QC SOPs » Page 2 of 3 » Pharmaguddu

SOP for Monitoring and Recording Critical Environmental Parameters of Different classes

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

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

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

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

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

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

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

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)

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

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

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

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

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

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

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))

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