General
WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
Utility and Engineering
7 articles
QA
Performance Qualification (PQ): Protocol, Steps & Examples
To check the equipment etc. operates consistently & gives reproducibility within defined specifications & parameters, for prolonged periods
QA
Operational Qualification (OQ): Protocol, Tests & Examples
Operational Qualification: Documented verification that the system or subsystem performs as intended overall anticipated operating ranges.
QA
Installation Qualification [IQ]
The performance of tests to ensure that the system etc. used in a manufacturing process are appropriately selected and correctly installed.
QA
Site Acceptance Test [SAT]
Site Acceptance Test [SAT] A test conducted at the manufacturer’s site of use, to verify that the system is meets approved specifications.
Manufacturing and Packaging
Good manufacturing practices for medical gases
Working document QAS/21.875, February 2021. World Health Organization (WHO) has published the DRAFT WORKING DOCUMENT FOR COMMENTS.
QA
INSPECTION OF UTILITIES
Co-operation Scheme (PIC/S) has revised the guidance document for INSPECTION OF UTILITIES on 19 January 2021