Guidelines for preparation of quality manual

 · A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical quality system. The description should include: (c) Identification of the pharmaceutical quality system processes, as well as their sequences, linkages and www.doorway.rus: 1. Guidelines for Developing Quality Documentation A. INTRODUCTION This document provides guidance for the development, preparation and control of quality manuals tailored to the specific needs of the user. The resultant quality manuals should reflect documented quality system procedures required by the ISTA Accreditation Standard. This section of the Management System Document / Quality Manual should clearly mention the compliance to the applicable standard(s) and NABL documents. It should also define the field(s)/ discipline(s)/ area(s) and the section(s)/ division(s) department(s) of the CAB, to which the Management System Document / Quality Manual is applicable.

Quality Manual should contain approved quality policy and measurable quality objectives. 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. Guidelines for Developing Quality Documentation A. INTRODUCTION This document provides guidance for the development, preparation and control of quality manuals tailored to the specific needs of the user. The resultant quality manuals should reflect documented quality system procedures required by the ISTA Accreditation Standard. demonstrating to clinicians and the hospital administration a commitment to quality(1). “ The laboratory shall define and document its policies and objectives for, and its commitment to, good laboratory practice. The hospital management shall ensure that these policies and objectives are documented in the quality manual and communicated to, understood by, and implemented by all laboratory personnel concerned. The quality manual contents are as follows2”: Contents of quality manual.

The purpose of these Guidelines is to assist govenment drug control laboratories in the preparation of a quality manual that describes the elements and. ISO standards of family assist in designing and implementing quality management system in an organization. QMS increases the efficiency and effectiveness. This quality manual is a controlled document forming the framework of the quality management The list below covers requirements for all licence classes.