Internal Audit SOP

Self-Inspection or Internal Audit Management

The Internal Audit or Self-Inspections Program helps to ensure the compliance with all relevant GMP and Regulatory Requirement.
Therefore this SOP defines the procedure and responsibility for the Self-inspection planning, implementation and follow-up to assure Site’s compliance with regulatory, cGMP and Site quality procedures.

The scope of such Self-Inspection Program encompasses all current Good Pharmaceutical Manufacturing Practice (cGMP) and Good Distribution Practices (GDP) topics including Information Systems and/or Computerized Systems and related Quality Management System Controls (e.g. compliance with SOPs, the applicable QA system used, change control, etc.).

The Self-inspection program also takes into account the need to review any recurrent quality system issues identified through non-conformance reporting.