The Difference between Specifications and Quality Attributes - FDA Definitions (2024)

FAQs

What is the difference between quality and specifications? ›

Quality is the process of meeting requirements. Specifying is a quality process, and it is important to make certain that specifications are clear about suitable quality standards, procedures, and tests. Quality is determined by product users, clients, or customers, not by society in general.

The quality attributes of a drug product may include identity, assay, content uniformity, degradation products, residual solvents, drug release or dissolution, moisture content, microbial limits, and physical attributes such as color, shape, size, odor, score configuration, and friability.

A CQA is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. CQAs are difficult to measure directly in production.

Quality attribute criticality is primarily based upon severity of harm and does not change as a result of risk management. Process parameter criticality is linked to the parameter's effect on any critical quality attribute.

Both have to meet certain criteria related to them. A product's conformity to specifications is relatively measurable: It either conforms or not. A product's quality is more than just specs and may not be easily measurable. Product quality is meeting or exceeding the intended user's expectations.

Product-based definition: quality refers to the attributes/characteristics or features that a product has. User-based definition: a product has quality if it satisfies the user requirements.

Quality attributes, also known as quality factors, quality characteristics, or non-functional requirements , are a set of system functional and non-functional requirements that are used to evaluate the system performance.

A quality attribute is a characteristic of a system that is used to evaluate the system's performance from the perspective of the end user. Determining the right set of characteristics to assess a system's performance is the first step in quality control and management.

Quality attribute requirements such as those for performance, security, modifiability, reliability, and usability have a significant influence on the software architecture of a system. Architects need to understand their designs in terms of quality attributes.

(y) Specification means any requirement with which a product, process, service, or other activity must conform. (z) Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

What is the FDA definition of quality plan? ›

Quality Plans

The firm must have a written quality plan that defines the quality practices, resources and activities relevant to the devices that are being designed and manufactured at that facility. The manufacturer needs to have written procedures that describe how they intend to meet their quality requirements.

Critical Attribute: A characteristic of

something that is imperative to its definition. Example: The critical attributes of a table would. be a flat surface and legs supporting the flat. surface.

A Critical Process Parameter (CPP) is a term used in pharmaceutical production for process variables which have an impact on a critical quality attribute (CQA) and, therefore, should be monitored or controlled to ensure the drug product obtains the desired quality.

CPPs are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in critical quality attributes. Those attributes with a higher impact on CQAs should be prioritized and held in a stricter state of control.

Standards refer to guidelines and specifications that set the minimum requirements for a system, service, or product to ensure its efficiency and safety. On the other hand, quality refers to the overall superiority, fitness for purpose, and the degree of satisfaction that a product or service provides to its users.

Quality specifications are detailed requirements that define the quality of a product, service or process. Quality includes tangible elements such as measurements and intangible elements such as smell and taste. The following are illustrative examples of quality specifications.

Quality of design. is defined as a fit between a product's (service's) design and customer needs; quality of. conformance is defined as a fit between the attributes of an actual product and its. specification. In order to satisfy customers, quality should be high on both dimensions.