ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Quality

(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].

Publication Source: GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems

Publication Date: 2008

Quality

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.

Publication Source: GAMP® Good Practice Guide: Electronic Data Archiving

Publication Date: 2007

Quality

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

Publication Source:

Quality

(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.

Publication Source:

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