Product Recall Procedure and Format
The drug product recall is a process of removal or correction of marketed products for the reasons relating to deficiencies in quality, safety or efficacy, including labeling considered to be in violation of the laws. SOP for Product Recall 1.0 PURPOSE The purpose of this SOP is Effective and speedy withdrawal/ removal of […]
Change Control Management Procedure (SOP)
Standard operating procedure (SOP) for change control management. Change Control Procedure is a formal controlled documented process by which qualified representatives from appropriate discipline, review, propose and make changes to an approved system. SOP for Change Control Management 1.0 PURPOSE: This standard operating procedure defines the requirements to ensure changes to systems (includes […]
Maintenance of Laboratory Instrument
Standard Operating Procedure (SOP) for maintenance of laboratory instrument i.e. preventive maintenance, breakdown maintenance, etc. SOP for Maintenance of Laboratory Instrument 1.0 Purpose: The purpose of this SOP (Standard Operating Procedure) is to describe the procedure of instrument maintenance and preventive maintenance. 2.0 Scope: This procedure is applicable to the Instruments at […]
SOP for GC Column Receipt, Performance Check and Storage
Standard Operating Procedure (SOP) for GC Columns, Receipt, performance check, usage, and maintenance of Gas Chromatography Column. SOP for GC Column: Receipt, Storage, Performance Check, Uses and Care 1.0 Purpose: The purpose of this SOP is to describe the procedure for the receipt, performance check, usage, and maintenance of GC Column. 2.0 […]
Receipt and Storage of Raw Material
Standard Operating procedure for receipt and storage of raw material. Starting material such as API and excipient required in the manufacturing of drug product. Receipt and Storage of Raw Material 1.0 PURPOSE: The purpose of this SOP is to define the procedure for receipt and storage of raw materials used in various products. […]
SOP for Disintegration Apparatus (DT)
Standard Operating Procedure (SOP) for disintegration apparatus (DT Apparatus) for operation and calibration as per IP containing various calibration parameters. Operation and Calibration of Disintegration Apparatus (DT) 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for operation, calibration, and cleaning of the disintegration apparatus. 2.0 SCOPE: This […]
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 […]
Sampling and AQL of Packing Material
Standard Operating Procedure (SOP) for the sampling of packing material (Primary Packing Material, Secondary Packing Material, and Tertiary Packing Material). Military Standard procedure. Procedure for Sampling and AQL of Packing Material 1.0 PURPOSE: The purpose of this SOP is to define the procedure for sampling and acceptance Quality level of packing materials. 2.0 SCOPE: This […]
Cleaning, Handling and Storage of FBD Bags
Standard Operating Procedure (SOP) for Cleaning, Handling, and Storage of Fluid Bed Dryer FBD Bags for a different group of the drug product in the pharma plant. Procedure for Cleaning, Handling, and Storage of FBD Bags 1.0 PURPOSE: The purpose of this SOP is to define the cleaning, handling, and storage of FBD bags. 2.0 […]
SOP for Status Label in Production
Standard Operating procedure (SOP) for identification and status label/labeling procedure of product, accessories equipment, and various manufacturing areas. Status Label/Labelling Procedure PURPOSE: To lay down the identification and status labeling procedure of Products, Containers, Accessories, Equipment, and Areas. SCOPE: This procedure is applicable to the WIP labels used in Warehouse, Granulation, Compression, Coating, Packing & […]
SOP for Batch Size Determination
Standard Operating Procedure (SOP) for Batch Size Determination according to the chain of production equipment and equipment capacity. Batch Size determination based on the risk assessment. Procedure for Determination of Batch Size 1.0 PURPOSE: This Standard Operating Procedure (SOP) describes in detail the procedure to be followed for the determination of the batch […]
FTIR-Operation and Calibration SOP
Standard Operating Procedure (SOP) for Operation, Calibration, Cleaning, and Maintenance of FTIR (Fourier Transform Infrared Spectrometer). Procedure for Operation and Calibration of FTIR 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the start-up, operation, calibration, and maintenance procedure of the FTIR – Fourier Transform Infrared Spectrophotometer. Visit to copy this […]
SOP for Training Management in Pharma
Standard Operating Procedure (SOP) for Training Management of newly joined as well as an existing employee (staff and workers) working in a cGMP environment in pharmaceuticals. Procedure for Training Management 1.0 PURPOSE: The purpose of this SOP is to describe the procedure to provide the guideline for training (TRN) of employees. 2.0 […]
SOP for Handling of Market Complaint
Standard Operating Procedure (SOP) for Handling of Market Complaint of Finished Pharmaceutical Drug Product. A market/consumer complaint is a notification that the product in commercial distribution- May be in violation of the laws or regulations administered by the FDA. May have caused illness, injury or death. Is alleged to have caused problems not covered by […]
Calibration of Total Organic Carbon (TOC) Analyzer
SOP for Operation and Calibration of Total Organic Carbon (TOC) analyzer. This measurement is proportional to the carbon in the sample. Carbon dioxide shows a unique adsorption spectrum when IR energy passes through it. Operation and Calibration of Total Organic Carbon (TOC) Analyzer 1.0 PURPOSE: To lay down the procedure for Operation […]
Water Analysis SOP as per IP/BP/USP
Standard Operating Procedure (SOP) for Water Sample Analysis as per IP/BP/USP. Procedure for chemical testing and microbiological testing of Raw/Tap water, RO water, and purified water samples. Procedure for Water Analysis (Chemical & Microbiological) 1.0 PURPOSE: To lay down a procedure for analysis of water samples (Chemical and Microbiological Analysis) 2.0 […]
