Internal Audit and Self Inspection
Objective : To lay down a procedure for periodic internal audit and self inspection, to ensure current Good Manufacturing Practices compliance.
Scope : This Standard Operating Procedure is applicable to all departments of all formulation plants of Panacea Biotec Limited.
Responsibility :
Audit Team : Auditing the facility and to prepare audit report comprising of recommendations and corrective action necessary for respective
Auditee Head :Head of the audited department, to ensure access is provided to internal audit team to the department and relevant documents required by internal audit team. He or she shall also ensure that corrective actions are taken within a specified time frame as mentioned in the internal audit report.
Head-QA : Audit team constitution, audit schedule approval and distribution of Audit Report. Head-QA shall also ensure the compliance to the
Abbreviations and Definitions
Internal Audit : An onsite verification of activity used to determine effective implementation of documented quality systems.
Self-Inspection: Verification of departmental activity used to determine effective implementation of documented quality systems.
Audit: Word represents both Internal Audit and Self Inspection.
Auditor: A person who has the technical qualification or is trained or the experience to perform audits.
Auditee: A department to be audited.
Procedure
Audit shall be carried out at two levels. Self inspection and Internal Audit.
Self Inspection is done at departmental level i.e. representative of department shall perform inspection of all the documents and activities done by the department. Self Inspection shall be conducted once in every two months. The Self Inspection shall have ±7 day’s acceptable tolerance and inspection shall be done within this period. These representatives shall be nominated as auditors by the Department Head and shall have direct reporting to department head. An audit report shall be prepared and corrective and preventive action shall be determined, filed and Periodic Internal Audit shall be carried out by an Executive(s) of QA & / or by an audit team constituted by head QA in all operational departments. While selecting a team member for audit team the head QA shall ensure that the member is not from the same department for which audit is to be carried out.
Internal Audit shall be carried out as per the schedule prepared by QA department/Management. The month and department to be audited shall be mentioned in the internal audit planner, which shall be prepared for a calendar year. This Internal audit planner shall be circulated to concerned department by Head-QA, preferably in the month of January of every calendar year. The actual dates of audit shall be proposed by QA before executing the audit.
Quality Assurance shall mark the upper half box in red colour for planned date and the auditee department shall mark the lower half box in green colour against the planned date as per their suitability.
The internal audit planner shall be distributed in triplicates, one copy each for planned date from QA and the agreed date from the user department and one for QA department for execution reference.
The Internal audit shall have ±7 days acceptable tolerance and Audit shall be done within this period.
If internal audit of any particular department / activity is required towards the investigation/ addressing of the product complaint or product recall the same shall be performed any time.
Internal audit may also be conducted before the inspection of any regulatory body.
During the audit, auditors shall use the checklists for each department, but the scope of audit may not be restricted to the checklist only. In checklist under the ‘Remarks’ column, the auditor shall mention whether the observation is adequate or inadequate.
The audit team shall evaluate systems, processes, and functions of the department to ascertain current level of the cGMP. The audit team shall check for the compliance for the various procedures, raw data and record the findings in “Internal Audit/Self Inspection Report”.
The Auditor shall assign a seven character number as ‘AAXX/YY’ in consultation with QA to Audit report where;
AA : Denotes the type of Audit i.e. For Internal Audit ‘AA’ shall be represented as (IA) ,For Self Inspection ‘AA’ shall be represented as (SI)
XX : Denotes respective serial number of Audit.
YY : Denotes respective year of the Audit.
e.g. Second Internal Audit of the year 2025 shall be numbered as IA02/25and third self inspection audit in the month of March in the year 2025 shall be represented as SI03/25.
A new series of Audit report No. shall commence at the beginning of every calendar year.
Observation made during the audit shall be discussed with the concerned in-charge of the concerned department and / or the head of the department. Depending on the nature of the findings and the risk associated with any non-compliance, the following classifications shall be used:
Critical: – Deficiencies which have a high probability of causing adverse consequences to the patient or consumer or may result in significant deviations in the safety, identity, strength or purity of the product; or are a combination of major deficiencies which indicates a critical system failure.
Major: – Deficiency which could potentially cause adverse consequences to the patient or consumer if left un-addressed could be considered indicative of poor control or are a combination of minor deficiencies which indicate a major system failure.
Minor: – A deficiency which cannot be classified as critical or major. It also includes a deficiency which is not related to GMP or regulatory conformance requirement(e.g. EHS ), but warrant attention by the auditee.
Good Practice: – Demonstration of exemplary achievement of compliance or setting a precedent within the current industry standard.
Upon completion of the audit, audit team shall compile the audit report comprising of recommendations, which shall be forwarded to respective department head for corrective action and tentative date for compliance. For Internal audit this audit report shall be send through Head-QA.
A register shall be maintained for self inspection by the department auditors and for Internal audit by QA regarding issuance of audit report to concerned department Head.
For Internal audit reports concerned department head shall mention corrective action plan and tentative date for compliance based upon audit observations and shall send back the Audit Report within 15 working days of receipt of internal Audit report to QA.
Upon receiving back the internal audit report, Head-QA or his /her designee shall review internal-audit report and shall verify the corrective action taken. If required, a follow-up audit shall be carried out by any member of audit team. A review status of corrective action taken shall be mentioned in the respective column of Internal Audit Report. A copy of report compiled by the audit team shall be forwarded to concerned department for final action and compliance.
If required, Head- QA shall discuss the action plans with the respective department head.
If Internal Audit Report compliance is not received by QA within specified time limit of 15 working days, a reminder(s) shall be sent to concerned department head. A copy of this reminder(s) shall be attached with Internal Audit Report.
Finally Head -QA shall notify Head Quality& Compliance about the critical audit findings & corrective action proposed / taken by the Auditee.
Results of previous internal audits shall be reviewed again during the next Internal Audit where no corrective action was taken.
Audit Planning and audit execution process are delineated in the “Flow chart for Internal Audit” for guidance .
Note:–The contents of the audit reports generated following this SOP are confidential and revelations of the observations in the audit reports to external auditors shall be at the discretion of Head Quality Assurance.