Glossary

Action of proving and documenting that any premises, systems and equipment are properly installed and/or work correctly and lead to the expected results.Qualification is often a part (the initial stage) of validation, but the individual qualification steps alone do not constitute process validation. It is the work done to prove that the supply system will deliver products of the quality required and specified on a routine basis, meeting all the applicable quality requirements.

The suitability of either an active pharmaceutical ingredient or a pharmaceutical product for its intended use. This term includes such attributes as the identity, strength and purity.

“Quality assurance” is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality assurance therefore incorporates good manufacturing practice and other factors, including those outside the scope of this guide such as product design and development.

The person or entity appointed by the employer to assess the quality and suitability of manufacturing sites and/or candidate-approved installers.

Systems and quality control procedures that are established to ensure that the trial is performed and the data are generated in compliance with good clinical practices and good laboratory practices. These include procedures to be followed which apply to ethical and professional conduct, standard operating procedures, reporting, and professional qualifications or skills of personnel.

A physical, chemical, biological or microbiological property or characteristic. A critical quality attribute refers to a characteristic or property that should be within an appropriate limit, range or distribution to ensure the desired product quality.

In the context of this website, quality change refers to a change in the manufacturing process, product composition, quality control testing, equipment or facility. May also be referred to as “chemistry manufacturing and control (CMC) change”.

All measures taken, including the setting of specifications, sampling, testing and analytical clearance, to ensure that raw materials, intermediates, packaging materials and finished pharmaceutical products conform with established specifications for identity, strength, purity and other characteristics.

An appropriate infrastructure, encompassing the organizational structure, procedures, processes and resources, and systematic actions necessary to ensure adequate confidence that a product or service will satisfy given requirements for quality.

A member of staff who has a defined responsibility and authority for ensuring that the management system related to quality is implemented and followed at all times.

A handbook that describes the various elements of the quality management system for assuring the quality of the test results generated by a laboratory.

A systematic process for the assessment, control, communication, and review of risks to the quality of the pharmaceutical product across the product life-cycle.

Explicit written test procedures and requirements that must be met.

An appropriate infrastructure, encompassing the organizational structure, procedures, processes and resources, and systematic actions necessary to ensure adequate confidence that a product (or services) will satisfy given requirements for quality.

The status of starting or packaging materials, intermediates, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection or reprocessing.