Inspection for self inspection program

1.0         Purpose     :       To provide instruction for Self Inspection program.

2.0         Objective  :        To provide a documented procedure for Self Inspection program.

3.0          Scope     :            This procedure is applicable for self-inspection program.

4.0         Responsibility   :

·              Primary: Officer – QA / Officer-Store

·              Secondary: Officer – QA Manager.

5.0       Procedure   :

·        Routine inspection

Ø           A trained Quality Assurance person(s) takes routine visit to processing area for the monitoring of routine production activities.

Ø           Following area / activities shall be covered in routine inspection.

Ø           Cleanliness of area / equipment / personnel etc.

Ø           Identification on equipment/containers /rooms.

Ø           Calibration of equipments /instruments.

Ø           Processing area for processing activity.

Ø           Filling Batch Manufacturing Records.

Ø           Reference to design procedures, specification, and test procedures, standard operating procedure.

Ø           Hygiene practices for handling of equipments /products.

Ø           In case of any discrepancy observed note down the observations in book and take the initial of concerned area in-charge for acknowledge. In the case of major discrepancy inform to Quality Assurance Head and respective Department Head for immediate action.

Ø           Quality Assurance department in consultation with other concern department shall decide the course of action.

·        Scheduled for Audit

Ø           Audit schedule shall be made by Quality Assurance Department concerned with other department Heads.

·        Audit Team

Ø           Audit team shall be made from local staff, expertise and knowledgeable in their field of activity and familiar with GMP.

Ø           An expert from outside other than local staff but in the same organization familiar with the GMP requirements and expertise may be appointed.

Ø           The team shall notify the auditors’ 10 days prior to audit to ensure routine work is well organized and planned.

Ø           A member of the audit cannot audit his own area of activity.

Ø           The audit team can call for all such relevant records, inspect sites, operation interact with people cutting across hierarchy to place factual position for management review and action.

Ø           Audit team can break up in 2 or more team and carry out inspection separately.

Ø           Department wise separate audit checklist shall be prepared.

Ø           Findings and observation report in writing should be clear, unambiguous and with facts and reference.

Ø           The approach of the self-audit team shall be such that information is willingly volunteered and open.

·        Audit Frequency  :

Ø           Two Times in a Year.

·        Audit Checklist.

Ø           Separate audit checklist shall be made for each department, e.g. Production, Maintenance, Stores, and Quality Control.

·        Inspection Report

Ø           Audit report shall be made by QA with coordination of other team members.

Ø           Audit report should mention.

Ø           Audit observations.

Ø           Suggestion for corrective action.

Ø           Name of responsible personnel who will take the corrective action of respective department.

Ø           The audit report shall be given to each of the section(s), concerning their activity   the plant manager shall receive the copy.

Ø           Discuss the findings with auditee or concerned department head.

Ø           All the audit team members are required to revert with their audit report.

Ø           In case major deviation observed in auditing a deviation analysis need to be conducted.

Ø           A copy of deviation analysis report is submitted to plant Manager

Ø           Submit the report to Quality Assurance. Quality Assurance to log the self-inspection report in sequential log.

Ø           Co-ordinate with Dept. being audited for corrective and preventive action.

Ø           Based on findings prepare summary of preventive and corrective action plan by Quality Assurance In-Charge.

Ø           If preventive actions are of long term, appoint a person for the follow up of Preventive action.

Ø           Review the results of preventive actions.

Ø           Close the self-inspection report as per the closure checklist.

6.0      Reference Document  :

v     Audit schedule

v     Audit team

v     Audit Checklists (Production, Stores, Maintenance & QC)

v     Audit report format

v     Audit compliances format

v     Audit closure format

7.0      Abbreviations   :

·          QA   = Quality Assurance department

·          SOP = Standard Operating Procedure

·        GMP = Good Manufacturing Practices

8.0      Copies to  Distribution Sites  :

·        QA

·        QC

·        Stores

·        Production

·        Engineering

·        Personnel & Administration