PERFORMANCE QUALIFICATION PROTOCOL CUM REPORT OF TABLET COATER FOR ACG PHARMA TECHNOLOGY
NAME OF EQUIPMENT: ACG PHARMA TECHNOLOGIES PVT. LTD
MODEL/SERIAL NO.: SMART COATER (SC700)
Tablet Coaters:
Tablet coaters are essential in pharmaceutical manufacturing, applying a thin layer of material to tablet surfaces. This process offers numerous benefits, including masking unpleasant tastes, protecting drugs from environmental factors, controlling drug release, and enhancing the tablet’s appearance. Tablet coating machines use a variety of techniques, such as spray coating or dip coating, to apply the coating material uniformly. The choice of coating material and method depends on the specific requirements of the drug and desired outcome. Coated tablets improve patient compliance, enhance product stability, and enable the development of innovative drug delivery systems.
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Table of Content
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Protocol cum report Approval
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OBJECTIVE
SCOPE
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RESPONSIBILITY AND IDENTIFICATION OF EXECUTION TEAM
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EQUIPMENT DESCRIPTION
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EQUIPMENT DESCRIPTION
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EQUIPMENT DESCRIPTION
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EQUIPMENT DESCRIPTION
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QUALIFICATION APPROACH AND ACCEPTANCE
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QUALIFICATION APPROACH AND ACCEPTANCE
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QUALIFICATION APPROACH AND ACCEPTANCE
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QUALIFICATION APPROACH AND ACCEPTANCE
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QUALIFICATION APPROACH AND ACCEPTANCE
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QUALIFICATION APPROACH AND ACCEPTANCE
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QUALIFICATION APPROACH AND ACCEPTANCE
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QUALIFICATION APPROACH AND ACCEPTANCE
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Deviation(S) If Any
Actions, if any
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LIST OF GENERAL AND FUNCTION VERIFICATION FORMATS USED
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Summary and Conclusion
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PERFORMANCE Qualification Approval
Revision History
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