1. Purpose
The purpose of this document is to provide some requirements as well as some recommendations for the development, content and management of Compliance Improvement Plans (CIPs).
2. Scope and Applicability
This guideline is applicable to all manufacturing functions, departments, or marketing companies undertaking work, or providing support services, required to meet Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and/or International Organization for Standardization (ISO) standards.
3. Definitions
3.1 Management
It is the responsibility of the management of each function, department, manufacturing site or marketing company to regularly monitor the compliance status of their operations. Management should generate a Compliance Improvement Plan (CIP) as a result of their review. Quality Risk Management should be applied to priorities any improvement areas identified.
3.2 QA Managers
QA Managers, IS Quality Managers shall ensure that the CIP is generated, maintained and regularly reviewed.
3.3 Individuals
The individual responsible for completion of each issue should be identified within the plan.
4. Guideline
4.1 Establishment of Compliance Improvement Plan
A CIP must be established and maintained as an outcome of the management review process of compliance issues and status. It is recommended that the CIP be a separate document, however, there may be alternate ways to capture and manage the necessary information.
4.2 Areas to Review for Compliance Improvement
Management review of compliance status and for input to the CIP may include:
– Quality and Compliance Objectives
– Quality and Compliance Manual – Standards, Procedures and Guidelines
– Applicable external regulations and guidelines
– Inspection and Audit observations and responses
– Compliance Management Group Information and Action Bulletins
– Quality and Compliance Key Performance Indicators (KPI)
– Adverse trends
– Corrective and Preventive Actions (CAPAs)
– Customer Complaints, Deviations or errors
Where areas for improvement are identified, Quality Risk Management should be used to priorities items for including in the CIP.
4.3 Contents of Compliance Improvement Plan
Some recommended key components for the content of the plan are (see also Appendix 1):
– Task/improvement area
– Priority of the action (e.g., high, medium or low or numeric designation 1, 2, 3)
– Nature of improvement required
– The responsible person
– Progression status
– Comments
– Date completed
– Additional explanatory information
4.4 Review of Compliance Improvement Plan & Action Completion
Compliance Improvement Plans must be reviewed regularly. This should be done on at least a quarterly basis.
Plans should be reviewed by senior management at the site or in the function that is covered by the plan.
Key achievements may need to be reported in the Annual Compliance Assessment (ACA) process.
4.5 Reporting of Key Performance Indicators (KPIs) and/or Issues
Significant issues related to GXP and KPIs should be reported to Quality and Compliance Management Team.
Each report should be reviewed to see if issues should be added to the CIP. In a similar way, items on the CIP that are not being completed on time may need to be included in the issues report.