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Operation Procedure for HOIST
Standard Operating Procedure (SOP) for HOIST, containing Operation of L.T ElevatorOperation of Hyundai Elevator, Safety Precautions, etc. SOP for HOIST 1.0 PURPOSE: The purpose of this SOP is to define the procedure for the operation of the hoist. 2.0 SCOPE: This procedure is applicable to the operating procedure of Hoists at […]
SOP for Operation and Cleaning of Colloid Mill
Standard Operating Procedure for operation and cleaning of the colloid mill. contains Checks & Precautions, Cleaning procedure for product to product changeover, batch to batch changeover, etc. SOP for Operation and Cleaning of Colloid Mill 1.0 Purpose: The purpose of this SOP is to define the cleaning and operating procedure for Colloid Mill. 2.0 […]
Operation and Calibration of Analytical Balance
Standard Operating Procedure (SOP) for operation and calibration of analytical balances. As per USP, balance calibration parameters are Internal adjustments, Linearity, Sensitivity, Repeatability (Uncertainty), and Accuracy, etc. SOP for Analytical Balance: Operation and Calibration 1.0 PURPOSE The purpose of this SOP is to describe the procedure of Operation, Calibration, and Maintenance of Analytical […]
Analytical Solution Stability
Standard Operating Procedure (SOP) for Analytical Solution Stability. Procedure for stability study of solutions such as standard preparation, impurity solution, and system suitability solution, etc. SOP for Analytical Solution Stability 1.0 PURPOSE: The purpose of this SOP is to define the procedure for the solution stability (Use before date determination of solution(s) used […]
SOP and Formats for ETP / STP
Standard Operation Procedure and Formats of ETP Effluent Treatment Plant & Sewage Treatment Plant (STP) are defined below. For SOP, please click. SOP for Effluent Treatment Plant (ETP) and STP Annexure and Formats of ETP and STP 1.0 Daily ETP Performance & Operation Record (ETP Formats / Annexure 1) Date: _______________ […]
SOP for Vendor Management
The manufacturer or supplier who is supplying the material in routine and registered for the supply of specific material after the approval process considered as an approved vendor. Vendor management consists of the Identification, Qualification, Requalification, management of changes at the vendor site, Vendor Audit, Technical Agreement, Deregistration Process, etc. Vendor Management 1.0 […]
Record Retention and Archival Policy
The retention period for the Documents and Records in which record shall be retained /preserved in a facility according to their archival policy. The followings are the records and their recommended archival period. Record Retention and Archival Policy in Pharmaceuticals 1.0 POLICY DOCUMENTS Sr. No. Document / Record Name Record Retention Period / Archival […]
Document Management System
A document is a physical or digital representation of a body of information designed with the capacity (and usually intent) to communicate. Below the Standard Operating System (SOP) for Document Management System. A document may manifest symbolic, diagrammatic or sensory-representational information. Following are some examples, but not limited to. SOP for Document Management System 1.0 […]
Process Validation SOP and Protocol
Process Validation: Establishing documented evidence through collection and evaluation of data from the process design stage to routine production, which establishes scientific evidence and provides a high degree of assurance that a process is capable of consistently yield products meeting pre-determined specifications and quality attributes. SOP and Protocol for Process Validation of Drug Product 1.0 […]
Technology Transfer of Drug Product
Technology transfer/product transfer is a complete documented process that covers the detailed documentation for manufacturing and dispatch of the first batch, received from the parent location or FDD of a new or existing product from a particular site with manufacturing, packaging, and analytical details. SOP on Technology Transfer of Drug Product 1.0 PURPOSE: […]
SOP for Rounding off the Analytical Test Results
Standard Operating procedure (SOP) for rounding off figures, numbers of analytical test results, including assay result rounding off, related substances (RS) result and other laboratory generated quantitative value and their reporting system. SOP for Rounding Off Test Results 1.0 PURPOSE: The purpose of this SOP is to describe the standard for “Rounding off” […]
Microbial Culture Management
A microbial culture (microbiological culture) is a procedure of growing microbial organisms (reproduction) by allowing them to breed in programmed culture medium under controlled laboratory conditions. Microbial cultures are initial and basic diagnostic methods used as a research tool in molecular biology. Microbial Culture Management Standard Operating Procedure (SOP) 1.0 PURPOSE: To lay down the […]