Procedure for using of Molybdenum Kit
Standard Operating Procedure (SOP) for using of Molybdenum Kit, This kit is used to check the content of molybdenum in stainless steel. Procedure for using of Molybdenum Kit 1.0 PURPOSE: The purpose of this SOP is to provide a guideline for carrying out the test of Stainless Steel (SS) surface with the Molybdenum […]
SOP for Line Clearance (LC) of Area and Equipments
Standard Operating Procedure (SOP) for Line Clearance (LC) of the manufacturing area and equipment at the different stages of drug product manufacturing and packing in a pharmaceutical manufacturing plant. Procedure for Line Clearance of Area and Equipment 1.0 PURPOSE : The purpose of this SOP (Standard Operating Procedure) is to describe the procedure […]
SOP for Incident / Deviation Management
Standard Operating Procedure (SOP) for Handling and Management of Incident / Deviation under the Quality Management System (QMS) in a pharmaceutical plant. Handling and Control Procedure for Incident / Deviation 1.0 PURPOSE: This Standard Operating Procedure (SOP) defines the key elements and requirements for reporting, documenting, evaluating, managing and resolving deviations/incidents from cGxPs […]
Sampling and AQL of Packing Material
Standard Operating Procedure (SOP) for the sampling of packing material (Primary Packing Material, Secondary Packing Material, and Tertiary Packing Material). Military Standard procedure. Procedure for Sampling and AQL of Packing Material 1.0 PURPOSE: The purpose of this SOP is to define the procedure for sampling and acceptance Quality level of packing materials. 2.0 SCOPE: This […]
Cleaning, Handling and Storage of FBD Bags
Standard Operating Procedure (SOP) for Cleaning, Handling, and Storage of Fluid Bed Dryer FBD Bags for a different group of the drug product in the pharma plant. Procedure for Cleaning, Handling, and Storage of FBD Bags 1.0 PURPOSE: The purpose of this SOP is to define the cleaning, handling, and storage of FBD bags. 2.0 […]
SOP for Status Label in Production
Standard Operating procedure (SOP) for identification and status label/labeling procedure of product, accessories equipment, and various manufacturing areas. Status Label/Labelling Procedure PURPOSE: To lay down the identification and status labeling procedure of Products, Containers, Accessories, Equipment, and Areas. SCOPE: This procedure is applicable to the WIP labels used in Warehouse, Granulation, Compression, Coating, Packing & […]
SOP for Batch Size Determination
Standard Operating Procedure (SOP) for Batch Size Determination according to the chain of production equipment and equipment capacity. Batch Size determination based on the risk assessment. Procedure for Determination of Batch Size 1.0 PURPOSE: This Standard Operating Procedure (SOP) describes in detail the procedure to be followed for the determination of the batch […]
FTIR-Operation and Calibration SOP
Standard Operating Procedure (SOP) for Operation, Calibration, Cleaning, and Maintenance of FTIR (Fourier Transform Infrared Spectrometer). Procedure for Operation and Calibration of FTIR 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the start-up, operation, calibration, and maintenance procedure of the FTIR – Fourier Transform Infrared Spectrophotometer. Visit to copy this […]
SOP for Training Management in Pharma
Standard Operating Procedure (SOP) for Training Management of newly joined as well as an existing employee (staff and workers) working in a cGMP environment in pharmaceuticals. Procedure for Training Management 1.0 PURPOSE: The purpose of this SOP is to describe the procedure to provide the guideline for training (TRN) of employees. 2.0 […]
SOP for Handling of Market Complaint
Standard Operating Procedure (SOP) for Handling of Market Complaint of Finished Pharmaceutical Drug Product. A market/consumer complaint is a notification that the product in commercial distribution- May be in violation of the laws or regulations administered by the FDA. May have caused illness, injury or death. Is alleged to have caused problems not covered by […]
Calibration of Total Organic Carbon (TOC) Analyzer
SOP for Operation and Calibration of Total Organic Carbon (TOC) analyzer. This measurement is proportional to the carbon in the sample. Carbon dioxide shows a unique adsorption spectrum when IR energy passes through it. Operation and Calibration of Total Organic Carbon (TOC) Analyzer 1.0 PURPOSE: To lay down the procedure for Operation […]
Water Analysis SOP as per IP/BP/USP
Standard Operating Procedure (SOP) for Water Sample Analysis as per IP/BP/USP. Procedure for chemical testing and microbiological testing of Raw/Tap water, RO water, and purified water samples. Procedure for Water Analysis (Chemical & Microbiological) 1.0 PURPOSE: To lay down a procedure for analysis of water samples (Chemical and Microbiological Analysis) 2.0 […]
Procedure for using of Molybdenum Kit
Standard Operating Procedure (SOP) for using of Molybdenum Kit, This kit is used to check the content of molybdenum in stainless steel. Procedure for using of Molybdenum Kit 1.0 PURPOSE: The purpose of this SOP is to provide a guideline for carrying out the test of Stainless Steel (SS) surface with the Molybdenum […]
SOP for Line Clearance (LC) of Area and Equipments
Standard Operating Procedure (SOP) for Line Clearance (LC) of the manufacturing area and equipment at the different stages of drug product manufacturing and packing in a pharmaceutical manufacturing plant. Procedure for Line Clearance of Area and Equipment 1.0 PURPOSE : The purpose of this SOP (Standard Operating Procedure) is to describe the procedure […]
SOP for Incident / Deviation Management
Standard Operating Procedure (SOP) for Handling and Management of Incident / Deviation under the Quality Management System (QMS) in a pharmaceutical plant. Handling and Control Procedure for Incident / Deviation 1.0 PURPOSE: This Standard Operating Procedure (SOP) defines the key elements and requirements for reporting, documenting, evaluating, managing and resolving deviations/incidents from cGxPs […]
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