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

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

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

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

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

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

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

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

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

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

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

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

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

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