Draft PIC/S Good Practices for Data Management and Integrity

PIC/S has published on a draft basis a guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Draft 2)) developed by the PIC/S Working Group on Data Integrity. This draft guidance will be applied on a 6-month trial basis by PIC/S Participating Authorities. This draft document results from the need among Inspectorates to have access to harmonised data integrity guidance, considering the impact to public health. The purpose of the trial-period is to learn from implementation. It is acknowledged that the guidance requires expanding in some areas; however, the document has value in describing foundational principles which can be enhanced in future revisions. This draft document is not open for comments by industry. Formal adoption of the guidance will proceed in accordance with PIC/S procedures – including a stakeholders’ consultation – on a revised version after completion of the trial-period.

Download: PI_041_1_Draft_2_Guidance_on_Data_Integrity_2

A new number: 8400!!

Current Warning Letter:

FDA found 8,400 unofficial chromatographic analyses at the Desano plant performed between 2012 and 2014. The company has acknowledged that some of those tests related to out-of-spec test results.

The FDA was also disturbed by finding many electronic logs of production deviations in a folder titled “GMP Anomalies” that had never been investigated.

Read more (external link)

Risk-Based Environmental Monitoring White Paper

Environmental Monitoring (EM) programs for pharmaceutical manufacturing are evolving to a risk-based approach. The use of sampling data for the identification and mitigation of risk becomes a critical element in this process. No longer is it enough to utilize data for reactive excursion reporting. The case study provided in this white paper highlights the need for automated EM software systems to analyze large amounts of data and recognize risks before a problem occurs.

REDUCE RISK (Download White Paper)

US-FDA Guidance for Industry Data Integrity and Compliance (DRAFT)

The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212. Part 210 covers 1Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of  Drugs; General; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography Drugs. This guidance provides the Agency’s current thinking on the creation and handling of data in accordance with CGMP requirements.

Download at fda,gov:

Data Integrity and Compliance With CGMP