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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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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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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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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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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Chromatography is a laboratory technique for the separation of a mixture. The mixture is dissolved in a fluid called the mobile phase, which carries it through a structure holding another material called the stationary phase. The various constituents of the mixture travel at different speeds, causing them to separate. GOOD CHROMATOGRAPHY PRACTICES 1.0 PURPOSE : The
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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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The purpose of this SOP is to lay down a procedure for entry and exit in laboratory in Quality control department. PROCEDURE: Reference standards : Receive the Reference substances check current lot, material safety data sheet and certificate (If available). Allot a reference number to it as illustrated below. USPRS/A1/1. In this, ‘USPRS’ stands
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The purpose of this SOP is to lay down a procedure for disposal of waste generated in Quality control department. This SOP is applicable to Quality Control Department in Quality Control Department at manufacturing facility of Pharmaceutical Industry. PROCEDURE: All used chemicals, Reagents and analyzed products shall be stored in HDPE containers after making slurry
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This SOP is applicable for Disposal of Empty Chemical Containers, and Solvent Bottles generated in Quality Control Department at manufacturing facility of Pharmaceutical Industry. PROCEDURE: The emptied chemical containers and solvent bottles shall be collected in washing room. The labels of the chemical container shall be crossed by pen or removed; the same shall be
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