Sop for internal audit

OBJECTIVE:To enumerate the guidelines to be considered for conducting an internal Audit. It is carried out for self assessment and thereby improving the quality and standard of the products.

SCOPE:This SOP describes the guidelines for conducting internal audits of various departments.

REFERENCE:

NA

RESPONSIBILITY:Quality systems manager/QA executive to conduct the audits

Departmental HOD/executive for compliances.

DISTRIBUTION:

QA department

ABBREVATIONS:

SOP: Standard Operating Procedure

QA: Quality assurance

HOD: Head of the department

PROCEDURE:

1. Audit team and its functions –

1.1 Internal audit must be conducted to have a check on the functions of various Departments of the organization.

1.2 Internal Audit Team : – Auditors should have minimum qualification of B.Sc or B.Pharm.

1.3 The members of internal audit team are as follows –

1) Q.A. Executives 2) Production Executives 3) Stores Executive 4) Q.C. Executive

5) Product development executive

1.4 Functions: –

1.4.1 They must check compliance of the system with written procedures.

1.4.2 They must check Environmental assessment.

1.4.3 They must ensure whether various regular checks are being carried out for the production of tablets.

1.4.4 They must also check documentation of related activities by all departments.

1.4.5 They must check compliance with relevant Good Manufacturing Practice standards.

2. The factors to be covered by auditors are as under –

2.1 Building and Premises covering Production, QA and Stores –

2.1.1 Check the walls of building for cracks, holes and integrity.

2.1.2 Check the cleanliness and maintenance in the premises covering Manufacturing Area, Packing, Quality Assurance and Stores.

2.1.3 Check that all the things are properly, neatly kept and appropriately labeled.

2.1.4 Observe whether people follow proper hygienic rules in the factory.

2.1.5 Check for leakages from service lines like water, steam, compressed air etc.

2.2 Process –

2.2.1 Check that the work is carried out as per GMP procedures.

2.3 Area and Process Validation –

2.3.1 Check that the calibration of every measuring device and equipment is carried out at the scheduled frequency.

Confirm that the area is validated for specific functions and all the processes are validated.

2.4 Documentation

2.4.1 Check the documents of every process, calibration of equipments and validation of the processes pertaining to each department.

3. Prepare a detailed audit report of the areas audited with respect to observation, recommendations/rating.

4. Conduct the compliance audit within a stipulated period for the action taken of concerned departments. Maintain the records.

5. Sign the audit report and submit to the management.

6. Quality Rating System:-

Quality rating should be given as follows

No. Rating Interpretation

1 Excellent Item/area/system/knowledge is superior.

2 Adequate Item/area/system/knowledge meets basic minimum. requirements

3 Poor Item/area/system/knowledge is weak and not of acceptable standard

4 Unsatisfactory Item/area/system/knowledge is missing or of such nature to warrant serious quality/ compliance concerns.

FREQUENCY:

Once in 6 months.

FORMATS:

Format 1 – Senior Management Commitment

Format 2 – The Product Safety Plan – HACCP

Format 3 – Product Safety and Quality Management System

Format 4 – Site Standards

Format 5 – Product Control

Format 6 – Process Control

Format 7 – Personnel

Format 8 – Internal Audit Schedule