Glossary

(ICH Q10) Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectives. (ISO 9000:2005)

(ICH Q10) Overall intentions and direction of an organization related to quality as formally expressed by senior management. (ISO 9000:2005)

Include:• System Impact Assessment• Active participation of the Quality assurance department• Enhanced documentation, document management and a structured approval process• QA Change control• Greater end user participation• Training• Use of Qualifications Rationales to identify what should be checked, how, to what extent, why and by whom• Deciding what not to check and why

Documented evidence of activities performed or results achieved to fulfill requirements for quality.

(ICH Q9/Q10) A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle.

Planned and systematic activities necessary to provide adequate confidence that a product, process, or service satisfies specified quality requirements.

(ICH Q9) The sum of all aspects of a system that implements quality policy and ensures that quality objectives are met.

The organizational structure, procedures, processes, and resources needed to implement quality management.

(ICH Q8 (R2)) A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product.

The person or organizational element at the site, having oversight responsibility for assuring that the drug or drug products produced, consistently meet their pre-defined attributes through a proven process. Responsibilities of the Quality Unit are typically divide between Quality Control (QC) and Quality Assurance (QA) functions.

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

The term Quality Unit is used here as an encompassing term that includes many quality-related roles that are important to developing and managing regulated computerized systems. The manner in which a Quality Unit addresses the responsibilities noted below may vary based on the applicable regulations.

The Quality Unit has a key role within the quality management system governing facilities, systems, and equipment. In addition to acting as a Subject Matter Expert (SME), the Quality Unit is responsible for overseeing quality and compliance.

(ICH Q7) An organizational unit independent of production that fulfills both Quality Assurance and Quality Control responsibilities. This may be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization.

The quantitation limit of an individual analytical procedure is the lowest amount of analyte in a sample that can be quantitatively determined with suitable precision and accuracy.

(ICH Q2 (R1))The quantitation limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy. The quantitation limit is a parameter of quantitative assays for low levels of compounds in sample matrices, and is used particularly for the determination of impurities and/or degradation products.

The area of genetics concerned with the inheritance of continuously-varying traits. Most practical improvement programs involve the application of quantitative genetics.

Inheritance of measurable traits (height, weight, color intensity, etc.) that depend on the cumulative action of many genes.

A measurable trait that shows continuous variation; a trait that cannot be classified into a few discrete classes.

(ICH Q7) The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection.

(FDA) A review being developed by the Office of Generic Drugs (OGD) for its Chemistry, Manufacturing, and Controls (CMC) evaluation of Abbreviated New Drug Applications (ANDAs), that is focused on critical pharmaceutical quality attributes. The QbR is a concrete and practical implementation of the underlying concepts and principles outlined by the FDA’s cGMPs for the 21st Century and PAT initiatives. It will transform the CMC review into a modern, science and risk-based pharmaceutical quality assessment.

DNA mutants of E. coli cease replication immediately when the temperature is increased to 42°C.