Data Integrity Survey Results : Pharmaceutical Guidelines

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Data Integrity Survey Results

Everyone in pharmaceutical is aware about the data integrity but a lot of companies still have serious issues. Many of them don't have even the procedure for data integrity.
We had conducted a data integrity survey that has amazing results. 3360 visitors of pharmaguideline.com participated in this data integrity survey and 87 % of them were from India. There were 8 simple questions regarding data integrity. Questions had options to select and all were mandatory to answer. These are the results and their interpretation.

Q1. Does your company have Standard Operating Procedure for data backup and deletion for HPLC/GC/UV-Spectrophotometer etc.?
29% of pharmaceutical companies don't have an SOP for the data backup of instruments like HPLC, GC and UV spectrophotometer. It means about one third pharmaceutical companies don't have care about data of the important analytical instruments.

Q2. Does your company have the procedure to review data integrity?
23% of pharmaceutical companies don't have a procedure to review the data integrity. Without any procedure, how these companies can implement data integrity, its a big question. This figure shows that only 77% of companies have implemented the data integrity and 21 CFR part 211 guidelines.

Q3. Do you know the requirements of 21CFR compliance?
This question was asked in addition to the last one. 21% of employees of the pharmaceutical are not aware of the requirements of the 21 CFR compliances. it ensures that more than 20% of companies have not implemented the data integrity procedures.

Q4. Do the employees in your company share user IDs for GC/HPLC/FTIR/UV instruments?
User IDs of analytical instruments are shared by the employees of 30% of pharmaceutical companies. Sharing user IDs during analysis is a serious data integrity violation but analysts of these companies share login credentials for the analytical instruments.

Q5. Does your company have any system to report the quality issues anonymously?
Some companies have a system to report the data integrity issues by the personnel without sharing their identity. But 38% of companies don't have implemented this system. It is not mandatory to have such a system but it can help to improve the data integrity in pharmaceutical companies.

Q6. Who has the administrator rights of the instruments like HPLC and GC?
The person having administrator rights of any computer or software can change or delete the data or change the date of the computer system. Analysts having administrator rights can analyze the sample in any that is the biggest data integrity violation. 14% of analysts and 35% of lab in-charge have administrator rights that are not good for a fair analysis. In 51% of companies, the IT personnel have administrator rights of the computers used in the analysis. It shows only 51 % of companies are following the right procedure for administrator rights.

Q7. Does your company have an efficient and qualified manpower?
When we asked this question, 10% responders admitted that their company doesn't have the efficient and qualified manpower. It means 10% of pharmaceutical companies are running without qualified personnel.

Q8. Does your company have data integrity issues that can be found in a regulatory inspection?
This question describes the overall condition of data integrity in pharmaceutical companies. 51% of survey responders admitted that their company has data integrity issues and these issues could be found in regulatory audits. It means more than half of companies have data integrity issues.

Results of this survey show that a lot of pharmaceutical industries are not serious about data integrity. A lot of data integrity issues are there in pharmaceutical manufacturing facilities. It is required to focus on these issues to manufacture the quality products that would be safe for the patients.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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