Manufacturing and PackagingWHO TRS 1044 (2022): 56th Report Annexes & PDF
WHO Expert Committee on Specifications for Pharmaceutical Preparations has published the Technical Report Series TRS 1044 2022 56th Report
Utility and Engineering
12 articles
Manufacturing and Packaging
GeneralPure Steam
Pure Steam— is also sometimes referred to as “clean steam”. It is used where the steam or its condensate would directly contact official articles or
GeneralWater for Hemodialysis
Water for Hemodialysis is used for hemodialysis applications, primarily the dilution of hemodialysis concentrate solutions.
GeneralWater for Injection
WFI is used as an excipient in the production of parenteral and other preparations where product endotoxin content must be controlled
GeneralWATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
QAPeriodic Review and Requalification
Periodic review and requalification: Periodic review and requalification shall be carried out to ensure the Utilities and equipment should be maintained
QAPerformance Qualification (PQ): Protocol, Steps & Examples
To check the equipment etc. operates consistently & gives reproducibility within defined specifications & parameters, for prolonged periods
QAOperational Qualification (OQ): Protocol, Tests & Examples
Operational Qualification: Documented verification that the system or subsystem performs as intended overall anticipated operating ranges.
QAInstallation Qualification [IQ]
The performance of tests to ensure that the system etc. used in a manufacturing process are appropriately selected and correctly installed.
QASite 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 PackagingGood manufacturing practices for medical gases
Working document QAS/21.875, February 2021. World Health Organization (WHO) has published the DRAFT WORKING DOCUMENT FOR COMMENTS.
QAINSPECTION OF UTILITIES
Co-operation Scheme (PIC/S) has revised the guidance document for INSPECTION OF UTILITIES on 19 January 2021