Quality Control SOP

SOP for Preparation and Validation of Excel Spreadsheet

IT

OBJECTIVE: To define the procedure for Preparation and Validation of Excel Spreadsheets used for calculation in Quality control department. SCOPE: This SOP is applicable for preparation and validation of excel spreadsheet in Q.C. laboratory at manufacturing facility of XXX. RESPONSIBILITY: IT Department: Responsible for password protection and read-only access of excel spreadsheet. Quality Control: Responsible …

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SOP For Operation, Maintenance And Calibration Of Ultrasonic Water Bath

Quality Control

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

Quality Control, SOP

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

Quality Control

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 for Polarimeter

SOP

Purpose: The purpose of this SOP is to describe the procedure for operation, cleaning, and calibration of the polarimeter.    Scope: This SOP  is applicable to the polarimeter available in the Quality control laboratory at the pharmaceutical drug manufacturing plant. Make: … Model:…. Responsibilities – SOP for Polarimeter: The Analyst shall be responsible for: Operate …

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SOP on Operation and Calibration of Melting Point Apparatus

Quality Control

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 BMR & BPR Review

Quality Assurance

Standard Operating Procedure (SOP) for Review of Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) in the pharmaceutical manufacturing plant. A detailed checklist for review of BMR and BPR for Draft Copy as well as  Filled Copy of Batch Manufacturing/Packing Records.  Procedure for BMR & BPR Review 1.0       PURPOSE: The purpose of …

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SOP of Maintenance, Storage and Usage of the Primary Standards

Quality Control

The purpose of this SOP is to describe the procedure for the maintenance storage and usage of the Primary standards. This SOP is applicable for all primary standards, used in Quality Control Department at manufacturing facility of Pharmaceutical Industry PROCEDURE: Whenever any primary standard received from supplier, check whether the sealing of the bottle is …

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