Data integrity PIC S

9.10 Management of Hybrid Systems .................................................................................... 52
10 DATA INTEGRITY CONSIDERATIONS FOR OUTSOURCED ACTIVITIES ................ 54
10.1 General supply chain considerations ............................................................................. 54
10.2 Routine document verification ........................................................................................ 54
10.3 Strategies for assessing data integrity in the supply chain ............................................ 54
11 REGULATORY ACTIONS IN RESPONSE TO DATA INTEGRITY FINDINGS ............ 56
11.1 Deficiency references ..................................................................................................... 56
11.2 Classification of deficiencies .......................................................................................... 57
12 REMEDIATION OF DATA INTEGRITY FAILURES ....................................................... 59
12.1 Responding to Significant Data Integrity issues ............................................................. 59
12.2 Indicators of improvement .............................................................................................. 60
13 Glossary ......................................................................................................................... 61
14 REVISION HISTORY ..................................................................................................... 63
1 DOCUMENT HISTORY
Adoption by Committee of PI 041-1 1 June 2021
Entry into force of PI 041-1 1 July 2021
2 INTRODUCTION
2.1 PIC/S Participating Authorities regularly undertake inspections of
manufacturers and distributors of Active Pharmaceutical Ingredient (API) and
medicinal products in order to determine the level of compliance with Good
Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
principles. These inspections are commonly performed on-site however may
be performed through the remote or off-site evaluation of documentary
evidence, in which case the limitations of remote review of data should be
considered.
2.2 The effectiveness of these inspection processes is determined by the
reliability of the evidence provided to the inspector and ultimately the integrity
of the underlying data. It is critical to the inspection process that inspectors
can determine and fully rely on the accuracy and completeness of evidence
and records presented to them.
2.3 Data management refers to all those activities performed during the handling
of data including but not limited to data policy, documentation, quality and
security. Good data management practices influence the quality of all data
generated and recorded by a manufacturer. These practices should ensure
that data is attributable, legible, contemporaneous, original, accurate,
complete, consistent, enduring, and available. While the main focus of this
document is in relation to GMP/GDP expectations, the principles herein
should also be considered in the wider context of good data management
such as data included in the registration dossier based on which API and
drug product control strategies and specifications are set.
PI 041-1 3 of 63 1 July 2021