. For example, if the data is first collected on paper forms and then digitized, then the paper forms should be kept for the entire lifecycle of the product.
Accurate
The recorded data should be accurate, free from errors and biases. No editing should be done on it without making notes of such edits. For example, witness checks are used for critical data collection. Videos of the record making process are also gaining acceptability in this regard.
The recorded data should be accurate, free from errors and biases. No editing should be done on it without making notes of such edits. For example, witness checks are used for critical data collection. Videos of the record making process are also gaining acceptability in this regard.
These standards make sure that the data is collected and processed with integrity. ALCOA in pharmaceuticals helps both the companies and the users by making sure there are no record-keeping errors due to which some sub-standard product is released into the market. Therefore, ALCOA is a necessary tool for maintaining quality in pharmaceuticals and fulfill FDA data integrity requirements.
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