Get Justification Of Specification Example

A specification is a quality standard. It establishes the criteria to which a substance should conform to be considered acceptable for the manufacture of medicinal products. Thus, specification includes a list of tests, references to analytical procedures and appropriate acceptance criteria for the tests described.

Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval. Specifications are one part of a total control strategy for the drug substance and drug product designed to ensure product quality and consistency.

Specifications (test and acceptance criteria) for active pharmaceutical ingredients (APIs) and drug products are defined in ICH Q6A. It 'establishes a set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use.

Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval. Specifications are one part of a total control strategy for the drug substance and drug product designed to ensure product quality and consistency.

Release Specifications means the set of analytical tests, methods, and acceptance criteria for Product attributes which must be met in order to prove the Product meets the standards of quality, purity, identity and strength filed with the FDA for this substance.

Intermediate is a kind of material produced in the process of API, which can only be turned into API by further molecular change or refinement. Intermediates can be separated or not separated. API is Active Pharmaceutical Ingredients. ... It is also an active ingredient in pharmaceuticals when used in pharmaceuticals.

Specifications (test and acceptance criteria) for active pharmaceutical ingredients (APIs) and drug products are defined in ICH Q6A. It 'establishes a set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use.

One way of setting out a 'justified' specification is shown below. In the first column a specification point is written as a sentence(s). In the second column, the point is justified by referring back to specific research findings. Further justification for each specification point, can be added in a third column.

The definition of a specification is a precise requirement, or a detailed description of workmanship, materials or processes. A mandate that only domestic plywood be used in the construction of your home is an example of a specification. The act of specifying.

Release Specifications means the set of analytical tests, methods, and acceptance criteria for Product attributes which must be met in order to prove the Product meets the standards of quality, purity, identity and strength filed with the FDA for this substance.

Release Specifications means the set of analytical tests, methods, and acceptance criteria for Product attributes which must be met in order to prove the Product meets the standards of quality, purity, identity and strength filed with the FDA for this substance.

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. Potential drug substance CQAs are used to guide process development.