Standard Operating procedure on SOP on Temperature Mapping in RM, PM, FG, and Control sample Area 1.0 Objective: To Lay down the Procedure for Temperature Mapping in PM, RM, FG, and Control Sample area (Storage Area).2.0 Scope: 2.1 This SOP shall apply to all storage areas in Pharmaceutical industries.3.0 Reference: In –House 4.0 Responsibility:4.1 RM, … Read more
Learn about Standard operating procedures on Preventive Maintenance of Auto Coater machines in Pharmaceutical industries. 1.0 Objective: To lay down a procedure for Preventive Maintenance of Auto Coater. 2.0 Responsibility: 2.1 Operator, and Officer to perform the preventive maintenance activities as per the respective SOP.2.2 Executives (Eng.Dept.) to prepare and comply with the preventive maintenance … Read more
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
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
Standard operating procedure for Microbiological Testing of In-Process Packing Material, SOP for Bioburden Test. I.0 Purpose: This SOP outlines the steps for conducting Microbiological Testing of In-Process Packing Material. 2.0 Scope: This SOP is applicable for the Microbiological Testing of In-Process Packing Material. 3.0 Responsibilities: All Quality Control personnel are responsible for adhering to and … Read more
Standard Operating Procedure for Operating and Validating Anaerobic Systems in Pharmaceutical Microbiology Laboratory. 1.0 Purpose: This document outlines the step-by-step procedure for operating and Validating Anaerobic Systems. 2.0 Scope: This SOP pertains to the operation and validation of the Anaerobic System Mark III (Hi-Media) within the Microbiology Department. 3.0 Responsibilities: Microbiologist: Responsible for implementation of … Read more
1.0 Objective: The Purpose of this SOP is to lay down the procedure for the Operation and cleaning of the Domino Thermal Inkjet Printer. 2.0 Scope: This SOP is applicable for the Operation and Cleaning of the Domino Thermal Inkjet Printer at the manufacturing facility in Pharmaceuticals. 3.0 Responsibility:3.1 Operator Production shall be responsible for … Read more
1.0 Objective: The purpose of this SOP is to lay down the procedure for the Carton 2D Barcode Printing Machine. 2.0 Scope: This SOP is applicable for the Operation of a Carton 2D Barcode Printing Machine in a Manufacturing facility in Pharmaceuticals. 3.0 Responsibility:3.1 Operator Production shall be responsible for the operation of the Carton … Read more
Automatic Cartoning Machine is used for Packing blisters/Strips inside the carton in secondary packing areas in Pharmaceuticals. 1.0 Purpose: The purpose of this standard operating procedure is to lay down the procedure for Operation and Cleaning of Automatic Cartoning Machine (CP-150). 2.0 Scope: This SOP is applicable to the Operation and Cleaning of an Automatic … Read more
Standard Operating Procedure for Operating and Validating a Biosafety Cabinet 1.0 Objective: The purpose of this procedure is to outline how to use and verify the functionality of a Biosafety Cabinet. 2.0 Scope: This procedure covers the usage and internal validation of a Biosafety Cabinet. 3.0 Responsibilities: Microbiologist: Responsible for using, validating, and maintaining the … Read more
Standard Operating Procedure for Operating and Cleaning a Vortex Mixer in the Microbiology Department. I.0 Purpose: The purpose of this SOP is to provide guidelines for the proper operation and cleaning of the Vortex mixer. 2.0 Scope: This procedure applies to the Microbiology section of the Quality Control Department. 3.0 Responsibilities: 3.1 Quality Control Department … Read more
The Antibiotic Zone Reader quickly and accurately helps figure out how strong antibiotics are by measuring the size of the zone where bacteria can’t grow in a Petri dish. 1.0 Objective: The objective of this Standard Operating Procedure is to provide a written procedure for the operation and calibration of the Antibiotic Zone Reader. 2.0 … Read more
Standard Operating Procedure (SOP) for Operation and Calibration of Heating Block 1.0 Objective: The objective of this Standard Operating Procedure is to lay down the procedure for operating and calibrating the Heating Block. 2.0 Scope: This SOP covers the operation and calibration of the Heating Block in the microbiology Lab. 3.0 Responsibility: Microbiologist: Responsible for … Read more
Standard Operating Procedure Operation and Validation of Laminar Air Flow Hood 1.0 Objective: To provide a written procedure for the operation and validation of Laminar Air Flow Hood. 2.0 Scope: This SOP covers the operation and validation (in-house) of Laminar Air Flow Hood. 3.0 Responsibility: Microbiologist: To perform or implementation of this SOPQA Officer/QAM: For … Read more
Standard Operating Procedure for Operating a Centrifuge Machine, This Standard Opеrating Procеdurе (SOP) provides еssеntial procedure and operation of the Centrigue machine. 1.0 Objective: The primary aim of this guideline is to establish the step-by-step process for effectively using the Centrifuge Machine. 2.0 Scope: This Standard Operating Procedure (SOP) outlines the procedure for the proper … Read more
SOP for Colony Counter is an essential step towards maintaining the Functioning and integrity of instruments used in the Pharmaceutical microbiology section. 1.0 Objective: To establish a written procedure for the operation and calibration of the Colony Counter. 2.0 Scope: This SOP covers the process of operating and calibrating the Colony Counter. 3.0 Responsibility: Microbiologist: … Read more