SOP for Self Inspection and Internal Audits : Pharmaceutical Guidelines

SOP for Self Inspection and Internal Audits

Standard operating procedure to plan and conduct self inspection and internal audits in pharmaceutical manufacturing facilities.

1.0 OBJECTIVE

To define a procedure for systemic examination of quality systems and processes to verify compliance with applicable regulatory requirements.

2.0 SCOPE

This procedure is applicable to the internal quality audit carried out in the various departments.

3.0 RESPONSIBILITIES

QA Executive/ QA Officer

4.0 ACCOUNTABILITY

QA Head/ QA Manager

5.0 PROCEDURE

5.1 Audit Plan: Initiate for the audit by filling up the audit plan form. A filled audit plan form shall be circulated to auditors, auditee and quality/Factory head. Mention the details as explained below.
5.1.1 Audit Objective: Write audit objective in this column. Audits objective may be but not limited to one or more of the following.
5.1.1.1 To determine the conformity or nonconformity of the quality system elements with specified requirements.
5.1.1.2 To determine the effectiveness of the implemented quality system in meeting specified quality objectives.
5.1.1.3 To meet regulatory requirements.
5.1.1.4 To evaluate an organization’s own system against cGMP.
5.1.2 Audit Scope: Write the scope of the audit program. The scope and depth of the audit shall be designed to meet the audit objective. The standards or documents with which the auditee’s system is required to comply may be specified. The scope may cover one or more of the following.
5.1.2.1 Quality system elements.
5.1.2.2 Organizational Activities.
5.1.2.3 Standard Operating Procedures.
5.1.2.4 Good manufacturing practices / Good Laboratory Practices.
5.1.2.5 Documentation.
5.1.3 Auditee:
5.1.3.1 Write the name of the department/ section which is to be audited.
5.1.4 Audit Team (Auditors):
5.1.4.1 Write the name and department of the auditors who shall conduct the audit.
5.1.4.2 The audits shall be conducted by, but not limited to a member of Quality Assurance.
5.1.4.3 The auditor or audit team shall prepare a checklist for the audit.
5.1.4.4 The auditors or audit team shall plan the audit, prepare working documents and coordinate with other auditors of the audit team.
5.1.5 Audit Schedule:
5.1.5.1 Write the date, duration and place of the audit.
5.2 Executing the Audit:
5.2.1 While performing an audit, the auditor shall consider following.
5.2.1.1 Auditors shall report critical nonconformities to the auditee or audit team immediately.
5.2.1.2 Auditors shall exercise objectivity.
5.2.2 Collecting Evidence:
5.2.2.1 Evidence shall be collected through interviews, examination of documents, and observation of activities and conditions in the areas of concern.
5.2.2.2 Information gathered through interviews may be tested by acquiring the same information from other independent sources, such as physical observation, measurements and records.
5.2.3 Audit Observations:
5.2.3.1 All observations shall be documented.
5.2.3.2 After all activities have been audited, the audit team shall review all of their observations to determine which are to be reported as nonconformities. The audit team shall then ensure that these are documented in a clear concise manner and are supported by evidence.
5.2.3.3 Nonconformities shall be identified in terms of specific requirement of the standard or related documents against which the audit has been conducted.

5.3 Audit Report:
5.3.1 The Audit report shall contain but not limited to the following items, as applicable.
5.3.1.1 The objective and scope of the audit.
5.3.1.2 Details of the audit team members, auditee’s representative, and audit dates.
5.3.1.3 Documents audited.
5.3.1.4 Observations of nonconformity mentioning the details of Product name batch no., reference document no., page no., line no., date, and the name of the person, whichever is applicable.
5.3.1.5 The audit report distribution list.
5.3.2 Based on the observations the auditor shall prepare a report.
5.3.3 The audit report along with the observation shall be given to concerned department head for response with a copy to Quality Head and Plant Head within 15 days after the audit.
5.3.4 The QA department may issue a corrective action request for the pending observation.
5.4. Corrective Action:
5.4.1 The auditee is responsible for determining and initiating corrective action needed to correct the cause of non-conformity.
5.4.2 The auditee shall respond in writing to each observation, which shall include corrective action taken within 15 days after receipt of the audit report.
5.4.3 Corrective action request may be given. The target date for closing of the corrective action request shall be given in consultation with the auditee.
5.4.4 Follow up audit shall be done to confirm completion of pending corrective actions or to check the effectiveness of completed corrective action at the discretion of QA Head.
5.4.5 After all the recommendations are implemented, the QA department shall close the audit report.
5.5 Frequency: At least twice a year.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 QA: Quality Assurance
6.3 cGMP: Current Good Manufacturing Practices





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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