Internal Audit Plan as per GMP

.0 Purpose :This document describes the conduct of the Management review of the quality system for GM
Conformance Certification, including the conduct of an internal audit to assure the system meets t
requirements of ISO Guidelines and is effectively implemented..
2.0 Objective: To Provide Documented Procedure for review of the quality system for GMP Conformance Certificatio
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 a
gathers all information for the Management Review.
o QA Management Committee: Provides all information as required by the Board of Internal Audit a
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 :
 The QA Management Committee, by consensus, selects three qualified individuals for the Board
Internal Audit and Management Review Committee. Members to the Committee serve until they a
replaced.
 The Board of Internal Audit and Management Review Committee arranges for the half yearly intern
audit to be conducted.
 The date for the audit is established by mutual agreement between the Board of Internal Audit a
Management Review Committee and the General Manager Production and Asst. Manager Producti
(AMP).
 The audit is conducted by any member of the board or Internal auditor qualified to participate on t
Certification Board so long as the auditor is not a member of the QA Management Committee,
qualified and knowledgeable in certification, auditing.
 The audit must be conducted at least every 06 months.
 During the audit, personnel responsible for the area audited are immediately notified of the outcom
of the audit of their area.
 During an audit, it is possible that a difference of opinion can arise as to the severity of
observation. It is important not to spend too much time debating the merits of the observation. I
does not appear that the difference of opinion can be resolved, then the auditee should be inform
that the audit report is subject to review by the Board of Internal Audit and Management Revi
Committee and the QA Management
 The draft report is issued to the Board of Internal Audit and Management Review Committee with
14 calendar days. The Committee members review and comment on the report and a final report
issued.
 The final internal audit report is submitted to the QA Management Committee.
 The QA Management committee drafts a response to the audit report that is finalized after review:
 Findings, nonconformities, trends, and other opportunities for improvement are identified; investigat
to determine the causes; and corrective/preventive actions are developed. These actions a
implemented as soon as possible and recorded.
 The response to the internal audit report is submitted to the Board of Internal Audit and Manageme
Review Committee for their concurrence.
 Upon agreement on the response to the internal audit, the Board of Internal Audit and Manageme
Review Committee prepares a complete Certification Program Management Review Report th
includes, as appropriate,:
 Results of internal and external audits
 Feedback from clients and interested parties related to the fulfillment of the Certification Process
 Feedback concerning impartiality
 Follow-up actions from previous Certification Program Management Review Reports
 The status of corrective or preventive actions
 The fulfillment of objectives
 Changes that could effect the management system
 Appeals and complaints
 The Board of Internal Audit and Management Review Committee submit their Certification Progra
Management Review Report to the QA Management Committee.
 The Certification Program Management Review Report with the response to the internal audit
discussed at the next meeting of the full Board. The expected outputs of the review includes decisio
and actions related to:
 Improvement of the effectiveness of the management system and its processes.
 Resource needs.
 Decisions and actions of the Board are documented in the Board Minutes and all op
Corrective/Preventive Actions are reviewed and their status documented at all subsequent quarte
Board Meetings.
 Effectiveness of completed actions is reviewed at the next Program Management Review.
6.0 Abbreviations :
 GMP: Good Manufacturing Practice
 QA : Quality Assurance