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QUALITY ASSURANCE
a wide-ranging concept covering all matters that individually or collectively influence the quality of a product.
QUALITY ASSURANCE
can be divided into major areas: development, quality control, production, distribution, and inspections.
QUALITY ASSURANCE
"part of quality management focused on providing confidence that quality requirements will be fulfilled"
QUALITY CONTROL
"A part of quality management focused on fulfilling quality requirements".
QUALITY CONTROL
It is that part of GMP concerned with sampling, specification & testing, documentation & release procedures which ensure that the necessary & relevant tests are performed & the product is released for use only after ascertaining its quality.
QUALITY ASSURANCE
a set of activities for ensuring quality in the processes by which products are developed.
QUALITY CONTROL
a set of activities for ensuring quality in products. The activities focus on identifying defects in the actual products produced.
QUALITY ASSURANCE
a managerial tool.
QUALITY CONTROL
Verification is an example
QUALITY ASSURANCE
aims to prevent defects with a focus on the process used to make the product. It is a proactive quality process.
QUALITY CONTROL
aims to identify (and correct) defects in the finished product. It is a reactive process.
QUALITY ASSURANCE
is to improve development and test processes so that defects do not arise when the product is being developed.
QUALITY CONTROL
to identify defects after a product is developed and before its release.
QUALITY ASSURANCE
Prevention of quality problems through planned and systematic activities including documentation.
QUALITY CONTROL
The activities or techniques used to achieve and maintain the product quality, process and service.
QUALITY ASSURANCE
Establish a good quality management system and the assessment of its adequacy. Periodic conformance audits of the operations of the system.
QUALITY CONTROL
Finding & eliminating sources of quality problems through tools & equipment so that customer's requirements are continually met.
QUALITY ASSURANCE
Everyone on the team involved in developing the product is responsible for quality assurance
QUALITY CONTROL
usually the responsibility of a specific team that tests the product for defects.
QUALITY ASSURANCE
verification is an example
QUALITY CONTROL
Validation is an example
QUALITY ASSURANCE
responsible for ensuring that the quality policies adopted by a company are followed.
QUALITY ASSURANCE
It helps to identify and prepare the necessary SOPs relative to the control of quality.
QUALITY ASSURANCE
It must determine that the product meets all the applicable specifications and that it was manufactured according to the internal standards of GMP.
QUALITY ASSURANCE
holds responsible for quality monitoring or audit function.
QUALITY ASSURANCE
to assess operations continually and to advise and guide them towards full compliance with all applications internal and external regulations.
QUALITY CONTROL
responsible for the day-to-day control of quality within the company.
QUALITY CONTROL
This department is responsible for analytical testing of incoming raw materials and inspection of packaging components, including labelling.
QUALITY CONTROL
They also conduct the required tests on finished dosage form.
QUALITY CONTROL
They conduct in-process testing when required, perform environmental monitoring, and inspect operations for compliance.
QUALITY CONTROL
plays a major role in the selection of qualified vendors from whom raw materials are purchased. Testing of representative samples is required, and in many cases, an audit of vendor's operations is necessary to determine their suitability and degree of compliance with GMPs prior to their being approved.
QUALITY CONTROL
The environmental areas for manufacturing of various dosage forms are tested and inspected by ________.
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