Self Inspection & Internal Audit

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Self Inspection & Internal Audit

 

1.0           Purpose

1.1            To describe the procedure of conducting self – inspections as a part of the quality assurance    system in order to monitor the implementation of current Good Manufacturing Practice (cGMP) in the site operations and to propose necessary corrective /preventive measures. It is an effective tool for ensuring compliance with relevant GMP and regulatory requirement. Records of such Self inspections and any subsequent corrective and preventive actions shall be maintained.  

2.0           Scope

2.1         Self inspection should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice (GMP) principles and to propose necessary corrective measures of  NAME Pharmaceuticals Ltd.

 

3.0           Responsibility

3.1            Head of Quality Assurance is responsible to ensure the training of the auditors responsible for Self-Inspection. 

3.2            Officer/Sr. Officer, QA is responsible to prepare annual Self-inspection Schedule, audit agenda, verify the action taken and prepare yearly review report.

3.3            Head of Quality Assurance is responsible to approve the audit schedule, constitution of audit

team and implementation of each audit schedule, provide guidance where required, approve  the action plan , close out the audit observations and approve the review reports.

3.4            Head of Quality Assurance or deputy is responsible to follow up of audit observations with corrective actions and preventive actions (CAPAs) and discuss in the quality management 

review meeting for the outstanding CAPAs.

3.5            Audit team members are responsible to carry out the audit and submit the audit report to QA .

3.6            Responsible persons for the action is to carry out the agreed corrective & preventive action within agreed time line & to provide documentary evidence to QA after action taken.  

 


4.0           Abbreviations and Definitions

4.1            Internal Audit: A systematic internal examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented and maintained effectively.

4.2            Critical observation: Any observation that directly affects the safety of products and is likely to result in an immediate or latent health risk to the recipient, or fraud misrepresentation or falsification of product(s) or data.

4.3            Major Observation: Any Observation that potentially affects the safety of the products and could result in an immediate or latent health risk to the recipient. Major observation is a major deviation   from the GMP regulations.

4.4            Minor observation: Any observation that neither critical nor major and has low or negligible impact on the safety of the product (s). Minor observation is a slight departure from the GMP regulations.

4.5            GMP:   Good Manufacturing Practices

 

5.0           Materials and Equipment

5.1            None

 

6.0           Precaution / Health and Safety Considerations

6.1            Wear the appropriate safety equipment & garments for each area to be audited.

6.2            Assign only qualified auditors to conduct self-inspections.

6.3            The personnel employed in an area should not be included in the audit team formed for auditing that area.

 

7.0           Procedure

7.1           Officer/Sr. Officer, QA will prepare annual Self-Inspection schedule covering Departments /           Sections which will be audited and take approval from Head of QA.

7.2           Fixed the Department /Section wise audit frequency as per following table –                 

Department / Section

 Audit Frequency

Warehouse

Twice in a year

Production

Twice in a year

Engineering

Twice in a year

Quality Control & Microbiology

Twice in a year

Quality Assurance

Twice in a year

Product Development

Twice in a year

Plant Admin & HR

Twice in a year

 

7.3           Share this approved annual Self-Inspection schedule to the respective department which will be audited.

7.4           Constitute a self-inspection team of at least 2 members. The team will include personnel not  employed in that area and will conduct the audit in an independent and detailed way by the qualified auditors. One of the team members will be from QA and  he / she will act as a lead  auditor responsible to lead the audit team (such as conduct opening meeting , auditing, wrap up  meeting, audits by external experts can also to be conducted for better compliance.

7.5           Audit team or QA shall prepare “Self-Inspection / Internal Audit Agenda” (Annexure-I) and inform the head of the respective department at least five days before the audit date.

7.6           QA will inform the respective department to be audited if it is not possible to conduct audit as per   the schedule. In that case carry out the audit within 10 working days from the scheduled date.

7.7           Audit team member circulate from the QA department.

7.8           Carry out an opening meeting with the audited at the beginning of the audit.

7.9           Review (audit team member) the previous inspection report of the respective department, outstanding CAPAs if any and during conducting the audit verify the follow up actions and implementation of CAPAs. Also review the current GMP requirements and other relevant guidelines for that particular Department/section.

7.10         Note down the observations made during the inspections in the audit note book and where applicable. Proposals for corrective / preventive measures. Ensure that all the check point in “CHECK LIST- SELF INSPECTION / INTERNAL AUDIT” (Annexure-IV).  

7.11         Perform a wrap up meeting at the end of each audit day informing all audit observation to the auditee. In the wrap up meeting both auditees and auditors will make clarification and agree the   observations noted during audit.

7.12       Prepare the “SELF INSPECTION/ INTERNAL AUDIT REPORT” (as per Annexure-II) assigning an audit reference number for each audit report abbreviation of Self inspection /specify the area or location /two numerical digit of serial number / last two numerical digit of the current year. e. g. SI/PR/01/24

7.13         List the number of the observations and categories the issues based on criticality of the audit findings (critical / major / minor) as mentioned in “SELF INSPECTION/ INTERNAL AUDIT   REPORT”

7.14         Audit team or QA will share the audit report with the respective departmental head within 3 working days to provide the action plans.

7.15         Respective department will provide the action plans of audit reports in the “AUDIT OBSERVATIONS AND ACTION PLANS” (Annexure-III.) with signature to QA Department  within 7 working days defining the corrective and preventive actions to be taken with  name / designation of the responsible person and the timeline.

7.16        Head of QA and Plant Manager are respectively approved and authorized the “AUDIT OBSERVATIONS AND ACTION PLANS” (Annexure-III.) within next 3 working days and share the report with the respective department to take action as agreed. Also fill up Annexure-III to handle     the CAPAs.

7.17         Enter each CAPA in the excel sheet as in the “Procedure for handling of CAPA plans and tracking  and put CAPA reference number.

7.18         Monitor (QA) all outstanding CAPAs to ensure satisfactory and timely completion of audit observation. if it is required for time extension (once) and /or review action the revised time line  and action should be agreed by the responsible person for the action and Head of QA.

7.19         Inform (Audited) QA along with supporting documents when the action has been taken.

7.20      Verify (QA) and close the action when it is reported as completed and update the status of each  action. Attach the evidence with the self-inspection form (Annexure-III.)

7.21         Arrange a quality management review meeting regarding the status of the completion of   CAPAs, the outstanding CAPAs and follow up effectiveness of the actions taken with the responsible area managers.

7.22       Prepare a annual and yearly review report of self-inspection covering the completion status of actions and outstanding CAPAs. Discuss in the quality management review meeting.

 

8.0           Reference Document

8.1         In-house

 

9.0           Annexure

9.1        Annexure-I          : Self Inspection / Internal Audit Agenda

9.2        Annexure-II         : Format of “SELF INSPECTION/ INTERNAL AUDIT REPORT”

9.3        Annexure-III        : Format of “AUDIT OBSERVATIONS AND ACTION PLANS”

9.4     Annexure-IV        : “CHECK LIST-SELF INSPECTION / INTERNAL AUDIT”

 


10.0        Revision History

 

Revision No.

Brief reason for the revision

   Effective Date

   Remarks

01

New

 

 



11.0        Training

11.1       Head of Quality Assurance or his nominee give the training of production operator and worker.

 

 


 

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