1.0 PURPOSE: To lay down a procedure for preventive maintenance of analytical instruments. 2.0 SCOPE: This procedure is applicable for preventive maintenance of analytical instruments such as HPLCs and GCs available in the quality control
1.0 PURPOSE: To provide a procedure for stability studies of finished products which includes Receipt of samples, Incubation of sample and withdrawal of sample. 2.0 SCOPE: This procedure for stability studies of finished products is
1.0 PURPOSE: To lay down a procedure for management of water quality. 2.0 SCOPE: This procedure for management of water quality is applicable for sampling, testing, approval and rejection of different types of water used
1.0 PURPOSE: To lay down the procedure for personal protective equipment selection and usage. 2.0 SCOPE: This procedure for personal protective equipment selection and usage is applicable for all employees of (Company name). 3.0 DEFINITIONS:
1.0 PURPOSE: To define the procedure for disposal and handling of waste & hazardous waste. 2.0 SCOPE: This procedure for disposal and handling of waste & hazardous waste is applicable at (Company name). 3.0 DEFINITION:
1.0 PURPOSE: To lay down procedure for conducting Acceptable Quality Level (AQL) for products at various stages; including Compression, Coating and Capsule filling. 2.0 SCOPE: This procedure conducting Acceptable Quality Level (AQL) is applicable to
1.0 PURPOSE: To lay down the procedure for cleaning of area when not in use. 2.0 SCOPE: This procedure for cleaning of area when not in use is applicable in (Company name). 3.0 DEFINITIONS: Nil.
1.0 PURPOSE: To lay down the procedure for cleaning of new equipment. 2.0 SCOPE: This procedure for cleaning of new equipment is applicable in Production Injectable, Warehouse and Production OSD area at (Company name). 3.0
1.0 PURPOSE: To lay down the procedure for the recording of burning hours of UV lamps. 2.0 SCOPE: This procedure applicable for recording of burning hours of UV lamps at (Company name). 3.0 DEFINITIONS: Nil.
1.0 PURPOSE: To lay down the procedure for operation and cleaning of emergency eye / face wash station. 2.0 SCOPE: This procedure for operation and cleaning of emergency eye / face wash station is applicable
1.0 PURPOSE: To lay down the Procedure for Monitoring the Lux level. 2.0 SCOPE: This procedure for monitoring the Lux level is applicable at (Company name). 3.0 DEFINITIONS: Nil. 4.0 RESPONSIBILITY: 4.1 Engineering personnel shall
1.0 PURPOSE: To lay down a procedure for Operation and cleaning of Tablet Hardness Tester 2.0 SCOPE: This procedure covers the operation and cleaning of Tablet Hardness Tester, which is used in Quality Assurance department
1.0 PURPOSE: To provide the procedure for operation and cleaning of vacuum pump used in Quality control laboratory. 2.0 SCOPE: This procedure is applicable for operation and cleaning of vacuum pump used in (Company name).
1.0 PURPOSE: To lay down a procedure for operation, cleaning and calibration of Media Preparator. 2.0 SCOPE: This procedure covers the operation, cleaning and calibration of Media Preparator used in Quality Control department of (Company
1.0 PURPOSE: To lay down a procedure for Operation, cleaning and calibration of KF Coulometer with thermoprep oven. 2.0 SCOPE: This procedure covers the operation, cleaning and calibration of KF Coulometer which is used in
1.0 PURPOSE: To lay down a procedure for operation and cleaning of KBr Press apparatus. 2.0 SCOPE: This procedure covers the operation and cleaning of KBr Press apparatus used in Quality Control department of (Company
1.0 PURPOSE: To lay down a procedure for operation and Cleaning of HSD Storage tank. 2.0 SCOPE: This procedure applies for Operation and Cleaning of HSD Storage tank at (Company name). 3.0 DEFINITIONS: Nil. 4.0
1.0 PURPOSE: To lay down the procedure for operation and cleaning of brine chiller. 2.0 SCOPE: This procedure for operation and cleaning of brine chiller is applicable for brine chiller located at (Company name). 3.0
1.0 PURPOSE: To lay down the procedure for operation and cleaning of solvent transfer pump. 2.0 SCOPE: This procedure is applicable for operation and cleaning of solvent transfer pump in Warehouse Department at (Company name).
1.0 PURPOSE: To lay down the Procedure for Recovery test for clean room. 2.0 SCOPE: This procedure applies for Recovery test for clean room at (Company name). 3.0 DEFINITIONS: Nil. 4.0 RESPONSIBILITY: 4.1 Engineering personnel
1.0 PURPOSE: To lay down a procedure for Operation, cleaning and calibration of Vernier caliper. 2.0 SCOPE: This procedure covers the operation, cleaning and calibration of Vernier caliper, which is used in production department of
1.0 PURPOSE: To lay down a procedure for handling of cytotoxic drugs and related wastes. 2.0 SCOPE: This procedure is applicable for handling of cytotoxic drugs and related wastes at (Company name). 3.0 DEFINITIONS: Nil.
1.0 PURPOSE: To lay down a procedure for retesting of Raw material and packing material. 2.0 SCOPE: This procedure is applicable to retesting of Raw material and packing material tested at (Company name). 3.0 DEFINITION:
1.0 PURPOSE: To lay down the procedure for handling of excess material return from user department. 2.0 SCOPE: This procedure is applicable for handling of excess materials return from user department in Warehouse of (company
1.0 PURPOSE: To lay down a procedure for Operation and cleaning of pH and Conductivity Meter. 2.0 SCOPE: This procedure is applicable for operation and cleaning of pH and Conductivity Meter at (Company name). 3.0
1.0 PURPOSE: To lay down the procedure for operation and cleaning of mobile LAF trolley. 2.0 SCOPE: This procedure is applicable for operation and cleaning of mobile LAF trolley in injectable area of (Company name).
