Field Alert Report (FAR) – Guidance for Submission
Standard Operating Procedure (SOP) and Guideline to describe the process and requirements to file a Field Alert Report (FAR) to the U.S. Food and Drug Administration (FDA) for products distributed/marketed in the United States. SOP for Field Alert Report Submission 1.0 OBJECTIVE This SOP/Guideline describes the process and requirements to file a Field Alert Report […]
Growth Promotion Test and Inhibition Test of Media
Growth promotion test (GPT): Also referred to as fertility or nutritive properties test, which is performed on the media used during different tests like sterility test, microbial limit test, preservative efficacy test to demonstrate that it is capable of supporting the growth of micro-organisms SOP for Growth Promotion Test (USP) 1.0 PURPOSE: To lay down […]
SOP for Handling of Returned Goods / Materials
Standard Operating Procedure (SOP) for Handling of Returned Goods Pharmaceutical Product/Material. These returned goods (materials) either fails to meet the established Specification or returned on the basis of breakage / damaged packaging. Handling of Return Goods (Drug Product / Material) 1.0 PURPOSE: The purpose of this SOP is to define the procedure for handling, redressing, […]
Micro Balance – Operation and Calibration SOP
Standard Operating Procedure (SOP) for Operation, Cleaning, and Calibration of Micro & Semi-Micro Analytical Balance used for weighing WS & Impurities in QC and Research Laboratories. Procedure for Micro Balance Operation and Calibration 1.0 PURPOSE: To describe the procedure for operation, calibration, and performance check of the Micro Balance. 2.0 SCOPE: The SOP applies to […]
Disinfectants & Sanitizer Efficacy Testing Protocol
This protocol/SOP is designed to establish the scientific evidence and demonstrate the efficacy of disinfectants and sanitizing agents against various microorganisms by “Use Dilution or Concentration Method” and “Surface Challenge Test.” Efficacy Evaluation of Disinfectants & Sanitizing Agents Table of Content – Disinfectants Efficacy Protocol: Sr. No Topics 1.0 Protocol Approval 2.0 Purpose 3.0 Scope […]
Drug Product (Finished, Stability) Sampling Procedure
Standard Operating Procedure (SOP) for the sampling/collection of trial, in-process, Finished product, micro, hold time, validation, control, and stability sample. SOP for Drug Product Sampling 1.0 PURPOSE: To define the procedure for the sampling of trial, in-process, finish, micro, hold time, validation, control, and stability sample. 2.0 SCOPE: This SOP is applicable for the collection […]
Handling of Outliers in Near Infrared (NIR) Analysis
Standard Operating Procedure (SOP) & guideline for the Handling of Outliers or aberrant or Out of Specification test result in Near Infrared (NIR) Analysis. Handling of Outliers in Near Infrared (NIR) Analysis 1.0 Purpose: The purpose of this SOP is to describe the procedure for the Handling of Outliers in Near Infrared (NIR) Analysis. 2.0 […]
Guideline for Equipment and System Qualification
Standard Operating Procedure (SOP) and Guideline for preparation of Equipment / System Qualification (URS, IQ, OQ, PQ, FAT, SAT, etc.) documents, execution of Qualification activities, Review and Compilation of data, Assessment and Interpretation of Qualification & validation activity results. Equipment and System Qualification 1.0 Purpose : To lay down the procedure for preparation of Qualification […]
Water Storage Tank – Procedure for Cleaning
Standard Operating Procedure (SOP) for cleaning of the water storage tank (Fire Hydrant, Soft Water, RO water) in the pharmaceutical drug manufacturing plant. Cleaning of the Water Storage Tank 1.0 PURPOSE: The purpose of this SOP is to define the procedure for cleaning the water storage tank. 2.0 SCOPE: This procedure is applicable for all […]
Yield Fixation and Evaluation at Different Processing Stages
Standard Operating Procedure (SOP) for the Calculation of Yield and finalize the Limit at the different stages of drug product processing/manufacturing. This SOP is also applicable for Investigation of out of limit yield obtained during processing. Calculation of Yield and finalize the Limit 1.0 OBJECTIVE : To lay down a procedure for fixation of yield […]
Fire System – Operation and Maintenance SOP
