Basic concepts of Quality Assurance and Quality Control

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, quality control, production, distribution, and inspections.

ISO 9000

defines Quality Assurance as "part of quality management focused on providing confidence that quality requirements will be fulfilled".

Quality Control

ISO 9000 defines it as "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

is a set of activities for ensuring quality in the processes by which products are developed

Quality Assurance

is a managerial tool.

Quality Assurance

aims to prevent defects with a focus on the process used to make the product. It is a proactive quality process.

Quality Assurance

The goal of it is to improve development and test processes so that defects do not arise when the product is being developed.

Quality Assurance

Prevention of quality problems through planned and systematic activities including documentation.

Quality Assurance

Establish a good quality management system and the assessment of its adequacy. Periodic conformance audits of the operations of the system.

Quality Assurance

Everyone on the team involved in developing the product is responsible for it

Quality Assurance

verification

Quality Control

is a set of activities for ensuring quality in products. The activities focus on identifying defects in the actual products produced.

Quality Control

aims to identify (and correct) defects in the finished product.

Quality Control

a reactive process.

Quality Control

The goal of it is to identify defects after a product is developed and before its release.

Quality Control

The activities or techniques used to achieve and maintain the product quality, process and service.

Quality Control

Finding & eliminating sources of quality problems through tools & equipments so that customer's requirements are continually met.

Quality Control

is usually the responsibility of a specific team that tests the product for defects.

Quality Control

Validation

QA department

is 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

also holds responsible for quality monitoring or audit function.

Quality Assurance

functions to assess operations continually and to advise and guide them towards full compliance with all applications internal and external regulations.

Quality Control

is 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 conduct in-process testing when required, perform environmental monitoring, and inspect operations for compliance.

Quality Control

They also conduct the required tests on finished dosage form.

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 this department.

1. Raw Material

2. In process variations

3. Packaging material

4. Labelling

5. Finish product

6. Manual Error

Following variables may affect ultimate quality of product.

Raw material control

Good raw material specifications must be written in precise terminology, must be complete, must provide specific details of test methods, type of instruments, and manner of sampling must be properly identified.

Raw material control

Each raw material is sampled according to standard sampling procedures and is sent to the quality control laboratory for testing according to written procedures. If acceptable, it is moved to the release storage area, after being properly stickered to indicate the item no., material name, lot no., release date, reassay date and sign of QA inspector.

7 years

amount of time preservation samples should be retained

QA personnel

should keep preservation samples of active raw materials that consists of atleast twice the necessary quantity to perform all tests required, to determine whether the material meets the established specifications.

Active or therapeutic

Inactive or inert

Raw materials may be classified into 2 groups

In-process Items Control

Conformance to compendial standards as the sole basis for judging the quality of a final dosage form can be grossly misleading as the final dosage forms are produced in millions of units, the no. Of units assayed at the end is not likely to be representative of more than a small fraction of the actual production.

FDA-CGMP regulations

emphasize environmental factors to minimize cross contamination of products and errors, however, they do little to minimize within-batch and batch-to-batch variation

IPQA program

ensure that the final products have uniform purity and quality

QA before start-up

Environmental and microbiologic control and sanitation

QA before start-up

Manufacturing Working Formula Procedures

QA before start-up

Raw Materials Manufacturing Equipment

QA at start-up

Raw Material Processing

QA at start-up

Compounding

QA at start-up

Packaging Materials Control

QA at start-up

Labels Control Finished

Manufacturing Variation Control

Monitoring environmental conditions under which products are manufactured/stored

Manufacturing Variation Control

Monitoring of air and water systems to prevent contamination- Air Handling Units

Manufacturing Variation Control

Monitoring of personnel

Manufacturing Variation Control

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