QMS

What is Purified water system? A Fundamental Introduction

by

Water is the most common and important Component, being used in the pharmaceutical industry. This is being widely used as a Input Raw material, ingredient and as solvent, purpose is also very vast in regards of its usage. Various sector of pharmaceutical manufacturing industry like Raw material manufacturing, intermediate manufacturing, API manufacturing and formulation intakes … Read more

Elements of Quality management system: An overview

by

Quality management system (QMS) is the linking system between customer requirement and customer satisfactions. Universal goal of quality system is the consistent manufacturing of safe and effective products. Quality management system As per ICH Q10 : management responsibility, Continual improvement of process performance, continual improvement of product quality and continual improvement of pharmaceutical quality system via … Read more

What is Quality Management system for pharmaceutical industry?

by
Quality Management system
Figure:01: Pharmaceutical Quality Management System


Quality management system in pharmaceutical industry is a wide range concept, directly or indirectly influence the quality of the product. Quality management is defined as the aspect of management that determines and implements the “quality policy” i.e. overall intention and direction of an organization regarding quality as formally expressed and authorized by top management.

Quality Management of the pharmaceutical product is the prime
responsibility of the manufacturer. Manufacturing of medicinal products should
be performed with identity, quality, purity and efficacy; having objective to
ensure that products are consistently produced and controlled to the quality
standards appropriate and fit for their intended use. 

What is Quality Management system…… ?

Pharmaceutical Quality
Management system is the main component to achieve this objective. So now a
question arises what is Quality Management system?

Quality Management system
Figure:02: Pharmaceutical Quality Management System


Pharmaceutical
Quality management system should be defined and documents appropriately. Quality
manual or equivalent document should be established by the pharmaceutical
manufacturer that defines the intentions and goal towards the quality of the
products. 

Quality manual also defines the role and responsibility of management.
Senior management has essential role to ensure an effective Pharmaceutical
Quality System is in place. This leadership should make sure the support and
commitment of staff at all levels and sites within the organization to the Pharmaceutical
Quality System.

Read more

Pharmaceutical Quality Management System: An overview

by

Pharmaceutical Quality Management System

Pharmaceutical Quality Management is a comprehensive concept, which covers all
matters, which independently or jointly influence the pharmaceutical product
quality. 

In totality this concept defines an organized arrangement made with the purpose of ensuring
that medicinal products are of the quality required for their anticipated or
intended use. Therefore Good Manufacturing Practice incorporated in Quality
Management System (QMS).

Pharmaceutical Quality Management System
Pharmaceutical Quality Management System: An overview


Management has the responsibility to make sure QMS are
set up in such a way that ensures state of control, for;

  • Good manufacturing practices,
  • Stockholder
    value, 
  • Achieving Goals, 
  • Continual improvement. 

There are number of companies which are under consent
decrees or that have obtained FDA warning letters indicates that management
supervision of cGMP compliance is a continuing and significant problem on the
marketplace. 

Companies have been unprecedented impact, loss of brand loyalty, stockholder
suits, and reputations. Sooner or later, the warning signs unheeded were
unnoticed, or rationalized away.

This article describes the issues that might affect the ability of
management to discover the signs of cGMP compliance issues that are important
and provides suggestions on the way to gain control over this portion of the
business. Overlooking of Pharmaceutical Quality Management System may
impact the trustworthiness of a brand. 

Read more