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Annexure-3 (1st Page Format of E-content)

The document outlines the concepts and evolution of Quality Control (QC) and Quality Assurance (QA) in pharmaceuticals, emphasizing their importance for patient safety and treatment effectiveness. It covers definitions, historical developments, and regulatory advances that have shaped QC and QA practices, including key legislation like the Pure Food and Drug Act and the Federal Food, Drug, and Cosmetic Act. The content is part of an M.PHARM course at Teerthanker Mahaveer College of Pharmacy, focusing on quality management in pharmaceutical products.

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27 views4 pages

Annexure-3 (1st Page Format of E-content)

The document outlines the concepts and evolution of Quality Control (QC) and Quality Assurance (QA) in pharmaceuticals, emphasizing their importance for patient safety and treatment effectiveness. It covers definitions, historical developments, and regulatory advances that have shaped QC and QA practices, including key legislation like the Pure Food and Drug Act and the Federal Food, Drug, and Cosmetic Act. The content is part of an M.PHARM course at Teerthanker Mahaveer College of Pharmacy, focusing on quality management in pharmaceutical products.

Uploaded by

gulshan rathore
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPT, PDF, TXT or read online on Scribd
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Annexure-03

Title of the e-content

By: Gulshan Rathore

Designation: Assistant Professor

Department: Teerthanker Mahaveer College of

Pharmacy
Teerthanker Mahaveer
College of Pharmacy

M.PHARM- Analysis
Quality Control and Quality Assurance
MPA203T

Unit-1
Concept and Evolution of Quality Control and Quality Assurance:
Good Laboratory Practice, GMP,
Overview of ICH Guidelines - QSEM, with special emphasis on Q-
series guidelines.
Good Laboratory Practices: Scope of GLP, Definitions, Quality
assurance unit, a protocol for the conduct of non-clinical testing,
control on animal house, report preparation and documentation.
Teerthanker Mahaveer
College of Pharmacy

Quality Control and Quality Assurance in Pharmaceuticals

Introduction to Pharmaceutical Quality


Ensuring the quality of pharmaceutical products is essential as it directly
affects patient safety and treatment effectiveness. Two fundamental concepts
in pharmaceutical quality management are Quality Control (QC) and Quality
Assurance (QA). These ensure that medicines meet established standards
before they reach consumers.
Definitions
• Quality Control (QC): A key aspect of Good Manufacturing Practices
(GMP), QC involves the systematic processes of sampling, testing, and
verifying that pharmaceutical products meet required quality specifications
before distribution.
• Quality Assurance (QA): QA encompasses a broad set of practices
aimed at ensuring that quality is built into a product at every stage of its
development, from formulation to final delivery.
Teerthanker Mahaveer
College of Pharmacy

Historical Development of Quality Assurance and Control


Early Quality Concepts
Before the 20th century, drug quality depended largely on empirical methods
used by apothecaries.
Primitive testing techniques were applied to assess the effectiveness of
medicines.
Regulatory Advances in the 1900s
1906: The introduction of the Pure Food and Drug Act in the USA helped
regulate drug quality.
1937: The Sulfanilamide incident, a major drug safety disaster, led to stricter
safety standards.
1938: The Federal Food, Drug, and Cosmetic (FDC) Act made it mandatory for
companies to demonstrate drug safety before marketing.
Mid-20th Century Developments
With industrial advancements, systematic batch testing became standard
practice.
Official compendia such as the USP, BP, and IP introduced standardized drug
testing methods.

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