Quality Control

SOP For Operation, Maintenance And Calibration Of Ultrasonic Water Bath

The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for Operation, maintenance and Calibration of Ultrasonic Water Bath. PROCEDURE: PRELIMINARY CHECK: Fill the Water bath with water up to height of minimum 7cm from bottom of tank. Whenever the Ultrasonic Water Bath is required with specific temperature then heater to …

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SOP for Handling of Laboratory Reagents

Standard Operating Procedure (SOP) for Receipt, Storage, and Handling of Laboratory Reagents, Buffers, Solvents, Glasswares and other consumables in QC. Receipt, Storage, and Handling of Laboratory ReagentsPurpose : The purpose of this SOP ( Standard Operating Procedure) is to describe the procedure for the receipt, storage, and handling of laboratory reagents. Scope : This procedure …

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Acceptable Quality Level (AQL) – SOP and Chart

OBJECTIVE: To define the procedure for Acceptable Quality Level sampling for Tablets and Capsules during bulk approval. SCOPE: This procedure is applicable to bulk approval of manufactured Tablets and Capsules at pharmaceutical product manufacturing location.     REFERENCES: ISO 2859-1:1999(en) Sampling procedures for inspection by attributes SOP for Event Reporting and Investigation. DEFINITIONS OF TERMS: …

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SOP on Operation and Calibration of Melting Point Apparatus

Standard Operating Procedure (SOP) for Operation and Calibration of Melting Point Apparatus used for analysis / identification  of starting materials (Raw Material – API & Excipient) in Quality Control Laboratory. Operation and Calibration of Melting Point Apparatus 1.0   PURPOSE: The purpose of this SOP is to describe the procedure for operation, calibration and maintenance of …

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SOP For FTIR

Standard Operating Procedure (SOP) for Operation, Calibration, Cleaning, and Maintenance of FTIR (Fourier Transform Infrared Spectrometer). Procedure for Operation and Calibration of FTIR 1.0   PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the start-up, operation, calibration, and maintenance procedure of the FTIR – Fourier Transform Infrared Spectrophotometer. 2.0   SCOPE: This SOP …

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SOP For Batch Release of Finished Product

Standard Operating Procedure (SOP) for approval and release of Finished Product Batch for moving from the manufacturing site to supply chain/distributors or C&F warehouses.  Procedure for Finished Product Batch Release1.0   PURPOSE: To lay down the procedure for approval and release of the finished product batch. 2.0   SCOPE: This Standard Operating Procedure is applicable for all …

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HVAC System Qualification Protocol (Validation)

Protocol for Qualification and Re-Qualification or Validation of Heating Ventilation and Air Conditioning (HVAC) system for Clean Room. HVAC System Qualification Protocol (Validation) Table of Content – HVAC System Qualification Protocol    S.No. Table of Contents Page 1.0 Protocol Approval 2.0 History Sheet 3.0 Objective 4.0 Scope 5.0 Responsibilities 6.0 Equipment Description 6.1 System Specification …

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