Definition Preparation Approval and Revision of Master Documents

1.0 PURPOSE

To lay down the procedure for Defining, Preparation, Approval and Revision of Master Documents.

2.0 SCOPE

2.1This procedure is applicable in all departments.

3.0 RESPONSIBILITY

3.1 Heads of all department

4.0 ACCOUNTABILITY

4.1 Manager- QA & RA

5.0 PROCEDURE

5.1 A Master document is defined as one or more of the following:

5.1.1    Documents required to describe the quality system requirements in the organization.

5.1.2    Documents required to describe the product or process characteristics.

5.1.3    Documents required by various regulatory agencies as part of compliance to GxP requirements.

5.1.4    Documents required for legal / regulatory support of the organization to meet the local regulations.
5.1.5    Any other document required by government / regulatory agency.

5.2    Manager – QA & RA shall define the master documents and maintain a list of master documents in QAxxxxx

5.3    Manager – QA & RA shall ensure procedures to prepare, approve, train, distribute and comply the proved master documents.

5.4    Manager – QA & RA shall ensure proper change control procedures for review and revision of aster documents.

5.5    Manager – QA & RA shall ensure preservation, archival and retrieval of obsolete versions of master documents whenever required.

END OF DOCUMENT

Master documents, definition, preparation approval,quality assurance