Standard Operating Procedure for Audit and Inspection of Equipment
1) Purpose
The purpose of this SOP is to establish procedures for conducting audits and inspections of equipment used in the manufacturing of dental dosage forms, ensuring compliance with regulatory requirements, and identifying opportunities for continuous improvement.
2) Scope
This SOP applies to the audit and inspection activities conducted for all equipment used in the production, testing, and control of dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Quality Assurance (QA) Department is responsible for planning, conducting, and documenting audits and inspections. Production supervisors, engineering personnel, and operators are responsible for cooperating with auditors and ensuring equipment readiness.
4) Procedure
4.1 Audit Planning
4.1.1 Identify equipment to be audited based on risk assessment, regulatory requirements, and audit schedule.
4.1.2 Develop an audit plan outlining objectives, scope, criteria, and audit methods for each equipment audit.
4.2 Conducting Audits
4.2.1 Conduct thorough audits of equipment to verify compliance with standard operating procedures (SOPs), regulatory requirements, and manufacturer’s specifications.
4.2.2 Review documentation, records, and logbooks to ensure completeness, accuracy, and adherence to Good Manufacturing Practices (GMP).
4.3 Inspection and Testing
4.3.1 Perform physical inspections of equipment to assess cleanliness, functionality, and overall condition.
4.3.2 Conduct testing, if necessary, to verify equipment performance and accuracy.
4.4 Reporting and Corrective Actions
4.4.1 Document audit and inspection findings, including observations, deviations, and non-conformances.
4.4.2 Initiate corrective and preventive actions (CAPAs) to address identified deficiencies and ensure timely resolution.
4.5 Follow-up and Review
4.5.1 Monitor and track implementation of CAPAs to verify effectiveness and closure of audit findings.
4.5.2 Review audit reports and findings with relevant stakeholders to promote continuous improvement and compliance.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
GMP – Good Manufacturing Practices
CAPA – Corrective and Preventive Action
6) Documents, if any
Audit Plans
Audit Checklists
Audit Reports
CAPA Reports
7) Reference, if any
Regulatory guidelines for equipment audits and inspections
Company-specific audit and inspection protocols
8) SOP Version
Version 1.0
