INTRODUCTION

⚫ Concept of quality according to U.S.F.D.A.

"Quality should be built into the product, and testing alone cannot be

relied onto ensure product quality".

⚫ building of quality into the product ??????

⚫ stage wise controls incorporates controls on all input resources.

QMS

• Quality : degree of fines

• Management : coordinated activities

• System: set of interactions/integrated elements

Single system

To achieve Quality, mission, vision, goals, objectives

QMS

• Structured collection of policies, procedures, processes.

Objectives of Quality Management

• Provide high-quality drug product.

• Prevent or reduce the number of recalls

• Harmonise the cGMPs.

• To help in getting quality by design.

• To achieve success in business.

8
Definition of Quality Management

• The W.H.O. guidelines of G.M.P. define quality management as

follows:

• Quality Management may be defined as:

“The aspects of management function that determines and

implements the “quality policy.”