Lee Sullivan on the truth about data integrity in pharmaceutical manufacturing
The US Food and Drug Administration (FDA) has long emphasised the importance of reliable data in pharmaceutical manufacturing. Despite this clear recommendation, recent FDA reports have highlighted an increase in data integrity violations during several recent current Good Manufacturing Practice (cGMP) inspections. Here we explore three data integrity pitfalls to which pharmaceutical manufacturers are most vulnerable.
In simple terms, cGMP states that pharmaceutical manufacturers should follow instructions and document actions correctly, so that if any deviation occurs in the product, the company can investigate it and put measures in place so that the same error does not happen again. This guarantees the repeatability and safety of the product being manufactured and protects the brand.
Data integrity refers to the completeness, consistency and accuracy of data, which needs to be attributable and legible. Data integrity violations can lead to warning letters and even fines. More importantly, drugs approved on the back of inaccurate data could pose a threat to patients’ lives. For all these reasons and more, data integrity is at the heart of the pharmaceutical records discussion.
Audit trails
The pharmaceutical industry has been slowly transitioning from manual paper records to often automated, electronic records. Batch records predominantly take an electronic form today, but other systems, including production processes, such as start-ups, changeovers, running documentation and sampling, are not always digitalised. Although paper records can work well for some companies, they leave more room for human error and data manipulation than their electronic counterparts.
The true benefits of digital records become obvious when companies use reliable HMI/SCADA software that automatically records the actions each user carries out. The software also makes data manipulation impossible; once a user inputs data, the action is saved automatically. If the input is wrong, the system records the error and the user is required to leave a comment in order to continue with production.
Another advantage of using HMI software for electronic records is that the system can be set up so that the user can’t start or finish a batch without filling in a minimal amount of information. This means there are no more gaps in the records, which in turn improves data accuracy.
Finally, HMI/SCADA software can automatically log any critical event and allows users to set alarms or notifications should any of the pre-defined values exceed set parameters. This ensures that any deviation in the process is identified in real-time, automatically shared with relevant members of staff and recorded for the audit trails.
The login dilemma
The best way to ensure precise data integrity is to assign individual logins on a per user basis. There are several ways of achieving this; a common method is to assign each operator an individual username and password. Other secure reliable methods could be using Active Directory logins or personal cards with a scannable bar code. With individual user login enabled, the system can record any action or change made by an operator, thus offering a clear picture of the overall process. Individual logins also increase a system's security at no additional costs, as they allow a company to attribute different authorisation levels to users.
Data safety
Another common concern of pharma companies is data safety – how does a manufacturer know its production data is safe and cannot be manipulated?
By using reliable HMI/SCADA software, companies can help eliminate this issue. When exporting archives to an external database, for example, the software uses its internal mechanisms to check whether the data has been correctly and completely transferred. If the transfer fails for some reason, the software will automatically resend the transfer next time it starts a cycle, so data is never lost or corrupted. The software will also log the incident chronologically in the events list.
To ensure data safety, the software stores critical data such as audit trails and alarm lists in binary files – which are illegible to the human eye - in a proprietary format. Authorised users can modify data within the software, but the modification will always be logged in the audit trail. This practice ensures the archive is accessible, easy to read and accurate for authorised users, while also adding an additional layer of protection against unauthorised access.
The benefits of using electronic records in pharmaceutical manufacturing go beyond regulatory compliance. Looking to the future, companies who strive for continuous improvement can use electronic records to achieve this business goal.
By integrating the HMI/SCADA software into a top level ERP system, pharmaceutical manufacturers can identify potential areas for savings, such as a decrease in energy consumption and raw material wastage. Companies can go one step further and reduce, or even eliminate, unplanned downtime by applying predictive maintenance. It also allows manufacturers to free up the staff that traditionally record data manually and better employ their skills elsewhere in the business.
Digital records that guarantee data integrity and safety allow companies to breeze through regulatory compliance and focus on improving and growing their business, comfortably complying with the FDA and cGMP.
Lee Sullivan is with Copa-Data UK.
