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Self Inspection in Pharmaceutical Industry


A planned and systematic examination and check of a system, procedure or operation by Self-inspection in order to monitor compliance, the effectiveness of established standards, and to allow for improvement and corrective measures wherever required.

The Importance of self-inspection in pharmaceutical industry is to identify the non-compliance with respect to Manufacturing Practices of production, Quality Control systems, quality assurance procedures, engineering practices, environmental conditions etc., 

The self-inspection programme is intended to detect and analyze the observations and take the necessary actions. 


These inspections should be performed scheduled and unscheduled with SMEs, having knowledge with respect to the current regulatory requirements.

The inspection shall be conducted for all the departments in the manufacturing facility as per regulatory requirements at least once in year or every six months.

Self inspection can be initiated in case of emergencies where the product needs to be withdrawn from the market or recurrence of product failure in the facility or in case of pre notified regulatory inspection etc., 

The identified observations during audit should to be discussed during the closure meeting and further appropriate CAPA shall be proposed.

The inspection observations shall be discussed in quality review meetings till the closure of open observations and it's impact.

Self-inspection reference guidelines:

1. WHO Self-Inspection Annexure 3

2. Revised Schedule M 10. Self-inspection, quality audits and suppliers’ audits and approval

3. USFDA: Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations D. Evaluation Activities 2. Conduct Internal Audits

4. PIC/S Guide to Good Manufacturing Practice for Medicinal Products Part I CHAPTER 9 - SELF INSPECTION

5. TGA Interpretation - self inspection – chapter 9

6. EudraLex Vol 4, Chapter 9: Self Inspection

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Resource Person: Dr.Prasadhi Shiva

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