QC SOPs

SOP for Multi-Stem Thermometer with external sensing probe

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SOP for Multi-Stem Thermometer with external sensing probe

Learn about Standard operating procedures for Multi-Stem thermometers with external sensing probes. Purpose: To lay down procedure for Cleaning & Operating of Multi-Stem Thermometer with external sensing probe. Scope: This procedure is applicable for Multi-Stem Thermometers with external sensing probes used in the company. Responsibility: Accountability: Procedure: Cleaning: Operation of Instrument: Operation: Alarm setting: Precautions: … Read more

SOP for cleaning, operation, and calibration of Muffle Furnace

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SOP for cleaning, operation, and calibration of Muffle Furnace

1.0 OBJECTIVE: 1.1 To lay down a procedure for cleaning, operation, and calibration of Muffle Furnace. 2.0 SCOPE: 2.1 This procedure is applicable for Cleaning, Operation, and calibration of Muffle Furnace in Analytical Development in the Pharmaceutical Laboratory. Instrument Id. : XY/XY/001 Location: Fume Hood 3.0 REFERENCE: 3.1 In-House 4.0 RESPONSIBILITY: 4.1 Officer/ Executive-AD shall … Read more

SOP for estimation of Nickel (IS 12122 -1987)

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Standard working procedure for estimation of Nickel / Standard Working procedure for Nikel estimation by using AAS Methods. Principle: The Nickel content in the sample is determined by aspirating the sample into the flame of an Atomic Absorption Spectrophotometer after pre-concentration. Measured the Absorbance at 232 nm using a Nickel Hollow Cathode Lamp. Limit of … Read more

SOP for Estimation of Sodium (Part 45)

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Standard operating/ Working procedure for Estimation of Sodium, Physical and chemical methods of sampling and test for water and wastewater: Part 45 Sodium Principle: When a sodium-containing solution is put into a flame, the brightness of the light passing through it will decrease depending on how much sodium is in the solution. A special lamp … Read more

SOP for estimation of BORON

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Standard Operating procedure for estimation of BORON in Pharmaceutical and scientific labs. Principle: When Azomethine-H, which comes from condensation of H Acid (8-amino-naptha-1-ol-3.6-disulphonic Acid) and Salicyladehyde, reacts with borate in a watery solution with a pH higher than 6, it a yellow complex that we can measure using a spectrophotometer. To understand the yellow complex … Read more

SOP on Reference Standards and impurities

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SOP on Reference Standards and impurities

Standard Operating Procedure on Procurement, Storage, Usage, and Destruction of Reference Standards and Impurities. In this SOP you will learn about the following: Related SOP: SOP on Withdrawal, Storage, Observation & Destruction of Control Sample 1.0 Objective: 1.1 To lay down a procedure for the Procurement, Storage, Usage, and Destruction of Reference Standards and impurities.2.0 … Read more

SOP on Working Standards- Preparation, Qualification, Usage, Storage, and Destruction

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SOP on Working Standards

Standard operating procedure on Preparation, Qualification, Usage, Storage, and Destruction of Working Standards in Pharmaceutical Labs. Working standard SOP will cover the following points: 1.0 Objective: 1.1 To lay down a procedure for the Preparation, Qualification, Usage, Storage, and Destruction of Working Standards.2.0 Scope: 2.1. This procedure applies to the Preparation, Qualification, Usage, Storage, and … Read more

SOP on Operation of Fume Hood

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SOP on Operation of Fume Hood

Standard operating procedure on Operation of Fume Hood and the Precaution to be taken before its operation. 1.0 Purpose: For proper handling of the instrument and to save the environment of the QC laboratory from hazards and corrosive chemicals in the laboratory. 2.0 Scope: This SOP is applicable to all hazards, volatile and corrosive chemicals … Read more

SOP on Procurement, Usage, and Storage of Primary Standards

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SOP on Procurement, Usage, and Storage of Primary Standards

