- A systematic inspection program to detect any short comings in the implementation of cGMP and to recommend necessary corrective actions.
- Manager QA/Head QA shall nominate the Self Inspection team.
- 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.
- Internal auditor shall be trained with Auditor Certification Training program.
- Educational Qualification:- Graduate in Science, Pharmacy, Engineering and other respective disciplines.
- 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.
- 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
- The actual audit date may vary by ± 15 working days from the tentative date or depend on the availability of Audit team.
- The Self Inspection team shall summarise the audit observations and discuss the observations among the team members.
- The team shall classify the audit observations as Critical, Major or Minor based on following.
- 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.
- The self-audit team members shall review the compliance report and verify the implementation as stated in the compliance report.
- On verification of implementation, the self-audit team members shall close the report and submit the report along with Audit summary to Head – QA.
- 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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