QC SOPs

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

SOP on Operation And Calibration Of Karl Fischer Apparatus

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SOP on Operation And Calibration Of Karl Fischer Apparatus

Aim: To provide Procedure on Operation And Calibration Of Karl Fischer Apparatus.Objective: This standard operating procedure explains how to use and calibrate the Karl Fischer apparatus.Responsibility: Chemist/Executive Q.C. for following this procedure.Accountability: The Manager of Quality Control is accountable for overall compliance with this SOP. Procedure: Cleaning Related SOP: SOP for Analysis and Release of … Read more

SOP for HPLC Column Cleaning and their Maintenance

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HPLC Column sop

OBJECTIVE: To lay down a procedure for HPLC Column Cleaning and their Maintenance.SCOPE: This Standard operating procedure shall be applicable to HPLC Column Cleaning and maintenance of different types of HPLC columns used in the Quality Control Laboratory. RESPONSIBILITY: Officer/Execution QC department to follow this procedure.Manager QC department for overall compliance with this SOP. PROCEDURE … Read more

SOP for Operation & Calibration of pH Meter

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1.0 Objective: To lay down the procedure for the Operation & Calibration of pH meter2.0 Scope: This sop of ph meter shall be applicable to the Analytical Development Department in Pharmaceuticals3.0 Reference: In-House4.0 Responsibility: Executive/Officer- Analytical Development5.0 Accountability: Manager-Analytical Development. 6.0 Procedure for pH meter, Make Lab India.:6.1 Cleaning Procedure for pH Meter:6.1.1 Clean the … Read more

SOP for Operation and Calibration of Dissolution Apparatus (Tester)

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1.0 Objective: 1.1 To lay down the procedure for the Operation and Calibration of Dissolution Apparatus (Tester).2.0 Scope: 2.1 This SOP shall be applicable to the Analytical development at Pharmaceutical Analytical Lab.3.0 References: 3.1 In-House SOP of dissolution apparatus 4.0 Responsibility:4.1 AD Executive/Sr. Executive.4.2 To follow the procedure for calibration as per SOP.3.3 To maintain … Read more

SOP for Operation and Calibration of Analytical Balance

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1.0 Objective: 1.1 To lay down the procedure for the Operation and Calibration of Analytical Balance (ISHIDA).2.0 Scope: 2.1 This SOP is applicable for the operation and calibration of Analytical Balance in Analytical Development labs.3.0 References: 3.1 In-house4.0 Responsibility:4.1 Executive/Officer Analytical Development Shall be responsible for the operation and calibration of the analytical balance.5.0 Accountability:5.1 … Read more

SOP for Operation & Calibration of Water bath

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1.0 OBJECTIVE: 1.1 To lay down the procedure for the operation & calibration of water bath2.0 SCOPE: 2.1 This SOP is applicable to Analytical development at Pharmaceutical Lab.3.0 RESPONSIBILITY3.1 Officer/Executive – Analytical Development3.2 Manager-AD for overall compliance with this procedure4.0 ACCOUNTABILITY4.1 Manager-AD 5.0 PROCEDURE 5.1 Operating procedure5.1.1 Ensure that the instrument is clean and within … Read more

SOP for Magnetic Stirrer in Pharmaceutical

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1.0 Purpose: To describe the procedure for cleaning, sterilization, and operation of a Magnetic Stirrer.2.0 Aim: This Standard Operating Procedure is applicable for cleaning, sterilization, and operation of the Magnetic Stirrer.3.0 Responsibility:3.1 The line coordinator shall be responsible to carry out the procedure as per SOP.3.2 In-Charge/ Officer shall be responsible for checking and compliance … Read more

Calibration of HPLC and their Operation SOP

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1.0 Objective: To describe the written standard procedure for the Operation & Calibration of HPLC LC- 2050C2.0 Scope: This SOP is applicable for the Operation & Calibration of HPLC LC-2050C3.0 Reference: In-House, Instrument Manual4.0 Responsibility: 4.1 Officers and Executive – F&D4.1.1 Proper Operation of HPLC, LC- 2050C4.1.2 Calibration as per frequency & method.4.1.3 To give … Read more

SOP for Operation, Calibration of Electronic balance

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1.0 Objective: To lay down a procedure for the operation, calibration, and cleaning of the Electronic balance.2.0 Scope: This SOP is applicable for the operation & calibration of electronic balance in the Quality Control Department.3.0 Responsibility: Officer, Executive – Quality Control Department.Head – Quality Control Department 4.0 Procedure for Electronic balance:4.1 Operation4.1.1 Ensure the Calibration … Read more

SOP for Glassware Cleaning in QC Lab

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1.0 Purpose: The purpose of this SOP for cleaning the glassware.2.0 Scope: This standard operating procedure is applicable to glassware in the Quality Control department at pharmaceuticals.3.0 ResponsibilityOfficer to implement this procedureHead QC/Executive – Responsible for overall compliance with this SOP.4.0 AccountabilityIn charge – Quality Control 5.0 Procedure5.1 Send the used glassware for cleaning after … Read more

Method Validation of Analytical Procedures | SOP AMV (ICH Q2 (R1))

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Objective: To lay down procedures for validation of Analytical Procedures to be followed in the laboratory. The AMV (Analytical method Validation) aims to demonstrate that it is appropriate for the purpose.Scope: This SOP is applicable in Analytical Research and Development Laboratory (ADL) for validation or verification of analytical procedures at the Pharmaceutical Quality control laboratory. … Read more

SOP for Retesting and Resampling of Raw materials

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SOP for Retesting and Resampling of Raw materials

1.0 Purpose: The purpose of this SOP is to provide instruction for the Retesting and Resampling of raw materials and intermediates.2.0 Objective: To provide a documented procedure for Retesting and Resampling of raw materials and intermediates.3.0 Scope: This procedure is applicable for the Retesting and Resampling of raw materials and intermediates in the QC department.4.0 … Read more

Procedure for investigation of Out of Specification (OOS) and SOP Formats

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1.0 Purpose: To lay down the procedure for handling, investigating, and reporting of Out of Specification (OOS) results obtained during laboratory testing. This procedure provides guidance to assure that the investigations are conducted in a timely manner with appropriate depth and are supported by the necessary documentation to perform root cause analysis as appropriate. 2.0 … Read more

SOP on Operation and Cleaning of the Decontamination Autoclave

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1.0 Purpose: To lay down the procedure for the operation and cleaning of the decontamination autoclave.2.0 Aim: This Standard Operating Procedure is applicable for the operation and cleaning of the decontamination autoclave, at the Production facility.3.0 Responsibility:3.1 Officers/ Sr. Officers shall be responsible to do the process.3.2 Manager Production shall be responsible for the training … Read more

Annexure for Decontamination Autoclave

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The autoclave is most commonly used for the decontamination of the laboratory. It works on killing the micro-organism by applying high-temperature steam per predetermine criteria. The attached annexure for the different processes is given below: Equipment:    Decontamination Autoclave                                  Process:   Vacuum leak test Annexure-1 Set parameters 1 Pre Vacuum -0.700 2 Delay before hold 3 Min … Read more