- OBJECTIVE :
To provide a guideline for self-inspection of facility by a team of qualified persons to monitor the implementation and compliance with Good Manufacturing Practices and propose corrective actions.
This SOP is applicable for self-Inspection to all departments.
All Department Heads.
5.1 All the departments listed below shall be audited at least four times in a year.
5.1.1 Solid Orals Dept.
5.1.2 Liquid Orals Dept.
5.1.3 Liquid injection Dept.
5.1.4 Engineering Services & Utilities
5.1.6 Quality Control
5.1.7 Quality Assurance
5.1.8 Personnel & administration
5.2 An audit schedule indicating the month of the auditing each department shall be prepared at the beginning of the year.
5.3 Audit shall be conducted as per the schedule as far as possible.
5.4 Audit shall be done on a normal working day by the three member team comprising of member(s) of QA and other member(s) from following departments:
5.4.3 Quality Control
5.4.4 Ware House
5.4.5 The head of the department or his delegate being audited shall accompany the team during the audit as auditee.
5.5 Report of the last audit shall be referred & has to be confirmed for completion of pending compliance if any.
5.6 Audit shall be done as per the checklist for the individual departments provided but May not be restricted to the checklist. All the points in checklist may not be covered in every inspection.
5.7 Each observation(s) should be communicated to the departmental heads for immediate corrective actions where possible.
5.8 Any adverse observation shall be noted down during the audit and shall be discussed during summing up session at the end of the audit with the department head and the other concerned people in the department.
5.9 Quality Assurance shall prepare an audit report based on the observations recorded during the audit.
5.10 The audit report may include the suggestions to correct the adverse findings.
5.11 The audit report shall be sent to the Head of department audited with copies of Head of Operations within 15 days of completion of the audit.
5.12 Head of department audited shall submit the response to audit, which shall include the corrective actions taken or planned to correct the deficiencies, addressed in the audit report.
5.13 The response shall be submitted within 15 days from the date of audit report.
5.14 Quality Assurance Head shall verify completion of all the corrective actions after they are done and prepare a formal Audit Closure Report certifying the same.
Trainer : Head – Quality Assurance
Trainees: Staff of all the departments
Master Copy : Quality Assurance
Controlled Copy : Quality Assurance
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|SOP||Standard Operating Procedure|
11.0 REVISION HISTORY OF CHANGE
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