SOP on Internal quality Audit in Pharmaceutical industry

Purpose:

To describe the procedure for internal quality audit to ensure implementation of cGMP and regulatory in to the premises

Scope:

This procedure is applicable all concern department where audit need to be performed.

  Responsibility:

  QA:           To prepare the audit schedule and planning of the audit

To issue required format to the auditors for preparation of audit reports and audit findings.

 Auditee:    Keep all documents easily available for auditor.  

 Auditor:    To perform fair and effective audit concern department

QA head:   To ensure activities, implementation & compliance of nonconformance.

                 To review and effective implementation of CAPA after completion of Audit

 

Procedure:

-Internal Quality System Audit shall be performed to complies cGMP requirement and effectiveness of all activity and the documentation done into the factory premises.

-The purpose of the audit is to verify the compliance of laid down quality systems and identification of areas that require focus and compliance in pharma industry. 

-Following are the different department into the pharmaceutical company where audit shall be performed (not limited to).

Store

Production

QC
Quality assurance

Microbiology

Engineering

HR

Dispatch  

-Audit schedule shall be prepared and audit shall be conducted in different department as per plan. If any deviation in audit plans it shall be recorded in audit plan schedule as remark.

-Auditor team shall be decided by QA before preparation of the audit schedule. 

-Auditors should be from the different of the department being audited.

-Audit team comprises of one team leader and other are team members. 

-Audit schedule content the audit date, in which department audit to be performed and name of the auditee and auditors.

-Internal Quality System Audit schedule shall be distributed to all concern departments before 03 days.

According to audit schedule audit shall be performed.

- Auditor shall be included following check point during Audit activity performed as per SOP, Any deviation during, review of filled documents and records ,previous audit compliance report etc.

-During Audit the effectiveness of completion of corrective and preventive action from the previous audit shall be verified.

-All observations/deviation/non-conformance observed during audit shall be documented in Internal Quality Audit Check List & Observation sheets.

All the observations are classifying as Critical, Major & Minor.

Critical observation:

The condition will seriously affect Product Quality/Patient Safety Related deficiency.The condition violates cGMP – rules and quality assurance practices.

Major observation:

The condition may affect the Significant cGMP Deficiency but with no direct impact on Product Quality /Patient Safety

Minor observation: 

The condition may not affect GMP deficiencies that are either considered to be minor isolated examples or there is insufficient information.

-All the observations / deviations/ non-conformances shall be discussed with the concerned department and documented.

-All observation and non-conformance shall be reviewed by the auditor and documented properly.

-Audit compliance report shall be prepared by the auditor.

-Head QA shall review the audit report and distributed to concern department.

 

-If any critical /major non conformance found it require the immediate corrective and preventive action.

-Auditee shall ensure that the proposed corrective action is implemented during specified time period.

-If required additional audit shall be carried out. Minimum two audits in a year shall be carried out.