Standard Operating Procedure (SOP)
Title: SOP on Internal Quality Audits / Self Inspection
SOP No.: xxxxxxxxxxxxxx / Page 1 of 3
Effective Date: xxxxxxx / Review Date: xxxxxxxx
Previous Version No.: Not applicable / New Version No.: 00
Originating Department: Quality Assurance
Distribution List: Quality Assurance, Quality Control, Production, Engineering, Warehouse, Purchase, HR, Validation and Administration

1.0Objective

To lay down a procedure for conducting Internal Quality Audits / Self Inspection.

2.0Scope

This procedure is applicable to unit of xxxxxxxxxxxx, located at xxxxxxxxxxx.

3.0Responsibility

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

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

3.3Head-QA/ nominee – Plan and prepare audit schedule. Selection of Internal audit team.

4.0Accountability

4.1Head – QA / Plant Head shall be accountable for compliance of the SOP.

5.0Procedure

5.1 Selection of Team for Internal Quality Audit;

5.1.1 Internal Quality Audit Team shall comprise of persons from various departments / Heads of the Departments. The auditors shall be chosen from the departments other than the department to be audited.

5.2Planning for Internal Quality Audit;

5.2.1An ‘Internal Quality Audit Plan’ shall be prepared as per annexure xxxxxxxxxxx and Head QA shall finalize the schedule of the audit in consultation to the other Heads of Departments.

5.2.2The Internal Quality Audit shall be conducted for all departments on half yearly basis. The audit schedule shall indicate the scope and shall be distributed to the Heads of the departments.

5.2.3The 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.

Prepared By / Date / Checked By / Date / Approved By / Date - QA
Standard Operating Procedure (SOP)
Title: SOP on Internal Quality Audits / Self Inspection
SOP No.: xxxxxxxxxxxxxx / Page 1 of 3
Effective Date: xxxxxxx / Review Date: xxxxxxxx
Previous Version No.: Not applicable / New Version No.: 00
Originating Department: Quality Assurance
Distribution List: Quality Assurance, Quality Control, Production, Engineering, Warehouse, Purchase, HR, Validation and Administration

5.2.4The 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.

5.3Reporting of findings shall be done as follows;

5.3.1The audit report comprising of agreed, finding based, factual evidences shall be prepared. It is necessary to record;

What was found?

Where it was found?

Why is it a deficiency?

5.4Following observations shall be treated as non-conformances, just to mention few-

No written instructions.

Failure to follow instructions-Improper training

Failure to label and sign on equipments and materials

Improper cleaning & Documenting cleaning times

Bad personnel hygiene –Smokers,Tobacco & Gum chewers

Unauthorized document changes

Obsolete document not removed

Ineffective line clearances in Production & Packing

Ineffective corrective action

Uncalibrated equipment in use & Improper calibration documents

Overage (expired) product in storage

Repair operation not done

No documented evidence of the work

No calibration records

Bad record storage, back-up & Filling procedures

Bad and incomplete reconciliation statements of all materials

Outdated Environmental monitoring procedures & untimely recording

Non-compliance of regulatory requirements.

5.4The observations shall be categorized by Head-QA as follows;

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)

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.)

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.).

5.5The findings shall be summarized, after completion of internal quality audit by auditors, to the HOD of the concerned department, and shall be reported and classified as major, moderate and minor in annexure xxxxxxxxxxxx.

5.6Head QA shall review and send Internal Quality Audit report to all the concerned Heads of department for compliance with intimation to the Plant Head.

5.7Corrective Action

5.7.1If required the Head of department shall consult the HOD of other department about the corrective action plan and Target Completion Date.

5.7.2The 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.

5.8Follow Up Audit and Closing of Observations;

5.8.1On receipt of compliance report from the auditee, the concerned auditor shall verify the compliance report with respect to the target completion date.

5.8.2After being satisfied with corrective & preventive actions, the auditor shall close the non-conformance.

6.0List of Annexure and Formats

S. No. / Format Title / Format
Number / Annexure
Number / No. of Pages
1 / Internal Quality Audit Plan / xxxxxxxx / xxxxxxxx / 1
2 / Audit Findings / xxxxxxxx / xxxxxxxxx / 1

7.0References

7.1SOP on SOPs.

8.0Reason for revision.

8.1Not applicable if it is first version.

Prepared By / Date / Checked By / Date / Approved By / Date - QA
xxxxxxxxxxxxx
SOP No.: / Version No.: 00 / Effective Date:
Format No.: / Effective Date: / Page 1 of 1
Annexure No.: / Page 1 of 1

Internal Quality Audit Plan

Month: ______Date: ______to ______

Scope of Audit: ______

Department / Area / Date / Time / Auditors / Specific Focus / Scope / Remarks

Prepared ByApproved By Executive QA Head QA Sign & Date Sign & Date

Prepared By / Date / Checked By / Date / Approved By / Date - QA
xxxxxxxxxxxx
SOP No.: / Version No.: 00 / Effective Date:
Format No.: / Effective Date: / Page 1 of 1
Annexure No.: / Page 1 of 1

Audit Findings

Department / Area: ______Date: ______

S. No. / Non Conformances / Observations / Target Completion Date
(by the auditee) / Remarks

Auditors: 1) ______2) ______3) ______

Sign & Date: 1) ______2) ______3) ______

Prepared By / Date / Checked By / Date / Approved By / Date - QA