Self Inspection Procedure

Self inspection procedure is verification of effective implementation of the Quality Management System in adherence to cGMP requirements including planning and to suggest corrective and preventive actions where required. This procedure is undertaking review of various approved systems and documents by appointed team members. 

1. Quality unit shall nominate a self-inspection team from site staff preferably  departmental heads and/ or immediate subordinates catering to a specific area shall be nominated to Self Inspection, the selection of the self-inspection team ensures that the personnel are trained for self inspection by means of education, training, overall job experience and awareness of Quality management systems
2. Self Inspection of each and every department shall be carried out at least twice in year. this is called planned self-inspection, additional inspection shall also be conducted in case of major non-conformance or GMP failure, product failure, and market complaint and before major external inspection as decided by quality unit is called unscheduled self-inspection. 
3. Self-inspection may be planned every year in December, to succeeding year and same has been approved by Quality unit. This schedule is circulated to all members of self-inspection team and all internal department heads.
4. During self inspection following to be covered but not limited to:

• Organization and personnel
• Building and facilities
• Equipment
• Components and material including containers and closures
• Production and process control
• Packaging and labeling controls
• Holding and distribution
• Laboratory controls
• Records and reports
• Returned and salvage drug products
• Quality Management System
• Material Management System
• Training and Qualification of Personnel
• Quality Control
• Documentation
• Sanitation and Hygiene
• Validation or re-validation schedules
• Calibration of instruments or measurement systems
• Recall procedures
• Results of previous self-inspections and any corrective steps taken
• Any other area determined by Head-Quality

Conduction of the audit: Quality unit is responsible for all audit arrangements, preparations, conduct, reporting and compliance monitoring towards corrective actions, self inspection shall be conducted as per a predetermined audit schedule and on the basis of checkpoints mentioned in self inspection checklist of respective department.

Inspection team member shall review the reports of the previous self inspection, prior to start inspection the audit team shall audit individual departments for compliance , inspection shall not be restricted to the checklist but the checklist shall serve as a reference point for self inspection.

After completion of self-inspection, report shall be prepared with categorization of deficiencies / observations. The auditee department shall receive the inspection report within seven days of completion of audit. The categorization of deficiencies shall be as follows:

• Critical Deficiency / Observation: A deficiency or an observation, which leads to or has significant risk of producing or distributing a product that is harmful to consumers. This type of deficiency requires thorough investigation and correction action on immediate basis.
• Major Deficiency / Observation: A deficiency, which indicates a major deviation from GMP and / or written procedures and indicates failure to carry out satisfactory release of batches. This type of deficiency requires time bound correction and preventive action and its completion.
• Minor Deficiency/Observation: A deficiency, which cannot be classified as either critical or major but indicates a departure from GMP and / or written procedures or other relevant requirements. This type of deficiency must be addressed to avoid the recurrence of such deficiencies.

Based on the category of deficiency / observation, HOD of the auditee department shall prepare a corrective action report, covering the action taken and / or planned with target completion date and shall forward to Quality unit within 15 days from the date of report of audit. The complete compliance to the self inspection report shall be submitted within 30 working days from the date of receipt of self inspection report by audittee department. If the compliance to any particular observation require more than specified time interval of 30 days the reason for the same shall be intimated to quality unit.

self-inspection team members shall verify the compliance and severity of deficiency, and shall decide  follow up audit is required or not, and same shall be intimated to auditee department.