importance of validation in pharmaceutical machines manufacturing process –
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PHARMAMACH (INDIA) PVT. LTD.
Importance of Validation to the Manufacturing Process
The basis of validation is to provide documentary evidence of conformance to thelaid down standards such as the federal drugs agency regulations. The fundamentalelements that the validation process seeks to qualify include;
Proper installation. All parts properly bolted in best operating environment.
Performance and operation; the machine performs as per the expectations.
Process validation; Seeks to explain that the manufacturing and verificationprocess can be done continuously as long as the process is ongoing.
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Importance Quality Checks For Pharmaceutical Machines
Maintenance of quality in a machine is crucial in every process. In the drugs makingprocesses, Fluid bottling machines have nozzles that must be continuously calibratedto ensure precise delivery into bottles. Powder and dry syrup packing machines havevery sensitive calibration procedures due to the sensitive nature of human medicine.
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Hardware and Software Validation for Process Efficiency
Machinery software validation is critical because it is the driver of the machine.Validation is important to ensure that software structure is published andimplemented with items such as development environment, security, maintenancefeatures and revision process. A sample operating code should also be availed by thevendor as well as a support plan.
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Determining Maintenance Triggers While Developing Machinery
These are observations in theoperation of the machine that willprompt the user to do maintenance tothe machine. They include qualitydeterioration, leakages, expiry ofstipulated time by manufacturers andeven changes in personnel. When aWet glue labeling machine deliversdeformed or misaligned labels, it istime to service.
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Developing Functional Requirements as a Preliquisite in Construction
The functional requirements must bedeveloped before manufacturing of theequipment. This document must notstate the specific devices to be used butrather the process required to produce aquality and useful product.
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Importance of Auditing Pharmaceutical Machine Manufacturers
Auditing is important in every industry.System audits give documentary evidenceof compliance to the regulations andstandards. Verification and validationensure that what is being done is theactually the best practice in the industry.
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Gujarat INDIA
Phone:- +91 79 40213213Email: [email protected]
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