1. A systematic inspection program to detect any short comings in the implementation of cGMP and to recommend necessary corrective actions.
  2. Manager QA/Head QA shall nominate the Self Inspection team.
  3. Team shall be a cross functional team comprising of persons from different departments such as Quality Assurance, Quality Control, Production, Warehouse, Engineering and Personnel and Administration department. QA must be a part of the team.
  4. Internal auditor shall be trained with Auditor Certification Training program.
  5. Educational Qualification:- Graduate in Science, Pharmacy, Engineering and other respective disciplines.
  6. Experience:- Preferably 5 years of experience in pharmaceutical industry, GMP knowledge, professional and practical experience related to GMP. Understanding of National, Local and Global legislation GMP.
  7. Designate QA person shall prepare a schedule (for the next year) at the end of the calendar year. The frequencies for audit shall be scheduled as twice in a year
  8. The actual audit date may vary by ± 15 working days from the tentative date or depend on the availability of Audit team.
  9. The Self Inspection team shall summarise the audit observations and discuss the observations among the team members.
  10. The team shall classify the audit observations as Critical, Major or Minor based on following.
  11. The concerned HOD shall submit the response within 10 working days of receipt of “Self-Inspection observation report” which includes compliance to audit observations, action plan for CAPA with target completion date.
  12. The self-audit team members shall review the compliance report and verify the implementation as stated in the compliance report.
  13. On verification of implementation, the self-audit team members shall close the report and submit the report along with Audit summary to Head – QA.
  14. Head – QA/ Designee shall review and ensure that the observation reports are closed properly. Designated person from QA shall store the report in documentation cell for 6 years.

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Reference links:-

http://apps.who.int/medicinedocs/en/d/Js5517e/20.4.8.2.html

http://pharmapathway.com/sop-internal-audit-self-inspection/