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
Follow-up action
  • 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.