Self inspection or internal quality audits or internal audits

1.0 OBJECTIVE

To lay down a procedure for conducting self Inspection.

2.0 SCOPE

This procedure is applicable to all the departments present in the XXX, Place

3.0 RESPONSIBILITY

3.1 Executive or above – To audit / execute compliance to audit findings /observations.

3.2 Department Head – To audit / review audit findings / observations and coordinate compliance to audit findings / observations, with other departments.

3.3 Head-QA– Plan and prepare audit schedule. Selection of Self inspection team.

4.0 PROCEDURE

4.1 Selection of Team for Self Audits

4.1.1 Self inspection team shall comprise of persons from various departments / Heads of the Departments. The auditors shall be choose from the departments other than the department to be audited.

4.2 Frequency of Self Audits

4.2.1 The Self audits shall be done on half yearly basis.

4.3 Planning for Self Audits

4.3.1 An ‘Self Inspection Plan’ shall be prepared as per Annexure-1 and Head-QA shall finalize the schedule of the audit in consultation to the other Heads of Departments.

4.4 Conducting the Self Audits

4.4.1 The self inspection shall be conducted for all departments. The audit schedule shall indicate the scope and shall be distributed to the respective department Heads.

4.4.2 The team of auditors shall use appropriate audit checklist, considering the scope of audit, requirements of the laid down systems, SOPs and observation of earlier audits, if any as per Annexure-3 to Annexure-8.

4.5 The Internal Audit shall not be confined to points mentioned in the checklist. The auditors may inspect all areas for compliance to cGMP, Regulatory requirements of Quality Assurance in totality.

4.6 Reporting of Findings shall be done as follows

4.6.1 The audit report comprising of agreed, finding based, factual evidences shall be prepared. It is necessary to record what, where and why the deficiency.

4.7 Following observations shall be treated as non-conformances, just to mention few-

4.7.1 No written instructions.

4.7.2 Failure to follow instructions-Improper training

4.7.3 Failure to label and sign on equipment's and materials

4.7.4 Improper cleaning & Documenting cleaning times

4.7.5 Bad personnel hygiene –Smokers, Tobacco & Gum chewers

4.7.6 Unauthorized document changes

4.7.7 Obsolete document not removed

4.7.8 Ineffective line clearances in Production & Packing

4.7.9 Ineffective corrective action

4.7.10 Un-calibrated equipment in use & Improper calibration documents

4.7.11 Overage (expired) product in storage

4.7.12 Repair operation not done

4.7.13 No documented evidence of the work

4.7.14 No calibration records

4.7.15 Bad record storage, back-up & Filling procedures

4.7.16 Bad and incomplete reconciliation statements of all materials

4.7.17 Outdated Environmental monitoring procedures & untimely recording

4.7.18 Non-compliance of regulatory requirements.

4.8 The observations shall be categorized by Head-QA as follows

4.8.1 Major – Observation has significant impact on product quality and / or safety and likely to have serious and / or harmful effect on the patient (e.g. Product mix up, Label mix up, adverse drug reaction)

4.8.2 Moderate – Observations other than critical, that is likely to result in a failure or reduction in suitability of use of a unit for its intended purpose (e.g. Reduction in potency, change in disintegration time, dissolution, broken tablets, particle counts in vials, sterilization failures etc.)

4.8.3 Minor- Observation that is not likely to feasibility of the unit of product for its intended purpose or departure from established standards having little bearing on the effective use or operation of the unit (e.g. Missing tablets/ capsules, smudging of over printed matter, missing blisters, missing cartons etc.).

4.9 The findings shall be summarized, after completion of self inspection by auditors, to the Head of the concerned department, and shall be reported and classified as major, moderate and minor in Annexure-2.

4.10 Head-QA shall review and send Self Audit report to all the concerned Heads of departments.

4.11 Corrective Action

4.11.1 If required the Head of department shall consult the Heads of other department about the corrective action plan and Target Completion Date.

4.11.2 The compliance of the audit observation shall be submitted to the Head-QA by the respective departments on or before the target completion date, for the follow up audit.

4.12 Follow Up Audit and Closing of Observations

4.12.1 On receipt of compliance report from the auditee, the concerned auditor shall verify the compliance report with respect to the target completion date.

4.12.2 After being satisfied with corrective & preventive actions, the auditor shall close the non-conformance.

5.0 ABBREVIATIONS

5.1 QA-Quality assurance

6.0 ANNEXURE

6.1 Annexure-1: Self inspection plan

6.2 Annexure-2: Audit findings

6.3 Annexure-3: Quality Assurance Check List

6.4 Annexure-4: Quality Control Check List

6.5 Annexure-5: Production Check List

6.6 Annexure-6: Warehouse Check List

6.7 Annexure-7: Utilities Check List

6.8 Annexure-8: Administration Check List