Quality assurance and quality control | different between QA and QC | DIFFERENT BETWEEN QUALITY ASSURANCE AND QUALITY CONTROL

Definition of quality:

ISO defines as:

The totality of features and characteristics of product of service that bear on its ability to satisfy given needs.

Quality means that the products meet and exceed all requirements, standards and specification. Examples, certain industry products may need to meet specific standards and specification for legal reasons.

Importance of quality:

A high-class product or service is developed with the help of quality.
Customer satisfaction, which finally results in loyalty from customers, depends on quality.
A company may create a product or service that customers demand with the help of quality management.

Quality assurance definition:

According to WHO, quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product.
With regard to pharmaceuticals, quality assurance can be divided into major areas: development, production, quality control, distribution, and inspections.

ISO 9000 defines as:

Part of quality management focused on providing confidence that quality requirements will be fulfilled.

Objectives of Quality Assurance

The objectives of QA system in a pharmaceutical industry are to ensure that. Product design and development is in accordance with requirements of cGMP, Good Laboratory Practices (for non-clinical developmental studies) and Good Clinical Practices (for clinical studies), all operations in production and control steps are specified clearly in writing. Managerial responsibility is specified clearly in each job description.
Correct starting materials and packaging materials are used to manufacture drug products.
Appropriate controls such as in-process checks, calibrations and validations - exist to ensure quality of raw materials, intermediate products and finished products.
Finished products are appropriately checked in accordance with pre-determined Procedures.
Every production batch is certified by authorized persons before it is released for sale.
There are satisfactory measures adopted to ensure quality of the product which is and supply maintained throughout its shelf life.
Procedures exist for regular self-inspection or quality audits to assess the effectiveness of the QA system.
Deviations of any nature are reported, adequately investigated and the results are recorded.
Changes having an impact on product quality are adopted through a system that calls for approval from management.
Quality of products is regularly evaluated in order to verify that the process consistently providing quality products.

Responsibilities of quality assurance:

Quality control

Its that part of GMP concerned with sampling, specification and testing, documentation and relevant tests are performed and the product is released for use only after ascertaining its quality.

ISO 9000 defines as

Objectives of Quality Control

The objectives of QC department in a pharmaceutical industry are to ensure that: There is a day-to-day control maintained over the quality aspects of drug products.
Incoming raw materials, in-process goods and finished products are all tested for compliance with predetermined quality specifications.
Environmental monitoring is performed to make sure products are manufactured, packed and stored under prescribed conditions.
Instruments are calibrated and working as expected.
Analytical methods are developed and validated to assure they stay capable of providing results that are accurate and predictable.

Responsibilities of quality control:

QC is responsible for the day-to-day control of quality within the company.
QC department is responsible for analytical testing of incoming raw materials and inspection of packaging components, including labeling.
To conduct in-process testing when required, perform environmental monitoring and inspect operations for compliance.
They also conduct the required tests on finished dosage form.
QC plays a major role in the selection of qualified vendors from whom raw materials are purchased.
The environmental areas for manufacturing of various dosage forms are tested and inspected by quality control department.
Maintenance of all documents related to quality control department.

Different between quality assurance and quality control:

	Quality assurance	Quality control
Definition	QA is a set of ensuring quality in the processes by which products are developed.	QC is a set of activities for ensuring quality in products. The activities focus on identifying defects in the actual products produced.
	QA is a managerial tool.	QC is a corrective tool
Focus or aim	QA aims to prevent defects with a focus on the process used to make the product.	QC aims to identify defects in the finished product.
	It’s a proactive quality process.	It’s a reactive process.
Goal	QA is to improve development and test processes so that defects do not arise when the product is being developed.	QC is to identify defects after a product is developed and before its released.
Work	Prevention of quality problems through planned and systematic activities including documentation.	The activities or techniques used to achieve and maintain the product quality, process and service.
	Establish a good quality management system and the assessment of its adequacy.	Finding and eliminating sources of quality problems through tools and equipment so that customers requirements are continually met.
Responsibilities	Everyone on the team involved in developing the product is responsible for quality assurance.	QC is usually the responsibility of a specific team that tests the product for defects.
	Eg. Verification	Eg. validation

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