Data integrity has very severely impacted the pharmaceutical manufacturing industry across the globe.
'Accuracy and authenticity throughout the life cycle of the document is the requirement of the data that is generated during manufacturing of pharmaceuticals in a pharma company.
Data integrity principles Attributable, Legible, Contemporaneous, Original, and Accurate Complete Consistent Enduring. (ALCOA and C C E) are described just to achieve the above objective'.
Here they are explained in detail.
What is the meaning of attributable?
The document generated in pharmaceutical manufacturing and the data generated for the document should have an owner or creators who has done this work? who has generated the data, the data generated should be attributed to a person who has generated the same.
For example, if one chemist weighs a product for testing his name should be mentioned on weighing slips, or his id should come on the log print. A person doing sample preparation and analysis their name should be reflected in the data with signatures at respective points.
If one person does testing and another writes, report its clear case of violation of data integrity.
Legible: means the document should be readable, even if it is an old document, throughout the life cycle of the document the data should be readable. If an old paper with torned condition and partly visible faded ink is a case of violation of data integrity.
Correct, original and accurate these words themselves give what they demand from data.
Further some more principles are added in as Complete, Consistent, enduring.
Consistent means the data produced should be accurate in a consistent manner, one report is correct and accurate etc. and another violation means there is no consistency. This is a very important aspect of data integrity.
Enduring means the data generated should be such that it remains firm and valid till the life cycle of the product and data.
One of most important point here we must discuss is maintaing integrity of data generated through computer and computerised systems. The computerised systems must be password protected and the individuals must not share their password to others.
How to maintain data integrity?
Only way to prevent violations of data integrity is to educate personnel about the maintaining integrity of data even to those who are actually not directly generating data but might be part of the system.
Educate about the actions taken by regulatory agencies on pharmaceutical companies across the world.
Because of which many jobs were lost, no one likes to violate data integrity, but there should be a proper and continuous education, drills, and inspections to maintain data integrity.
Monitoring individuals' work, training them and giving them proper time, is the key to success in maintaining data integrity.
Another part is disciplinary actions taken by companies, there should not be any tolerance for deliberate violations. Inform personnel about such actions can be taken in advance. These are not advisable because it takes a lot of time and effort to train people to do proper work. Some companies don’t get manpower due to such actions.
Policy of company on maintaining data integrity: The companies with honest intent and transparent business modules try to adhere to data integrity principles but the companies with ill intended habituated to do violations will never comply for data integrity unless they change policy makers itself. Management must be honest to form a policy and implement the same for data integrity.
How to handle instance of a data integrity violation?
Data integrity violation incidence should be recorded as a unplanned deviation. Proper investigation and impact analysis is required to do for the impact of the data integrity violation on the quality of product manufactured in past and in future as well.
Root cause analysis should be done for identification of the reason for the incidence.
Proper corrective and preventive action is required to be taken.
After implantation of CAPA the deviation can be closed by taking action on the persons responsible by providing them proper training and guidance.
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