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 the 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.
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