Follow
Any pharmaceutical product must go through a process before it can be used by the public. This process ensures that the product is safe for everyone. And the consumer can be warned in advance if there is any side effect of the product. This helps in deciding for whom the product will be suitable.
However, since pharmaceuticals are an industry and the bottom line is money, some pharmaceutical companies try to bend the rules to declare their products suitable for the public when the effectiveness and side effects of the products are not fully known to everyone.
Before a pharmaceutical product can be used, the company that manufactures it must present evidence of efficacy and safety. For this they have to conduct trial, study, lab testing. ALCOA is used in pharmaceuticals to maintain the quality of collected evidence. Many regulatory agencies such as the FDA, Health Canada and EMEA recommend the use of ALCOA to ensure good documentation practices in pharmaceuticals.
ALCOA in pharmaceuticals is the U.S. Defined by the FDA as attributable, legible, contemporaneous, original and accurate. This applies to all evidence, including electronic, paper-based and hybrid. It helps develop strategies so that the integrity of the evidence is maintained in both research and production. The FDA data integrity warning letter shows its importance in the regulatory market. Aspects of ALCOA in pharmaceuticals are discussed below:
Attributable
This means that the person collecting the evidence or information is responsible for the person collecting it. It ensures accountability. It contains a record of who performed an action and when. This can be a paper or electronic record. A good example of this would be a blood sample taken during a drug test. These samples are taken to understand how the drug is affecting the body. The person taking the sample should mention the time of taking the sample with his name and signature. Also, if corrections are made in the result, the identity and signature of the person who made such corrections should be mentioned.
Legible
Records created, especially paper-based records, should be legible. This is very important in the pharmaceutical industry as a misspelling can lead to the administration of a completely different drug. Records should be persistent and cannot be deleted so that they are reliable throughout the data lifecycle.
Contemporaneous
Contemporaneous means records should be made when measurements are taken. This includes having time and date stamps on data and prohibiting backdating of data. This is done so that consistency is maintained and results can be seen over time whenever required.
Original
Data should be original in the sense that the medium on which it was first recorded should be preserved throughout the product’s life cycle. For example, if the information is first collected in paper forms and then digitized, the paper forms should be kept for the entire life cycle of the product.
Accurate
The information recorded must be accurate, free from errors and biases. No edits should be made to it without noting such edits. For example, witness checks are used to gather important information. Videos of the record making process are also gaining acceptance in this field.
