SOP for Internal Audit

1.0  Purpose    :   This document describes the conduct of the Management review of the quality system for GMP Conformance Certification, including the conduct of an internal audit to assure the system meets the requirements of ISO Guide and is effectively implemented..

2.0 Objective   :  To Provide Documented Procedure for review of the quality system for GMP Conformance Certification, including the conduct of an internal audit to assure the system meets the requirements.

3.0   Scope        :  To define role/responsibility of various functions responsible for Internal audit

4.0     Responsibility    :

o       Board of Internal Audit and Management Review Committee:  Arranges for the internal audit and gathers all information for the Management Review.

o       QA Management Committee:  Provides all information as required by the Board of Internal Audit and Management Review Committee and is responsible for follow-up corrective and preventive actions.

o       QA Internal Auditor(s):   Conduct the internal audit according to GMP.

5.0      Procedure   :

Ø      The QA Management Committee, by consensus, selects three qualified individuals for the Board of Internal Audit and Management Review Committee. Members to the Committee serve until they are replaced.

Ø      The Board of Internal Audit and Management Review Committee arranges for the annual internal audit to be conducted.

R     The date for the audit is established by mutual agreement between the Board of Internal Audit and Management Review Committee and the General Manager Production and Asst. Manager Production (AMP).

Ø      The audit is conducted by any member of the board or Internal auditor qualified to participate on the Certification Board so long as the auditor is not a member of the QA Management Committee, is qualified and knowledgeable in certification, auditing.

Ø      The audit must be conducted at least every 12 months.

Ø      During the audit, personnel responsible for the area audited are immediately notified of the outcome of the audit of their area.

R     During an audit, it is possible that a difference of opinion can arise as to the severity of an observation. It is important not to spend too much time debating the merits of the observation. If it does not appear that the difference of opinion can be resolved, then the auditee should be informed that the audit report is subject to review by the Board of Internal Audit and Management Review Committee and the QA Management

Ø      The draft report is issued to the Board of Internal Audit and Management Review Committee within 14 calendar days. The Committee members review and comment on the report and a final report is issued.

Ø      The final internal audit report is submitted to the QA Management Committee.

Ø      The QA Management committee drafts a response to the audit report that is finalized after review:

R     Findings, nonconformities, trends, and other opportunities for improvement are identified; investigated to determine the causes; and corrective/preventive actions are developed. These actions are implemented as soon as possible and recorded. 

Ø      The response to the internal audit report is submitted to the Board of Internal Audit and Management Review Committee for their concurrence.

Ø      Upon agreement on the response to the internal audit, the Board of Internal Audit and Management Review Committee prepares a complete Certification Program Management Review Report that includes, as appropriate,:

R     Results of internal and external audits

R     Feedback from clients and interested parties related to the fulfillment of the Certification Process

R     Feedback concerning impartiality

R     Follow-up actions from previous Certification Program Management Review Reports

R     The status of corrective or preventive actions

R     The fulfillment of objectives

R     Changes that could effect the management system

R     Appeals and complaints

Ø      The Board of Internal Audit and Management Review Committee submits their Certification Program Management Review Report to the QA Management Committee.

Ø      The Certification Program Management Review Report with the response to the internal audit is discussed at the next meeting of the full Board. The expected outputs of the review includes decisions and actions related to:

R     Improvement of the effectiveness of the management system and its processes.

R     Resource needs.

Ø      Decisions and actions of the Board are documented in the Board Minutes and all open Corrective/Preventive Actions are reviewed and their status documented at all subsequent quarterly Board Meetings.  

Ø      Effectiveness of completed actions is reviewed at the next Program Management Review.