OPERATIONAL 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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Responsibilities 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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General Verification
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Functional Verification
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Deviation
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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Operational Qualification Approval
Revision History
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Annexure 1
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Annexure 2
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