Learn how to conduct the self inspection and quality audits in Pharmaceuticals.
1. Introduction:Self inspection is basically a method of objective overall review of one’s own operation on aspects that may have on quality effect on quality assurance. In general, self inspection aims at identifying defects whether of critical, major or minor nature. Self inspection should be conducted by designated competent persons from the company. Self inspection program is conducted in order to monitor the implementation and compliance with current GMP principles and to ensure that the necessary corrective measures are taken.
2. Purpose:Self inspection is a way to evaluate the whole operating system from every aspect that might influence the quality of the products. It is not only to find the weakness or fault but more important is to find a way to prevent and to overcome the problems effectively.
3. Team of Self inspection:A self inspection team, of which the members are appointed by company management, should initially prepare a self inspection check list for reference in the implementation of inspection. Self inspection team should be withdrawn among the production, quality control, quality assurance, research & development, engineering and general affairs departments. The team should consist of technically competent persons with high conscience in quality assurance in drug product processing activities.
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.
Premises and Equipment
Storage of starting and finished products
Production and in-process controls
Sanitation and Hygiene
Validation and revalidation program
Product complaint and recall
Calibration of instruments
Results of previous self inspection and corrective action taken
Also see: cGMP Guidelines for Pharmaceutical Industries Part 1 and cGMP Guidelines for Pharmaceutical Industries Part 2
5. 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 check list
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 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
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
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