Standard Operating Procedure (SOP) to lay down a procedure to describe the operation and maintenance of the fire System. It also provides a guide to achieve successful fire fighting operations inside the factory premises Procedure for Operation and Maintenance of Fire System 1.0 PURPOSE: To lay down a procedure to describe the operation and maintenance […]
Contract Laboratory Agreement and Testing SOP
Standard Operating Procedure (SOP) for Contract Laboratory Agreement and analytical testing. It covers all the processes of sample sending, sample analysis, and report review of the contract testing laboratory. Contract Laboratory Agreement and Testing 1.0 PURPOSE: To provide guidance to audit and approval of contract analytical testing laboratory as per cGMP requirement. To provide guidance […]
Investigation Tools used in Pharma – SOP & Guideline
The investigation related to quality-related events that occur from cGxPs approved specifications, and/or procedures including but not limited to Protocols, Master Batch Records (MBR), Batch Packaging Records (BPR), breakdowns, facilities, storage, distribution, manufacturing, testing, packaging, warehouse and distribution of drug products. Guideline on Investigation Tools 1.0 PURPOSE: This Standard Operating Procedure (SOP) defines the requirements […]
Handling of Returned Raw & Packing Material – SOP
Standard Operating Procedure (SOP) for Handling of Raw material and Packing Material returned from different sections of the manufacturing/production department to stores/warehouse. Handling of Returned Raw and Packing Material 1.0 Purpose: To define the procedure for handling of Raw Materials and Packaging Material Returned from the production department. 2.0 Scope – SOP for Returned Material: […]
Good Warehousing Practices – SOP & Guideline
Standard Operating Procedure (SOP) and Guideline for Good Warehousing Practices for Raw Material and Packing Materials. The storage of materials in the specified areas according to the classification i.e. poison. Corrosive, Flammable, etc. Good Warehousing Practices 1.0 Purpose: The warehousing of Raw materials/packing material is an important aspect for the following reasons: Proper Identification The […]
Primary and Secondary Standards Handling SOP
Standard Operating Procedure (SOP) for Handling of Primary and Secondary Standards used in Quality Control Laboratory for Analytical Purpose. Handling Procedure for Primary and Secondary Standards 1.0 PURPOSE : The purpose of this SOP is to define the procedure for handling of primary and secondary standards used in analysis. 2.0 SCOPE : This procedure is […]
Purified Water Loop – Operation & Maintenance SOP
Standard Operating Procedure (SOP) for Operation and Maintenance of Purified Water Loop system used in pharmaceutical drug manufacturing plant. Purified Water Loop System 1.0 PURPOSE: The purpose of this SOP is to define the procedure for operation and maintenance of Purified water loop system. 2.0 SCOPE: This procedure is applicable for Purified water loop installed […]
Biosafety Cabinet (ESCO) Operation & Qualification
Standard Operating Procedure (SOP) for Operation, Cleaning and Qualification of Biosafety Cabinet (ESCO) used to storage of Microbiological Media, Cultures and other material used in laboratory. Biosafety Cabinet (ESCO) 1.0 PURPOSE: To lay down the procedure for operation, cleaning and qualification of Biosafety Cabinet (ESCO). 2.0 SCOPE: This Standard Operating Procedure is applicable at Microbiology […]
Continued Process Verification Guideline & SOP
Standard Operating Procedure (SOP) & Guideline for Continued Process Verification. It is the exercise for assuring that during routine production the process remains in a state of control. Procedure for Continued Process Verification 1.0 Purpose : To define procedure for the Continued Process Verification. 2.0 Scope : This guideline is applicable for Continued Process Verification […]
Breakdown Maintenance Procedure and System SOP
Standard Operating Procedure (SOP) and Guideline for handling the breakdown maintenance of Instrument, Equipment, System and Utilities in pharmaceutical Drug Manufacturing Plant. Breakdown Maintenance System 1.0 Purpose : To define procedure for Breakdown Maintenance System. 2.0 Scope : This guideline is applicable to maintenance of all Equipment or Machine. 3.0 Reference, Attachments and Annexures : […]