Operation Procedure for HOIST
Standard Operating Procedure (SOP) for HOIST, containing Operation of L.T ElevatorOperation of Hyundai Elevator, Safety Precautions, etc. SOP for HOIST 1.0 PURPOSE: The purpose of this SOP is to define the procedure for the operation of the hoist. 2.0 SCOPE: This procedure is applicable to the operating procedure of Hoists at […]
SOP for Operation and Cleaning of Colloid Mill
Standard Operating Procedure for operation and cleaning of the colloid mill. contains Checks & Precautions, Cleaning procedure for product to product changeover, batch to batch changeover, etc. SOP for Operation and Cleaning of Colloid Mill 1.0 Purpose: The purpose of this SOP is to define the cleaning and operating procedure for Colloid Mill. 2.0 […]
Operation and Calibration of Analytical Balance
Standard Operating Procedure (SOP) for operation and calibration of analytical balances. As per USP, balance calibration parameters are Internal adjustments, Linearity, Sensitivity, Repeatability (Uncertainty), and Accuracy, etc. SOP for Analytical Balance: Operation and Calibration 1.0 PURPOSE The purpose of this SOP is to describe the procedure of Operation, Calibration, and Maintenance of Analytical […]
Analytical Solution Stability
Standard Operating Procedure (SOP) for Analytical Solution Stability. Procedure for stability study of solutions such as standard preparation, impurity solution, and system suitability solution, etc. SOP for Analytical Solution Stability 1.0 PURPOSE: The purpose of this SOP is to define the procedure for the solution stability (Use before date determination of solution(s) used […]
SOP and Formats for ETP / STP
Standard Operation Procedure and Formats of ETP Effluent Treatment Plant & Sewage Treatment Plant (STP) are defined below. For SOP, please click. SOP for Effluent Treatment Plant (ETP) and STP Annexure and Formats of ETP and STP 1.0 Daily ETP Performance & Operation Record (ETP Formats / Annexure 1) Date: _______________ […]
SOP for Vendor Management
The manufacturer or supplier who is supplying the material in routine and registered for the supply of specific material after the approval process considered as an approved vendor. Vendor management consists of the Identification, Qualification, Requalification, management of changes at the vendor site, Vendor Audit, Technical Agreement, Deregistration Process, etc. Vendor Management 1.0 […]
Record Retention and Archival Policy
The retention period for the Documents and Records in which record shall be retained /preserved in a facility according to their archival policy. The followings are the records and their recommended archival period. Record Retention and Archival Policy in Pharmaceuticals 1.0 POLICY DOCUMENTS Sr. No. Document / Record Name Record Retention Period / Archival […]
Document Management System
A document is a physical or digital representation of a body of information designed with the capacity (and usually intent) to communicate. Below the Standard Operating System (SOP) for Document Management System. A document may manifest symbolic, diagrammatic or sensory-representational information. Following are some examples, but not limited to. SOP for Document Management System 1.0 […]
Process Validation SOP and Protocol
Process Validation: Establishing documented evidence through collection and evaluation of data from the process design stage to routine production, which establishes scientific evidence and provides a high degree of assurance that a process is capable of consistently yield products meeting pre-determined specifications and quality attributes. SOP and Protocol for Process Validation of Drug Product 1.0 […]
Technology Transfer of Drug Product
Technology transfer/product transfer is a complete documented process that covers the detailed documentation for manufacturing and dispatch of the first batch, received from the parent location or FDD of a new or existing product from a particular site with manufacturing, packaging, and analytical details. SOP on Technology Transfer of Drug Product 1.0 PURPOSE: […]
SOP for Rounding off the Analytical Test Results
Standard Operating procedure (SOP) for rounding off figures, numbers of analytical test results, including assay result rounding off, related substances (RS) result and other laboratory generated quantitative value and their reporting system. SOP for Rounding Off Test Results 1.0 PURPOSE: The purpose of this SOP is to describe the standard for “Rounding off” […]
Microbial Culture Management
A microbial culture (microbiological culture) is a procedure of growing microbial organisms (reproduction) by allowing them to breed in programmed culture medium under controlled laboratory conditions. Microbial cultures are initial and basic diagnostic methods used as a research tool in molecular biology. Microbial Culture Management Standard Operating Procedure (SOP) 1.0 PURPOSE: To lay down the […]
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