China Food and Drug Administration (CFDA) has released draft guidance on drug data management practices. The document is designed to help organizations involved in the development, production and distribution of pharmaceuticals to maintain accurate, timely and traceable data records.

The lengthy document covers everything from the need for senior management to cultivate a culture that values data integrity through to the technical aspects systems need to meet CFDA’s standards. On an organizational level, CFDA is advocating for companies to have structures and procedures that identify risks to data integrity, as well as open and transparent cultures that encourage employees to come forward when they spot a problem. Companies must investigate potential violations in line with their deviation handling procedures, and report issues that affect quality and safety to CFDA.

CFDA seems aware this focus on data integrity may clash with other priorities at the companies it regulates. The agency states commercial, political, financial and organizational pressures must not affect work to ensure the reliability of data. The aforementioned quality culture is one of the ways CFDA thinks companies can achieve this goal. Other recommendations include allocating sufficient human and technical resources to the task and ensuring all staff involved with GXP are trained in data reliability.

The document also covers the establishment of systems that minimize the potential for individuals to compromise data integrity. CFDA wants companies to use signatures that support the identification of who created or modified data. In the case of modifications, the system should require changes to be approved and the reasons for the amendments to be logged. This requirement is part of a set of demands focused on traceability. If an existing computerized system falls short of CFDA’s audit trail requirements, the company must adopt alternative methods to comply with the regulation.

CFDA is accepting comments on the draft until the end of the month.

(SOURCE: RAPS)