close-up of a young koala bear (Phascolarctos cinereus) on a tree eating eucalypt leaves.

Data Integrity: A View from Down Under

Following the lead of many of the world’s pharmaceutical regulatory agencies, on April 6, 2017, the Australian Therapeutic Goods Administration (TGA) released a Data Management and Data Integrity (DMDI) policy statement. TGA states that the policy “serves to provide some clarification regarding the TGA’s official position regarding DMDI practices for industry,” but at the same time noting that, “the requirements for data management and data integrity are not new and have been embedded in GMP requirements for a number of decades.”  The Policy also indicates that, as a PIC/S member, the TGA intends to reference the August 2016 PIC/S Data Integrity Guidance document, “when performing inspections of manufacturers and, where relevant, in reviewing approval submissions to TGA.

The Policy statement describes the following specific recommended areas of focus for pharmaceutical manufacturers, with regards to data management and data integrity:

  1. Review existing quality system procedures and systems to ensure data integrity is maintained.

Manufacturers are encouraged to focus on:

  • Control of hardcopy documentation and batch records, including the control and use of blank forms and templates.
  • Processes for the access, generation, control, and review of electronic data and audit trails
  • Validation of electronic systems
  • Systems for storage, back-up, and archiving of GMP data
  • Staff training and awareness of data integrity requirements
  1. Ongoing review of effectiveness of data integrity controls through self-inspection/internal audit programs
  2. Review data integrity controls at key service providers through supplier management and audit programs

 

The final specific direction provided by TGA indicates that when gaps are identified, it is TGA’s expectation that a firm’s quality systems, equipment, and software will need to be updated to address the concerns identified.

The full text of the TGA Policy can be found here.

For further information on the topic of data management and data integrity in the pharmaceutical industry and the importance of taking a proactive approach, please contact James Davidson, Ph.D. at j.davidson@lachmanconsultants.com.