SOP for Preparation, Approval, Issue, Control, Uncontrol and Revision of Quality Manual : Pharmaceutical Guidelines

SOP for Preparation, Approval, Issue, Control, Uncontrol and Revision of Quality Manual

Standard operating procedure to prepare, approval, issue, control, uncontrol and revision of quality manual.

1.0 OBJECTIVE

To define the procedure for the preparation, approval, issue, control, uncontrol and revision of the quality manual.

2.0 SCOPE

This SOP covers the preparation, approval, revision and distribution of the QUALITY MANNUAL based on QUALITY MANAGEMENT SYSTEM REQUIREMENTS ISO 9001–2000.

3.0 RESPONSIBILITY

3.1 Doing: ASST. MANAGER (QC)
3.2 Checking: AGM. - QC

4.0 ACCOUNTABILITY

MANAGEMENT REPRESENTATIVE / VICE PRESIDENT (WORKS)

5.0 PROCEDURE

5.1 The Quality Manual is to be prepared to meet the requirements of ISO 9001 : 2000 Quality Management System with the help of ISO 9000-2000 Quality Management System : Fundamentals and Vocabulary and ISO 9004 : 2000 Quality Management : Guidelines for performance improvement.
5.2 Quality Manual should contain approved quality policy and measurable quality objectives.
5.3 Quality Manual can be made available on request by the controlled copy holders for reference to specified clients for information about the resources, methods and quality practices established and maintained by the organization in meeting their specified requirements.
5.6 Quality Manual, which is revised every two years and updated, is a controlled version and the one, which cannot be updated or revised, is an uncontrolled version.
5.7 Distribution list for controlled copies of Quality Manual, which can be revised are maintained as per the list is shown in the quality manual itself.
5.8 The copies of the quality manual can be provided with the approval of the management representative to any agency not covered in the distribution list. Such copies of the quality manual are not subject to revision and these are labeled as uncontrolled copies.
5.9 The copies of the controlled quality manual, which are subject to revision, are numbered and these are issued against a receipt. Records of issue of such copies are maintained by Management Representative.
5.10 The Management Representative in consultation with the senior management and head of the departments review the need for changes and suitably incorporate and ensure that such changes are effective.

5.11 Revisions are carried out and are marked by stating the revision status.
5.12 History of changes is maintained as per the details are shown in the quality manual.
5.13 Revised copies are distributed to the processors of controlled copies of the quality manual by means of fresh sheets. Revised copies replace the old sheets.
5.14 The old sheets of the quality manual are returned to the management representative. All other copies are destroyed and recorded.

6.0 ABBREVIATIONS

6.1 MR = Management Representative
6.2 QC = Quality control





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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