Blend Uniformity Sampling and Analysis
Standard Operating Procedure (SOP) and Guideline for Sampling, Analysis of Blend Uniformity (BU) samples, and Stratified In-process dosage unit Sampling. Blend Uniformity (BU) – Sampling & Analysis 1.0 Purpose : To define the procedure for the Blend uniformity analysis and Stratified In-process dosage unit Sampling. 2.0 Scope : This guideline is applicable for Blend uniformity […]
Culture Suspension and Cell Enumeration SOP
Standard Operating Procedure (SOP) for Microbial Culture Suspension Preparation, Cell Enumeration, Use, Storage, and Destruction in the microbiology department. Microbial Culture Suspension & Cell Enumeration 1.0 Purpose: The purpose of this SOP is to describe the procedure for the preparation of culture suspension and the enumeration of cells. 2.0 Scope: This SOP is applicable to Bacterial […]
Punches and Dies (Compression m/c) – Handling SOP
Standard Operating Procedure (SOP) and Guideline for Handling of Punches and Dies used in the compression machine for tablet compression. This SOP covers the procedure for procurement, Issuance, Handling, Cleaning, Inspection and Rejection of punches and dies. SOP for Punches & Dies 1.0 Purpose: To define the procedure for procurement, Issuance, Handling, Cleaning, Inspection, and […]
Microbiological Media Management – SOP & Guideline
Standard Operating Procedure (SOP) and Guideline for the Receipt, Storage, Preparation, Growth Promotion Test, use, and Disposal of microbiological media. Microbiological Media Guideline 1.0 Purpose: To define the procedure for the receipt, storage, preparation, growth promotion test, use, and disposal of Microbiological Media used during microbiological analysis. 2.0 Scope: This guideline is applicable to microbiological […]
Investigational Medicinal Product (IMPD) Guideline
Standard Operating Procedure (SOP) & Guideline for manufacturing, packaging (bulk and packed), labeling, testing, release, shipping, and destruction of Investigational Medicinal Product (IMPD Clinical Trial). Investigational Medicinal Product (IMPD Clinical Trial) 1.0 PURPOSE: To describe the procedure for the manufacturing, packaging, labeling, release, shipping, and destruction of Investigational Medicinal Product (IMPD). 2.0 SCOPE: This procedure […]
HPLC Column Management – SOP & Guideline
Standard Operating Procedure (SOP) and Guideline for Receipt, Qualification, Usage, Regeneration, and Discardation of HPLC/UPLC column. Procedure for Handling of HPLC/UPLC Column 1.0 Purpose : To define the procedure for the Receipt, Qualification, Usage, Regeneration, and Discardation of HPLC/UPLC column. 2.0 Scope : This guideline is applicable to all HPLC/UPLC columns received at the quality […]
Quality Assurance in Laboratory (Lab QA) – Guideline
Standard Operating Procedure (SOP) & Guideline to define the role and responsibility of Quality Assurance in Laboratory (as Lab QA) in different activities. Role & Responsibility of Quality Assurance in Laboratory (Lab QA) 1.0 PURPOSE: The purpose of this SOP is to define the role and responsibility of Quality Assurance in the Laboratory (as Lab […]
Primary and Secondary Standards Handling SOP
Standard Operating Procedure (SOP) for Handling of Primary and Secondary Standards used in Quality Control Laboratory for Analytical Purpose. Handling Procedure for Primary and Secondary Standards 1.0 PURPOSE : The purpose of this SOP is to define the procedure for handling of primary and secondary standards used in analysis. 2.0 SCOPE : This procedure is […]
Purified Water Loop – Operation & Maintenance SOP
Standard Operating Procedure (SOP) for Operation and Maintenance of Purified Water Loop system used in pharmaceutical drug manufacturing plant. Purified Water Loop System 1.0 PURPOSE: The purpose of this SOP is to define the procedure for operation and maintenance of Purified water loop system. 2.0 SCOPE: This procedure is applicable for Purified water loop installed […]
Biosafety Cabinet (ESCO) Operation & Qualification
