Glossary

(ICH Q8 (R2)/Q6A) The suitability of either a drug substance or a drug product for its intended use. This term includes such attributes as the identity, strength, and purity.

(ICH Q10) The degree to which a set of inherent properties of a product, system or process fulfils requirements.

(ICH Q9) The degree to which a set of inherent properties of a product, system or process fulfills requirements. [see ICH Q6A definition specifically for "quality" of drug substance and drug (medicinal) products].

Although in one sense everyone is responsible for the compliance and quality issues and adherence to these, Quality is overall responsible for assuring Management that procedures are adhered to. This role may be split into regulatory, Quality, and Validation.

The suitability of either a drug substance or drug product for its intended use. This term includes such attributes as the identity, strength, and purity (from ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances).

The activity of or group responsible for ensuring that the facility and systems meet GxP requirements.

(ISO) The planned systematic activities necessary to ensure that a component, module, or system conforms to established technical requirements.

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

All actions that are taken to ensure that a development organization delivers products that meet performance requirements and adhere to standards and procedures.

The policy, procedures, and systematic actions established in an enterprise for the purpose of providing and maintaining some degree of confidence in data integrity and accuracy throughout the lifecycle of the data, which includes input, update, manipulation, and output.

The actions, planned and performed, to provide confidence that all systems and components that influence the quality of the product are working as expected individually and collectively.

(ICH Q7) The sum total of the organized arrangements made with the object of ensuring that all APIs are of the quality required for their intended use and that quality systems are maintained.

The activity of or group responsible for ensuring that the facility and systems meet GMP requirements.

The activity of, or group responsible for, ensuring that all materials, personnel, facilities, and systems are of the quality required for their intended use or role, and that effective quality systems are maintained.

The group who interprets the GMP regulations and guidelines.

Process by which proposed changes to a qualified system are assessed before implementation to determine the impact on the system. Proposed changes must be approved prior to implementation.

An independent part of the organization responsible for assuring, or controlling, the quality and compliance with predicate rules of all applicable products and services of the organization.

A molecular or product characteristic that is selected for its ability to help indicate the quality of the product. Collectively, the quality attributes define identity, purity, potency and stability of the product, and safety with respect to adventitious agents. Specifications measure a selected subset of the quality attributes.

A physical, chemical, or microbiological property or characteristic that directly or indirectly relates to pre-defined product quality (safety, identity, strength, purity, and marketability of the product).