What is Quality Policy?

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Quality Policy; When we talk about the Quality management
system (QMS) in pharmaceutical industry, Quality
Policy is an important term within it. This term can be easily understood
by some of the below questions.

Quality Policy, QMS, Quality Management System

What is the definition of Quality Policy?

Term
“Quality Policy” is self defining term, means a policy or statement on Quality. In Quality management system (QMS) this term is used for a documented procedure, to give you an idea about commitment and strategic direction of the organizational management
towards Quality of the product.  This
should be the aim of the organization.


WHO
says “A brief statement (Quality Policy Statement) that describes
the organization’s purpose, overall intentions and strategic direction,
provides a framework for quality objectives and includes a commitment to meet
applicable requirements”.

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ICH says inline to ISO (9000:2005), “Quality
policy is an overall intention and direction of an organization related to quality
as formally expressed by the senior management”.

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USFDA
defines Quality policy as “A statement (Quality Policy Statement) of
intention and direction issued by the highest level of the organization related
to satisfying customer needs. It is similar to a strategic direction that
communicates quality expectations
that the organization is striving to achieve”. 

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Who prepares Quality policy and why it is
important?

This
is responsibility of top management / higher management of an organization, to establish
a clear Quality policy statement.
Organizational quality objectives can be said “operational planning” should be
based on the Quality policy.

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Pharmaceutical regulatory authorities All over the world

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What are the Pharmaceutical regulatory authorities  Pharmaceutical regulatory authorities are established by the various countries with the objective, to ensure the quality, safety and efficacy of the pharmaceutical product, these products includes medicines and medical devices both. These Pharmaceutical regulatory bodies are working on certain set of the rules and regulation those are needs to … Read more

Elements of Quality management system: An overview

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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?

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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.

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Biosorption: Effective method for removal of heavy metal from Aqueous medium

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Environmental contamination by toxic heavy metals like copper, lead, zinc, cobalt, mercury and chromium, due to various anthropogenic activities has become one of the serious problems of worldwide concern Presence of these metals in aqueous streams has been responsible for several health problems associated with animals, plants and human beings. “Biosorption” an effective method for … Read more

Pharmaceutical Quality Management System: An overview

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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. 

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Coronavirus (COVID-19): Facts for Precautions & Care

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Facts – Precautions and information  ‘New coronavirus: COVID-19’ Fig.: 01 – COVID-19 ·         New coronavirus spreads in cold regions only? Fact # 1 The New coronavirus can be transmitted in areas with hot and humid climates. ·        Eating garlic help prevent infection with the new coronavirus? Fact # 2 Garlic is a healthy food that may have some antimicrobial … Read more