In the pharmaceutical industry, data is everything because data is a proof of work. Batch manufacturing records and raw data ensure that pharmaceutical products are safe, effective and of high quality. Data integrity is the assurance that data is complete, consistent and accurate. Regulatory agencies found that data integrity issues are the most critical concerns in pharmaceutical industry.
In the past decade, regulatory agencies like FDA, MHRA, EMA and WHO identified that data integrity is a major compliance issue in regulatory inspections. In this post, we will explore why data integrity is so important for repertory agencies and how pharmaceutical companies can ensure data integrity compliance.
Legible – Is data readable clearly?
Contemporaneous – Is data recorded at the time of the activity?
Original – Is the data a first record or a certified true copy?
Accurate – Is the data correct and truthful?
The “+” includes:
Complete – Is data complete, including any repeat or reanalysis performed?
Consistent – Is data in chronological order and timestamps?
Enduring – Is data recorded in a permanent medium?
Available – Is data easily accessible for review?
Regulatory agencies always check data submitted by pharmaceutical companies to approve new drugs, evaluate a facility or investigate any adverse event and don’t have any other source to identify the reliability of a product or process. Here’s why data integrity matters so much for regulatory agencies.
These cases show that data integrity issues are not just administrative lapses but they are serious GMP violations. Companies must work to improve data integrity by providing training to all personnel and evaluation of their GMP understanding time to time.
Pharmaceutical companies must take data integrity as a core quality requirement, not just a compliance checklist. They can achieve it easily by using right systems, employee training and commitment to quality manufacturing. If you have any quality issues in your organization, you can contact us at any time.
In the past decade, regulatory agencies like FDA, MHRA, EMA and WHO identified that data integrity is a major compliance issue in regulatory inspections. In this post, we will explore why data integrity is so important for repertory agencies and how pharmaceutical companies can ensure data integrity compliance.
What is Data Integrity?
Data integrity is the maintenance and assurance of accuracy, completeness, consistency and reliability of data used in pharmaceutical industry. These rules are applied on both paper-based and electronic records. Regulatory agencies require data in pharmaceuticals to follow the ALCOA+ principles.ALCOA+ Principles
Attributable – Attributable defines that who performed the work and when.Legible – Is data readable clearly?
Contemporaneous – Is data recorded at the time of the activity?
Original – Is the data a first record or a certified true copy?
Accurate – Is the data correct and truthful?
The “+” includes:
Complete – Is data complete, including any repeat or reanalysis performed?
Consistent – Is data in chronological order and timestamps?
Enduring – Is data recorded in a permanent medium?
Available – Is data easily accessible for review?
Why is Data Integrity so Important for Regulatory Agencies?
Regulatory agencies always check data submitted by pharmaceutical companies to approve new drugs, evaluate a facility or investigate any adverse event and don’t have any other source to identify the reliability of a product or process. Here’s why data integrity matters so much for regulatory agencies. 1. Patient Safety
Falsified or manipulated data may lead to the release of an unsafe drug product into the market. This can harm the patients consuming the unsafe medicines and mission of regulatory bodies to protect public health may be compromised.2. Product Quality
Accurate data is essential to demonstrate that manufacturing and quality control processes are under control. Data integrity issues show problems with product quality like contamination, incorrect dosages or stability failure.3. Regulatory Decision-Making
Regulatory agency depends on honest data to evaluate product influence inspections and post market surveillance. Any data integrity issue creates doubt on the reliability of an organization and its entire system.4. Global Harmonization
As pharmaceutical products are supplied throughout the world in this situation data integrity ensures that the standards are similar across the world and facilities. It creates trust between different regulatory agencies.Common Data Integrity Issues Found by Regulatory Agencies
A lot of pharmaceutical companies fail to meet the data integrity principles. Regulatory agencies frequently found following data integrity issues.- Backdated entries or altered records
- Missing raw data or test results
- Unauthorized access to computer systems
- Uncontrolled worksheets or unofficial logbooks
- Lack of audit trails in electronic systems
- Failure to save data permanently
- Testing to compliance – repeating tests until a passing result is achieved
- FDA Form 483 observations
- Warning letters
- Import alerts or product recalls
- Suspension of manufacturing licenses
Global Regulatory Guidance on Data Integrity
Due to critical issues found on data integrity in pharmaceutical industry various agencies have published detailed guidelines on data integrity.- FDA (U.S.): “Data Integrity and Compliance with cGMP” (2018)
- MHRA (UK): “GxP Data Integrity Guidance and Definitions” (2018)
- WHO: “Guidance on Good Data and Record Management Practices”
- PIC/S: “Good Practices for Data Management and Integrity”
How can Companies Ensure Data Integrity?
Regulatory expectations are very high and pharmaceutical companies must build a culture of data integrity to meet these expectations.1. Strong Quality Culture
A quality culture should be developed to encourage honesty and transparency and avoid data manipulation. Ownership and accountability of the data should be defined.2. Employee Training
Train all employees on ALCOA+ principles and data handling procedures. Training assessment must be done to ensure that personnel understand the consequences of poor integrity.3. Documented Procedures
Documented procedures must be available defining how data is recorded, reviewed and retained. It should cover both paper and electronic records.4. Access Control and Audit Trails
Implement a role-based access to the computerized systems where everyone will run instrument with their username and password so that every action can be traced. Audit trails must be enabled for all computerized systems and they must be reviewed periodically.5. Data Review and Oversight
Implement independent QA review for critical data and audit trials of equipment. Internal audits should be conducted routinely to assess data integrity compliance.6. Validated Systems
All computer systems must be validated for their accuracy and data security. Implement a backup schedule to ensure data backup and recovery.Case Examples of Regulatory Action
FDA Warning Letters
In several big companies the FDA found that the companies deleted failing results and reanalyzed the sample to report passing values. These data integrity issues lead to warning letters, import alerts and product recalls.MHRA Findings
In various companies MHRA inspectors identified uncontrolled paper records and lack of data integrity, especially in microbiology laboratories.These cases show that data integrity issues are not just administrative lapses but they are serious GMP violations. Companies must work to improve data integrity by providing training to all personnel and evaluation of their GMP understanding time to time.
Pharmaceutical companies must take data integrity as a core quality requirement, not just a compliance checklist. They can achieve it easily by using right systems, employee training and commitment to quality manufacturing. If you have any quality issues in your organization, you can contact us at any time.
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