Both internal and external audits play a vital role in securing and maintaining a Drug Establishment Licence (DEL) in Canada, as they help ensure ongoing compliance with Good Manufacturing Practices (GMP) and applicable regulatory requirements.

Internal Audits (Self-Inspections)
Internal audits, also referred to as self-inspections, are carried out by the drug establishment’s quality assurance personnel or by an independent internal auditor.

Purpose: To systematically evaluate the organization’s systems, processes, and documentation against regulatory expectations and internal standards in order to identify deficiencies, reduce risk, and promote continuous improvement.

Requirement: Health Canada’s GMP guidelines mandate that self-inspections be conducted at regular intervals in accordance with an approved audit schedule.

Role in DEL: Routine internal audits support preparedness for external regulatory inspections by maintaining a state of audit readiness. All audit observations, along with corrective and preventive actions, must be properly documented and reviewed by management.