STANDARD OPERATING PROCEDURE
|Procedure For Internal Facility Audit
- To lay down the procedure for carrying out Self Inspection of various departments.
- This procedure is applicable for carrying out the self inspection of all departments.
- It is a joint responsibility of all self-inspection team members in coordination with Quality Assurance.
Internal Facility audits shall be conducted in order to:
- Monitor the implementation and compliance with current Good Manufacturing Practice principles.
- To monitor the adherence to Standard Operating Procedures (SOP’s).
- To propose necessary corrective measures.
- To improve the awareness and responsibilities of personnel.
- Audit team
- The internal audit team will have at least the following persons.
- Manager-Quality Assurance or his nominee.
- Manager or supervisor of the department other than that being inspected.
- Manager or supervisor of the department being inspected.
- An external consultant may be included in the audit team at the discretion of the VP-Plant & Operations.
- Frequency of Self Inspection
- Self Inspection shall be conducted twice in a year (preferably conduct the self inspection in the first quarter and last quarter of the year).
- The self-inspection shall cover all aspects of quality systems and current regulatory requirements.
- Self-inspections shall be performed for all activities / areas of Production, Quality Control, Quality Assurance, Warehouse, Engineering & Utility, Personnel & Administration departments.
- Unscheduled audits may be carried out at the discretion of VP-Plant & Operations.
- Schedule of Self Inspection
- Quality Assurance is responsible for conducting the self inspection at defined intervals.
- Executive – Quality Assurance shall prepare a detailed self inspection schedule including audit team, date, and time of audit, audit site, auditors & audited as per format.
- Self inspection schedule is approved by VP-Plant & Operations and is circulated to the entire relevant department at least three days before the inspection.
- Conduct the inspection in a professional manner, recording all observations, together as per the Self Inspection checklist.
- During Self Inspection, relevant supporting documents shall be verified for compliance.
- After the completion of self inspection, all the team members along with Manager- Quality Assurance shall discuss and finalize the deficiencies observed during the audit.
- Deficiencies shall be categorized as follows:
- Minor – Having no significant impact on product quality and/or safety.
- Major – Having significant impact on product quality and/or safety.
- Critical – Having significant impact on product quality and/or safety and likely to have a serious and a harmful affect on the patient.
- Executive – Quality Assurance will prepare a summary of the deficiencies and other observations made during the inspection and will be approved by Manager – Quality Assurance.
- The approved Self Inspection Report (Department wise) as per the format shall be prepared within 72 hours from the date of inspection and circulated to the concerned department head.
- In the event of a critical deficiency being identified, senior management must be immediately informed and production of the relevant product(s) must be halted until such time as appropriate corrective action has been taken. The possibility of recall of the products affected must be considered.
- Department heads are responsible for preparing the Proposed Corrective Action Report for the deficiencies reported within a time frame of 48 hours from the receipt of self inspection report and submit to Quality Assurance as per the format.
- If the Critical deficiency has observed, Manager-Quality Assurance shall finally prepare a Conclusion Report of Self Inspection and submit to the VP-Plant & Operations as per the format.
- The conclusion report shall include a brief note on deficiency, the proposed corrective action, evaluation comments and recommendations.
- The Conclusion Report shall be prepared and submitted to management at the earliest from the receipt of proposed corrective action report.
- A Follow up inspection date shall be recommended to monitor the proposed corrective action and its implementation.
- Self inspection conclusion report shall also indicate the proposed follow up inspection date & due date for next self Inspection.
- Manager–Quality Assurance or his nominee along with the concerned department head shall be responsible for verifying the implementation of corrective action during the follow up inspection.
- Compliance to the proposed corrective action shall be verified and assured during the follow up inspection.
- All self inspection documentation are archived in Quality Assurance department
Note: Self inspection Report and follow-up inspection reports are confidential documents and are not auditable.
SOP – Standard Operating Procedure
QA – Quality Assurance
- DISTRIBUTION LIST
|Quality Control – Microbiology
|Production – Tablet Section (General)
|Production – Liquid Section (General)
|Production – Capsule Section (General)
|Production – Powder Section (General)
|Production – Tablet Section (Beta-Lactum)
|Production – Powder Section (Beta-Lactum)
|Production – Capsule Section (Beta-Lactum)
|Engineering & Utility
|Personnel & Administration
|VP-Plant & Operations