UK Regulator Issues Updated Guidance on Data Integrity

To ensure data integrity, drugmakers should implement data controls in their manufacturing processes aligned with the risk to product quality, the Medicines and Healthcare products Regulatory Agency says.

The system should be fully documented with supporting rationale, and designed in a way that encourages compliances, the MHRA says in updated guidance on data integrity.

For example, staff should have access to clocks for recording timed events and access to batch records at the locations where activities occur so that ad hoc data recording and later transcription to official records isn’t needed, the agency explains.

Access controls should be in place to ensure that employees have access only to data and systems appropriate for their job role. Shared logins or generic user access should not be used, and access should be restricted to the minimum number of people, the agency says, adding that people with a direct interest in the data should be denied access to the system.

Paper or Electronic Records

The data integrity requirements apply equally to paper and electronic data, the guidance says. If primary data is recorded at the same time by multiple systems, the system that generates and stores the data needs to be defined, the guidance says.

The defined primary records need to be as accurate, complete and relevant as possible. Print of manual records should not be named the primary record if electronic records are available.

The guidance defines a “true copy” of an original recording as the exact verified copy. The copy may be either static — e.g., paper or a noneditable PDF file — or dynamic — e.g., an interactive electronic record. Critical data should be stored in dynamic form so regulatory investigators can access detailed information.

Audit trails record GMP critical data and should include data relevant to the reconstruction of a process or activity. Audit trail review should be part of the routine review and approval process. Data review procedures should be in place and all reviews must be documented.

The guidance is intended to complement existing EU good manufacturing practice requirements relating to active substances and dosage forms.

A single integrity issue calls into question all the data produced by a company. Investigators are already citing an increasing number of manufacturers for data integrity failures. In 2014, 13 of 18 GMP warning letters focused on data integrity violations. Don’t leave anything to chance. Get FDAnews’ Data Integrity Compliance today.