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Month: November 2013

Basic design of Air Handling Unit (AHU) Design

37 Comments
| Air Handling System, Quality Assurance, Validation

There are different sizes and types of Air Handling Units. Some will fit in a closet or within a ceiling space, while others will require a mechanical room or will need to be placed on the roof of a building. Within all of them, however, there is at least one fan and one method of […]

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Perform Installation Qualification (IQ) in Pharmaceutical Industry

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| Quality Assurance, Validation

Following qualification study to be perform during Installation qualification but not limited to ·         Training sheet (For keep the training attendance ) ·         Purchase order verification (To match with PO) ·         Drawing verification (To verify GA drawing, Electrical drawing etc.) ·         Document verification (To verify Installation manual, operation manual, test certificate etc) ·         Prestart review […]

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Perform Operation Qualification (OQ) in Pharmaceutical Industry

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| Quality Assurance, Validation

Following activity shall be performing during the Installation qualification of but not limited to. General test o   Availability of IQ test report verification o   Standard operating procedure verification o   General function test Automated control o   Verification of Human Machine Interface o   I/O status verification o   Verification of Alarms & Interlocks o   User Access test o   […]

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Guidance to Qualification and Validation towards Global Pharmaceutical Practice

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| Drug regulatory and guidelines, Quality Assurance, Validation

“Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.” QUALIFICATION The premises, the supporting utilities, the equipment and the processes have been designed in accordance with the requirements of GMP. This normally constitutes Design Qualification or DQ. Design qualification […]

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