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1. Introduction:
Self-inspection is essentially a method of objective overall review of one’s operation on aspects that may have a quality impact on quality assurance. In general, self-inspection aims to identify defects that are critical, major or minor in nature. Self-inspection should be carried out by qualified persons nominated by the company. Self-inspection programs are conducted to monitor implementation and compliance with current GMP policies and to ensure that necessary corrective actions are taken.
2. Purpose:
Self-inspection is a way to evaluate the entire operating system in every aspect that can affect product quality. Not only finding weaknesses or faults but more importantly finding ways to prevent and overcome problems effectively.
3. Self-Inspection Group:
A self-inspection team, whose members are appointed by the company’s management, should initially prepare a self-inspection checklist for reference in carrying out the inspection. Self-inspection teams should be withdrawn from production, quality control, quality assurance, research and development, engineering and general affairs departments. The team should include technically competent persons with high conscientiousness in quality assurance in drug product processing operations.
4. Coverage of Self-inspection:
The Self-inspection team should carefully study every point in the GMP guidelines and drive questionnaires fitted to the company needs. The following items should undergo self-inspection so as to ensure GMPs in the premises as per WHO requirement.
Personnel
Premises and Equipment
Maintenance
Storage of starting and finished products
Production and in-process controls
Quality control
Documentation
Sanitation and Hygiene
Validation and revalidation program
Distribution
Product complain and recall
Calibration of instruments
Labels control
Results of previous self-inspection and corrective action is taken
5. The frequency of Self-inspection:
Self-inspection shall be conducted at reasonable intervals but should cover an area/operation/function at least once a year or if necessary at short intervals.
6. Procedure:
Prepare a time schedule and area to be self-inspected
Determine the Self-inspection team
Prepare a Self-inspection checklist
Record all filling
Prepare the finding report and recommendations
Distribute to the Department Head concerned
Prepare a corrective action plan
7. Self-inspection Report:
In the implementation of self-inspection, the team should consistently bear in mind that the purpose of the self-inspection is to look for improvement and not only fault finding. The team also gives recommendations for solving encountered problems taking into consideration the economic aspects of GMP implementation.
8. Distribution of Report:
Plant Director
Production Manager
Quality Control Manager
Head of Engineering Dept.
9. Corrective Action:
Should be appropriate to correct deficiency
Must prevent re-occurrence
Must be completed in a timely manner
It should be documented and records maintained
Must be monitored
