SOP For self inspection for GMP compliance is described in this post which you can follow in the section of the Quality Assurance Department.
OBJECTIVE
- To identify the role of self-inspection in the Quality Management System.
- To review the way in which a self-inspection program should be carried out.
- To discuss what to inspect and verify in a company’s self-inspection system
SCOPE
- The program should,
- cover all the premises of company
- be designed to detect shortcomings in the implementation of GMP
- recommend corrective actions
- set a timeframe for corrective action to be completed
RESPONSIBILITY
Manager Quality Assurance
PRINCIPLE
- The program should,
- Performed routinely
- Also on special occasions such as;
- Recalls
- Repeated rejections
- The procedure for self-inspection should be documented and there should be an effective follow-up Program.
- The team responsible for self-inspection should consist of personnel who can evaluate the implementation of GMP objectively; all recommendations for corrective action should be implemented.
- It can also be a good training exercise to involve operators in the process.
- The informal self-inspection that takes place on a daily basis is carried out by operators and managers. If something is seen to be wrong, it is immediately put right.
- The formal self-inspection process that takes place on a regular basis. The purpose of this is to take a step back from the day-to-day activities to review for compliance to GMP and to look for ways in which the system can be improved. There may also be a need to conduct self-inspections as a result of a specific problem such as frequent rejections.
ITEMS FOR SELF INSPECTION
There should be written instructions for self-inspection detailing what is to be inspected and at what frequency.
It should be used to ensure that a consistent approach is achieved.
The areas to be inspected will include:
- GMP
- Premises
- Warehouse
- Hazardous material store
- Packing area
- Production
- Sterile Manufacturing areas
- Optical check room
- Quality Control
- Micro lab
- Distillation plant
- Cafeteria
- Personnel
CARRYING OUT A SELF INSPECTION
Report prepared at completion of inspection, including:
- Results
- Evaluation
- Conclusions
- Recommended corrective measures
- Effective follow-up program
- Company management to evaluate both the report and corrective actions
- This report should be issued as quickly as possible. It does not need to be an elaborate, wordy document that no one will read. A simple list of findings with recommendations for corrective action is sufficient. However, it is important that responsibility for action and a timeframe are agreed, either during the inspection or soon after the report is issued.
FREQUENCY
Self-inspection will be carried out once in each quarter by two Duty Officers nominated by QAM through administration department.
PROCEDURE
- The self-inspection team is appointed by QAM and is comprising of officers from various departments as ‘Duty Officers’ for 3 working days.
- It is important that the team members are encouraged to be objective in their evaluation.
- Self-inspection team should consist of personnel who:
- can evaluate the situation objectively
- have no conflict of interest, have no revenge in mind
- should have experience as observers of a self-inspection team before becoming a team member
- The duly completed Performa should be submitted to the administration department within 3 working days.
- QAM administration will check that the Performa is duly filled in and then forward to QAM.
- It will be reviewed by QAM and will assign the responsibility for corrective action with a target date.
- It will then be circulated to the concerned HOD for the corrective action through AM administration.
- The concerned HOD will ensure that necessary corrective actions are completed within due date.
- HOD will verify the status of completed action by signing in the relevant column and return to QAM.
- QAM will finally verify that recommended corrective actions have been taken to address the highlighted problems.
- However if it is not possible within target date, it must be explained by respective HOD/QAM.
- Filled Performa will be reviewed by Plant Manager. Highlighted issues will be discussed for corrective & preventive actions.
- The record/Performa complete in all respects will be filed in the QAD.
Tags:
QA SOP