1.0 PURPOSE: To lay down a procedure for operation and cleaning of Anaerobic culture Jar used in Quality control laboratory. 2.0 SCOPE: This procedure applicable for operation and cleaning of Anaerobic culture jar used in
1.0 PURPOSE: To lay down a procedure for operation and cleaning of Spinix vortex mixer. 2.0 SCOPE: This procedure applicable for operation and cleaning of Spinix vortex mixer used in quality control laboratory at (Company
1.0 PURPOSE: To lay down the procedure for operation and cleaning of Shipper sealing machine. 2.0 SCOPE: This procedure is applicable for operation and cleaning of Shipper sealing machine at (Company name). 3.0 DEFINITIONS: Nil.
1.0 PURPOSE: To define comprehensive approach to the validation of cleaning procedure for equipment area used in manufacturing process. 2.0 SCOPE: This SOP for cleaning validation in pharma is applicable to cleaning validation at (Company
1.0 PURPOSE: The purpose of the procedure for change control programme in pharma is to have documented procedure for initiation, evaluation, approval and implementation of change control. 2.0 SCOPE: 2.1 This procedure for change control
1.0 PURPOSE: To define the procedure for handling of temporary change control (Planned deviation) during operations. 2.0 SCOPE: This procedure for handling of temporary change control is applicable to all departments in (Company name). The
1.0 PURPOSE: To lay down a procedure for Operation, cleaning and calibration of Scott Volumeter (Density Apparatus). 2.0 SCOPE: This procedure covers the Operation, cleaning and calibration of Scott Volumeter (Density Apparatus), which is used
1.0 PURPOSE: To lay down a procedure for operation and cleaning of Visual inspection board. 2.0 SCOPE: This procedure covers the operation and cleaning of Visual inspection board which is used in Quality Control department
1.0 PURPOSE: To lay down a procedure for operation and cleaning of Biosafety cabinet used in microbiology Laboratory. 2.0 SCOPE: This procedure for operation and cleaning of Biosafety cabinet is applicable to Biosafety cabinet used
1.0 PURPOSE: To lay down a procedure for operation and cleaning of fogger used in microbiology Laboratory. 2.0 SCOPE: This procedure applicable for operation and cleaning of fogger used in microbiology laboratory at (Company name).
1.0 PURPOSE: To establish a standardized procedure for sampling of compressed gasses used in manufacturing process to ensure their quality and compliance with specified requirements. 2.0 SCOPE: This procedure for sampling of compressed gasses used
1.0 PURPOSE: To provide the procedure for operation and cleaning of microscope used in Microbiology laboratory department. 2.0 SCOPE: This procedure for operation and cleaning microscope is applicable at (Company name). 3.0 DEFINITIONS: Nil. 4.0
1.0 PURPOSE: To lay down a procedure for Operation and cleaning of Centrifuge apparatus. 2.0 SCOPE: This procedure covers Operation and cleaning of Centrifuge apparatus which is used in Quality Control department at (Company name).
1.0 PURPOSE: To lay down the procedure for operation, cleaning and calibration of pH meter used in Quality control department. 2.0 SCOPE: This procedure applicable for operation, cleaning and calibration of pH, which is used
1.0 OBJECTIVE: The aim of this cleaning validation protocol is to provide documented evidence that the cleaning procedure designated for each equipment used & unused for products manufactured in manufacturing area are capable of removing
1.0 PURPOSE: To provide a procedure to establish alert and action limits for data obtained in environmental monitoring. 2.0 SCOPE: This procedure is applicable to establish alert and action limits for data obtained in environmental
1.0 PURPOSE: To lay down a procedure for monitoring the Quality of Raw Water based on EPA guidelines. 2.0 SCOPE: This procedure for monitoring the Quality of Raw Water based on EPA guidelines is applicable
1.0 PURPOSE: The purpose of this SOP is to provide procedure for temperature and RH mapping of controlled area and equipment’s. 2.0 SCOPE: This procedure for temperature and RH mapping is applicable to all controlled
1.0 PURPOSE: To lay down the procedure for conduct the mock recall. 2.0 SCOPE: This SOP is applicable to conduct the mock recall of finished product manufactured at (Company name). The scope does not include
1.0 PURPOSE: To lay down the Procedure for dumping challenge test for RO, EDI, Purified water and WFI System. 2.0 SCOPE: This procedure applies for dumping challenge test for RO, EDI, Purified Water and WFI
1.0 PURPOSE: To lay down the procedure for chemical sanitization of potable water storage and distribution system. 2.0 SCOPE: This procedure applies for chemical sanitization of potable water storage and distribution system at (Company name).
1.0 PURPOSE: To lay down the Procedure for Air flow Pattern visual test. 2.0 SCOPE: This procedure applies for Air flow Pattern visual test at (Company name). 3.0 DEFINITIONS: Nil. 4.0 RESPONSIBILITY: 4.1 Engineering personnel
1.0 PURPOSE: To lay down the Procedure for measurement of Air Velocity and air changes per hour. 2.0 SCOPE: This procedure applies for measurement of Air Velocity and air changes per hour at (Company name).
1.0 PURPOSE: To lay down the Procedure for Integrity test of HEPA Filters. 2.0 SCOPE: This procedure applies for Integrity test of HEPA Filters at (Company name). 3.0 DEFINITIONS: Nil. 4.0 RESPONSIBILITY: 4.1 Engineering personnel
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