- The FDA has released new guidance aimed at helping drug manufacturers ensure data integrity and product safety.
The document is an update to the FDA’s 2016 draft guidance on the topic and will ensure industry compliance with current good manufacturing practice (CGMP).
The new recommendations will help drug manufacturers identify lapses in data integrity, implement best practices, and ensure consistent commitment to data quality and accuracy.
“Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
“Overseeing the quality and safety of pharmaceutical manufacturing is key to these efforts. Having clear guidelines for companies on how to prevent product quality issues is an important step to protecting patient safety and preventing drug shortages of critical medicines.”
A key way companies can ensure product quality and patient safety is to create work cultures that emphasize the importance of data integrity and promote data integrity as a core value, Gottlieb stated. Establishing a work environment where employees are encouraged to promptly identify and report data issues will help enhance the value of products.
“We expect all manufacturers to conduct timely and appropriate investigations of suspected problems, including expanding the scope beyond the narrow problem first observed into any other potentially impacted data, batches, or products,” Gottlieb said.
“Pharmaceutical quality can only be assured by robust quality control, which includes vigilant oversight of data integrity.”
The FDA also recommended that all data created as part of a CGMP record should be evaluated for quality and maintained for CGMP purposes.
“Manufacturers must ensure that original laboratory records, including paper and electronic records, are subject to second-person review to make certain that all test results and associated information are appropriately reported,” the agency said.
Additionally, if companies want to invalidate a CGMP test result, the FDA stated that they will need a valid, documented, and scientifically sound justification for doing so. The organization also suggested that manufacturers ensure only authorized personnel can change CGMP records and laboratory data.
“To assist in controlling access, it is important that manufacturers establish and implement a method for documenting authorized personnel’s access privileges for each CGMP computer system in use (e.g., by maintaining a list of authorized individuals),” the FDA wrote.
Manufacturers should also assign system administrator roles to individuals who are independent from those responsible for the record content, as system administrators are permitted to alter files and settings.
The agency warned against companies sharing computer login credentials among multiple employees, which would make it difficult to trace any data modifications to a single individual. Manufacturers should also document or save all data that is generated to satisfy a CGMP record.
“FDA expects processes to be designed so that data required to be created and maintained cannot be modified without a record of the modification,” the organization stated. “It is not acceptable to store electronic records in a manner that allows for manipulation without creating a permanent record.”
These new recommendations build on the FDA’s commitment to improve data integrity. In recent years, the FDA has increased its efforts to prevent and uncover data integrity issues, Gottlieb noted, and has trained staff to identify and voice concerns related to data integrity. The revised document will build on these policies and improve patient safety.
“Over the past decade, we’ve uncovered situations in which drug quality data and information are not accurate,” Gottlieb said.
“Sometimes, data integrity concerns are a result of deceptive practices. But more commonly, they’re a result of inadequate processes and systems to ensure reliable and accurate data. In all cases, we regard any lapse in data integrity as a risk to patient safety. Patients can’t be assured of the safety and effectiveness of their medication when data has been altered.”
In addition to the new guidance, the FDA has used a pre-approval inspection process to help ensure data integrity by evaluating the proper handling and storage of data. The agency also conducts thorough assessments of applications prior to approval, and of manufacturing process changes.
The FDA has also expanded its partnerships with international regulatory agencies, which allows the FDA to regularly exchange information about quality and data integrity violations in facilities around the world. This communication helps the FDA advance best practices on data security and integrity.
The new guidance will help promote the FDA’s past efforts to improve data integrity, as well as enhance patient safety and product development in the future.
“Our goal is to ensure that the data associated with drug manufacturing are complete, consistent, and accurate, and therefore reliable,” Gottlieb concluded. “This new guidance is one part of our multi-layered approach to ensuring the integrity of data.”