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
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
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
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
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
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
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
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
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
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
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
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
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
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
The autoclave is playing a vital role in the Microbiology department. Before testing any material, except the sample, all preparations including glassware must be autoclaved for sterilization of the preparations ( free from microbial load ). 1.0 Objective: To lay down standard operating procedure on operation and calibration of autoclave 2.0 Scope: This procedure is applicable to … Read more
1.0 Objective: To lay down a procedure for microbiological monitoring of compressed air used in manufacturing areas.2.0 Scope: This SOP shall be applicable for a total viable aerobic count of compressed air of “O” Zone and Class 10,000 (liquid manufacturing) area at Manufacturing area. 3.0 Responsibility:Execution: Tr. Executive and above –QC DepartmentChecking: Asst. Manager and … Read more