AUTOCLAVE – MAINTENANCE AND VALIDATION
AUTOCLAVE – MAINTENANCE AND VALIDATION Qualification and Validation With such importance placed on the autoclave how can the user be
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Changes as per SUPAC Guideline Part -I (components or composition)
Changes as per SUPAC Guideline Part -I (components or composition) During the post-approval period, to change: 1) The components or
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Operational Qualification of Fluid Bed Processor In Pharma
Operational Qualification of Fluid Bed Processor In Pharma Operational qualification is the process of demonstrating that Fluid Bed Processor will
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Film Coating By by design of experiments
Film Coating By by design of experiments To identify and screen the critical process parameters by design of experiments and
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SOP for Responsibility of Compounding Personnel in sterile preparation
SOP for Responsibility of Compounding Personnel in sterile preparation Compounding personnel is responsible for ensuring that Compounding sterile preparations (CSPs) are
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Documentation for Manufacture of Pharma Sterile Products
Documentation for Manufacture of Pharma Sterile Products The Documents relating to the manufacture of sterile products shall be as follows
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SOP for Out of Specification (OOS)
SOP for Out of Specification (OOS) SOP for the procedure for handling, investigating, and reporting test results, which do not
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Disposal of waste
Disposal of waste Disposal of waste means eliminating, scraping, recycling, or destroying unwanted materials known as waste that is generated
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Handling of external laboratory activities
Handling of external laboratory activities To lay down a procedure for qualifying, auditing, sending samples with reference to testing procedures,
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Procedure of laundry
Procedure of laundry To lay down the procedure for describing the steps to be followed for laundry the uniform. This
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EXCEL SHEET VALIDATION
EXCEL SHEET VALIDATION The objective of this procedure is to establish the guideline for the validation of Microsoft Excel spreadsheets
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CALIBRATION OF DIES REQUIRED FOR BLEND SAMPLING
CALIBRATION OF DIES REQUIRED FOR BLEND SAMPLING The objective of this procedure is to establish the guideline for the calibration
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HANDLING COUNTERFEIT/FALSIFIED MATERIALS
HANDLING COUNTERFEIT/FALSIFIED MATERIALS To lay down a standard procedure that describes handling counterfeit/falsified materials. Applicable for the procedure of handling
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Technology Transfer
Technology Transfer To lay down a procedure for technology transfer of new products to be taken. The scope of this
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Shipping Validation
Shipping Validation Objective The objective of this study is to establish a procedure to record temperature data to ensure that
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COATING PANS
COATING PANS CONTENTS: COATING PROCESSES TYPES OF COATING PANS CONVENTIONAL COATING PANS PERFORATED COATING PANS VALIDATION OF COATING PANS IQ
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AUTOCLAVE – MAINTENANCE AND VALIDATION
AUTOCLAVE – MAINTENANCE AND VALIDATION. INTRODUCTION An autoclave is a device to sterilize equipment and supplies by subjecting them to
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