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ZENODO
Article . 2024
License: CC BY
Data sources: ZENODO
ZENODO
Article . 2024
License: CC BY
Data sources: Datacite
ZENODO
Article . 2024
License: CC BY
Data sources: Datacite
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Requalification of Friability Testing Apparatus

Authors: Chethan, TP; Kavya, S; Abhishek, Singh; Rishu, Yadav; Laxmi, Yadav; Samruddhi, Phansekar; Shailendra, Gupta; +1 Authors

Requalification of Friability Testing Apparatus

Abstract

Re-qualification as a part of validation is the task performed to identify or check that utilities, equipment and ancillary systems can operate within limits for their intended use. Equipment qualification is a key element in the pharmaceutical quality system. In recent times regulatory agencies are more focusing on qualification of equipment. Re-qualification of the equipment starts from design of the equipment based on the user requirement specification and functional requirement specification. The review article provides information on design qualification which is done to identify whether the proposed design of facilities, system and equipment is suitable for intended purpose, installation qualification which is done to check whether the equipment is built and installed in compliance with design specification, operational qualification in which the process parameters shall be challenged to assure that product meets all requirements and finally performance qualification to demonstrate that the process will produce acceptable product consistently under normal operating conditions.

Keywords

Re-qualification; Operational qualification; Design qualification; Installation qualification; Performance qualification

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    influence
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
Green