SOP For Self Inspection for GMP Compliance

SOP For self inspection for GMP compliance is described in this post which you can follow in the section of the Quality Assurance Department.


  • 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


  • 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


Manager Quality Assurance


  • 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.


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           


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.


Self-inspection will be carried out once in each quarter by two Duty Officers nominated by QAM through administration department.


  • 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.

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