Standard Operating procedure on Procurement, Usage, and Storage of Primary Standards in Pharmaceutical Quality control Department. 1.0 Objective: 1.1 To lay down a procedure for Procurement, usage, and storage of primary standards 2.0 Scope: 2.1 This procedure is applicable for the Procurement, usage, and storage of primary standards being used in the Quality Control Department … Read more

SOP for Operation and Calibration of Flame Photometer

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SOP for Operation and Calibration of Flame Photometer

Standard operating procedure for Operation and Calibration of Flame Photometer 1.0 Objective: To lay down the procedure for the operation and calibration of the Flame photometer.2.0 Scope: This procedure applies to Flame Photometer instrument installed in the Quality Control Department in Pharmaceutical.3.0 Responsibility: Officer/ Execution responsible for the implementation of this procedure.QC Asst. Manager/ Manager … Read more

SOP for Operation of Digital Griffin Flask Shaker

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Digital Griffin Flask Shaker

Standard Operating Procedure for Operation of Digital Griffin Flask Shaker 1.0 Objective: To provide a procedure for operating the digital Griffin flask shaker. 2.0 Scope: The procedure shall be applied when operating the digital Griffin flask shaker in the Q.C Laboratory. 3.0 Responsibility: QC Executive and any personnel using the equipment to follow the outlined … Read more

SOP for Monitoring and Recording Critical Environmental Parameters of Different classes

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1.0 Purpose: To describe the procedure for monitoring and recording critical environmental parameters of different classes at the production facility. 2.0 Aim: This Standard Operating Procedure is applicable for monitoring and Recording Critical Environmental Parameters such as temperature, relative humidity, pressure differential, and non-viable particle count of a different class (class A, B, C, and … Read more

SOP for Estimation of Mercury using Atomic Absorption Spectroscopy

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SOP for Estimation of Mercury using Atomic Absorption Spectroscopy

Standard Operating Procedure for Estimating Mercury 1.0 Purpose: To lay down the procedure for the Estimation of Mercury using Atomic Absorption Spectroscopy. 2.0 Aim: This Standard Operating procedure is applicable to the Estimation of Mercury using Atomic Absorption Spectroscopy (AAS) in a Pharmaceutical Laboratory. Principle: The method used here, called flameless AAS (Atomic Absorption Spectroscopy), … Read more

SOP on Withdrawal, Storage, Observation & Destruction of Control Sample

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SOP on Withdrawal, Storage, Observation & Destruction of Control Sample

Standard Operating Procedure on Withdrawal, Storage, Observation & Destruction of Control/Retention Sample in Pharmaceuticals. 1.0 Objective: This SOP applies to the withdrawal, storage, observation, and destruction of control samples from production (OSD & Injectable) and Quality control (R.M. Retention) in the pharmaceutical formulation plant. 2.0 Scope: This Standard Operating Procedure applies to the withdrawal, storage, … Read more

SOP on Receipt and Handling of Laboratory Samples

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SOP on Receipt and Handling of Laboratory Sample

1.0 OBJECTIVE: This procedure outlines the steps for receiving and Handling of Laboratory Samples. 2.0 SCOPE: This standard operating procedure pertains to the receipt and Handling of Laboratory Samples. 3.0 RESPONSIBILITY: The Quality Control Executive/Microbiologist is responsible for the implementation of this SOPThe Assistant Manager QC and/or QA Manager are responsible for Overall compliance with … Read more

SOP on Out of Acceptance Limit in Purified Water System

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SOP on Out of Acceptance Limit in Purified Water System

OBJECTIVE: To establish a procedure for action to be taken where critical parameters exceed acceptable limits within the purified water system. SCOPE: This Standard Operating Procedure applies to the generation and distribution of purified water systems. RESPONSIBILITY: Officer, Executive – Engineering Department.Head – Engineering Department for overall compliance to this SOP. ACCOUNTABILITY:Head of Engineering PROCEDURE: … Read more