Standard Operating Procedure (SOP) for Operation, Cleaning and Qualification of Biosafety Cabinet (ESCO) used to storage of Microbiological Media, Cultures and other material used in laboratory. Biosafety Cabinet (ESCO) 1.0 PURPOSE: To lay down the procedure for operation, cleaning and qualification of Biosafety Cabinet (ESCO). 2.0 SCOPE: This Standard Operating Procedure is applicable at Microbiology […]
Continued Process Verification Guideline & SOP
Standard Operating Procedure (SOP) & Guideline for Continued Process Verification. It is the exercise for assuring that during routine production the process remains in a state of control. Procedure for Continued Process Verification 1.0 Purpose : To define procedure for the Continued Process Verification. 2.0 Scope : This guideline is applicable for Continued Process Verification […]
Breakdown Maintenance Procedure and System SOP
Standard Operating Procedure (SOP) and Guideline for handling the breakdown maintenance of Instrument, Equipment, System and Utilities in pharmaceutical Drug Manufacturing Plant. Breakdown Maintenance System 1.0 Purpose : To define procedure for Breakdown Maintenance System. 2.0 Scope : This guideline is applicable to maintenance of all Equipment or Machine. 3.0 Reference, Attachments and Annexures : […]
Blend Uniformity Sampling and Analysis
Standard Operating Procedure (SOP) and Guideline for Sampling, Analysis of Blend Uniformity (BU) samples, and Stratified In-process dosage unit Sampling. Blend Uniformity (BU) – Sampling & Analysis 1.0 Purpose : To define the procedure for the Blend uniformity analysis and Stratified In-process dosage unit Sampling. 2.0 Scope : This guideline is applicable for Blend uniformity […]
Culture Suspension and Cell Enumeration SOP
Standard Operating Procedure (SOP) for Microbial Culture Suspension Preparation, Cell Enumeration, Use, Storage, and Destruction in the microbiology department. Microbial Culture Suspension & Cell Enumeration 1.0 Purpose: The purpose of this SOP is to describe the procedure for the preparation of culture suspension and the enumeration of cells. 2.0 Scope: This SOP is applicable to Bacterial […]
Punches and Dies (Compression m/c) – Handling SOP
Standard Operating Procedure (SOP) and Guideline for Handling of Punches and Dies used in the compression machine for tablet compression. This SOP covers the procedure for procurement, Issuance, Handling, Cleaning, Inspection and Rejection of punches and dies. SOP for Punches & Dies 1.0 Purpose: To define the procedure for procurement, Issuance, Handling, Cleaning, Inspection, and […]
Microbiological Media Management – SOP & Guideline
Standard Operating Procedure (SOP) and Guideline for the Receipt, Storage, Preparation, Growth Promotion Test, use, and Disposal of microbiological media. Microbiological Media Guideline 1.0 Purpose: To define the procedure for the receipt, storage, preparation, growth promotion test, use, and disposal of Microbiological Media used during microbiological analysis. 2.0 Scope: This guideline is applicable to microbiological […]
Investigational Medicinal Product (IMPD) Guideline
Standard Operating Procedure (SOP) & Guideline for manufacturing, packaging (bulk and packed), labeling, testing, release, shipping, and destruction of Investigational Medicinal Product (IMPD Clinical Trial). Investigational Medicinal Product (IMPD Clinical Trial) 1.0 PURPOSE: To describe the procedure for the manufacturing, packaging, labeling, release, shipping, and destruction of Investigational Medicinal Product (IMPD). 2.0 SCOPE: This procedure […]
HPLC Column Management – SOP & Guideline
Standard Operating Procedure (SOP) and Guideline for Receipt, Qualification, Usage, Regeneration, and Discardation of HPLC/UPLC column. Procedure for Handling of HPLC/UPLC Column 1.0 Purpose : To define the procedure for the Receipt, Qualification, Usage, Regeneration, and Discardation of HPLC/UPLC column. 2.0 Scope : This guideline is applicable to all HPLC/UPLC columns received at the quality […]
Quality Assurance in Laboratory (Lab QA) – Guideline
Standard Operating Procedure (SOP) & Guideline to define the role and responsibility of Quality Assurance in Laboratory (as Lab QA) in different activities. Role & Responsibility of Quality Assurance in Laboratory (Lab QA) 1.0 PURPOSE: The purpose of this SOP is to define the role and responsibility of Quality Assurance in the Laboratory (as Lab […]
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