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Factory Acceptance Test (FAT) for Equipment, Utility, System, Facility in the pharmaceutical industry.

Site Acceptance Test [SAT] A test conducted at the manufacturer’s site of use, to verify that the system is meets approved specifications.

The performance of tests to ensure that the system etc. used in a manufacturing process are appropriately selected and correctly installed.

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Alkem Laboratories Ltd Conducting Walk-In Interview for Formulation Manufacturing Facility located at Daman.
Date: 1/10/ 2022
Time: 10:00 AM to 04:00 PM
Venue: Alkem Laboratories Ltd 167, Gandhi Udyog Nagar, Amaliya, Daman-396210

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To check the equipment etc. operates consistently & gives reproducibility within defined specifications & parameters, for prolonged periods

Requalification shall be carried out to ensure the equipment should be maintained in a qualified state throughout the life-cycle of the same

Operational Qualification: Documented verification that the system or subsystem performs as intended overall anticipated operating ranges.

To check the equipment etc. operates consistently & gives reproducibility within defined specifications & parameters, for prolonged periods

Requalification shall be carried out to ensure the equipment should be maintained in a qualified state throughout the life-cycle of the same

US FDA has revised the guideline for Size, Shape, and other physical Attributes of Generic Tablets and capsules. USFDA Guidelines

An emulsion is a dispersed colloidal system consisting of two immiscible liquid phases generally stabilized with one or more suitable agents

PW is used as an excipient in the production of nonparenteral preparations & in other pharma applications, such as cleaning of equipment.

WFI is used as an excipient in the production of parenteral and other preparations where product endotoxin content must be controlled

it is emulsified liquid dosage form intended for external application to the skin, this nomenclature is not currently preferred.

Purified Water that has been vigorously boiled for NLT 5 min, then cooled and protected from absorption of atmospheric carbon dioxide.