Rubber Stereos : SOP for Procurement, Handling & Destruction
Standard Operating Procedure (SOP) for the identification of requirement, procurement, handling, issuance, and destruction of Rubber Stereos used for batch details overprinting of various products. SOP FOR RUBBER STEREOS 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for identity, procuring, handling, issuance, and destruction of rubber stereos […]
Stability Study Samples Withdrawal & Analysis SOP
Standard Operating Procedure (SOP) for withdrawal and analysis of Stability Study Samples (Finished Drug Product) from stability chambers. Withdrawal and Analysis of Stability Study Samples 1.0 PURPOSE: The purpose of this SOP is to define the procedure for Withdrawal and Analysis of Stability Study samples from the stability chamber. 2.0 SCOPE: This SOP is applicable […]
Procedure for Fumigation of Production Area
Standard Operating Procedure (SOP) for Fumigation of the Production area by using Virosil at pharmaceutical drug manufacturing plants. Fumigation in Production Area 1.0 PURPOSE: To lay down a procedure for the fumigation of the production area. 2.0 SCOPE: This standard operating procedure is applicable to the production area in pharmaceutical drug manufacturing plants. 3.0 RESPONSIBILITY […]
Metal Detector – SOP for Cleaning and Operation
Standard Operating Procedure (SOP) for Operation and Cleaning of Metal Detector and Combo Metal Detector cum Deduster used during the manufacturing of drug products in pharmaceuticals. SOP for Metal Detector / Deduster 1.0 PURPOSE: The purpose of this SOP is to describe the cleaning and operation of metal detector and digital combo metal detector cum […]
Mechanical Stirrer – SOP for Cleaning and Operation
Standard Operating Procedure (SOP) for cleaning and operation of Mechanical Stirrer used in granulation at drug product manufacturing in pharmaceuticals. SOP for Cleaning and Operation of Mechanical Stirrer 1.0 PURPOSE: The purpose of this SOP is to lay down the cleaning and operation procedure for Mechanical Stirrer. 2.0 SCOPE: This SOP is applicable for the […]
Batch Processing – SOP & General Check Points
.perating Procedure (SOP) for General Check Point during Drug Product Batch Processing in the pharmaceuticals drug manufacturing plant. General Checks and Precautions During Processing of Batch 1.0 PURPOSE: The purpose of this SOP is to lay down the procedure for General Checks & Precautions during Processing of Batch. 2.0 SCOPE: This SOP is applicable for […]
Non-Recoverable Recovery – Handling & Destruction
Standard Operating Procedure (SOP) for handling and destruction of Non-Recoverable Recovery generated during the processing of pharmaceutical drug products. Handling and Destruction of non-recoverable Recovery 1.0 PURPOSE: The purpose of this SOP to lay down the procedure for handling and destruction of non-recoverable Recovery. 2.0 SCOPE: This SOP is applicable for followings, Handling and destruction […]
Stability Study Protocol and Specification – SOP
Standard Operating Procedure (SOP) for preparation, Issuance, and Execution of Stability Study Protocol, Analytical Template, and Specification of Drug Product. Stability Study Protocol, Template & Specification Preparation 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for the preparation of the stability study protocol/template/Specification in the Quality Control department. […]
Muffle Furnace – Operation and Calibration SOP
Standard Operating Procedure (SOP) for Operation and Calibration check of muffle furnace installed in quality control lab for analysis of sulfated ash, loss on ignition (LOI), etc. SOP for Muffle Furnace 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for Operation and Performance Check procedure of Muffle Furnace and general practices […]
Vacuum Oven – Operation and Calibration SOP
Standard Operating Procedure (SOP) for Operation and Calibration of vacuum oven used in quality control laboratory and R&D in pharmaceuticals. SOP for Vacuum Oven 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for the Operation and Calibration of Vacuum Oven. 2.0 SCOPE: This SOP is applicable for the […]
Dynamic Pass Box – Operation, Cleaning & Qualification
Standard Operating Procedure (SOP) for Operation, Cleaning, and Qualification of Dynamic Pass Box used in the pharmaceutical manufacturing plant. Dynamic Pass Box used for the transfer of material from one area to another in isolation by means of mechanical/electromagnetic door interlocking process that ensures opening of only one door at a time. This process helps […]
Stability Chamber – Operation, Cleaning and Performance check
Standard Operating procedure (SOP) for Operation, Cleaning, and Performance Check/Calibration of Stability chamber (Oven) used for the stability study of drug products. Handling of Stability Chamber/Oven 1.0 Purpose: The purpose of this SOP is to describe the procedure for qualification and monitoring of the stability chamber/oven. 2.0 Scope: This procedure is applicable to the stability […]
Operation and Maintenance of Milli Q Water System
Standard Operating Procedure (SOP) for Milli Q Water purification system for its operation, and general maintenance procedure. SOP for Milli Q Water System 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the operation and maintenance procedure of the Milli Q Water System. 2.0 SCOPE – SOP for Milli Q Water […]
Work Permit System in Pharma – SOP and Formats
Standard Operating Procedure (SOP) for Work Permit System in Pharmaceutical drug manufacturing plant. The work permit system is a formal written procedure used to control the hazards in non-routine work. The different work permit highlights the relevant hazards and precaution to be taken for the respective work before starting the activity. Procedure for Work Permit […]
Environment Health & Safety (EHS) Policy
Standard Operating Procedure for Environment, Health & Safety (EHS) Policy and procedure/practices at pharmaceutical drug manufacturing plants. Procedure / Policy: Environment, Health & Safety (EHS) 1.0 PURPOSE: The objective of the procedure is to define the company goal and driven procedures with respect to the top management. Establish the Environment, Health & Safety Management System […]
New Product Introduction (Risk Evaluation)
This SOP provides guidance to evaluate the potential of the proposed new product for cross-contamination and assessment of the containment approach required to manufacture the new product at Manufacturing and Packaging Facilities. For existing products, Quality Risk Management for Cross-contamination shall be performed as per SOP “Prevention of cross-contamination, Mix up and Microbial Contamination” for […]
UPLC System Calibration Procedure
Calibration Procedure / SOP for Ultra Performance Liquid Chromatography (UPLC) System. UPLC can be regarded as a new direction for liquid chromatography. UPLC refers to ultra-performance liquid chromatography, which improves in three areas: “speed, resolution, and sensitivity”. This Procedure is applicable for Waters Make UPLC – Aquity, UPLC – H Class, Thermo Make U-HPLC Systems, […]
LOD Oven – Operation and Maintenance SOP
Standard Operating Procedure (SOP) for operation and maintenance of the Oven used to determine the Loss on Drying (LOD) in the Quality Control Department. Loss on drying (LOD) is the loss of weight expressed as percentage w/w resulting from water and volatile matter of any kind that can be driven off under specified condition. SOP […]
Flame Photometer – Operation and Calibration SOP
Standard Operating Procedure (SOP) for Operation, Cleaning, and Calibration of Flame Photometer used in inorganic chemical analysis to determine the concentration of certain metal ions, among them sodium, potassium, lithium, and calcium. SOP for Flame Photometer 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the operation and calibration of the […]
Cross Contamination, Mix-Ups & Microbial Contamination
Standard Operating Procedure (SOP) and Detailed Risk Assessment approach for Prevention of Cross Contamination, Mix-ups, and Microbial Contamination. Prevention of Cross Contamination, Mix-Ups & Microbial Contamination 1.0 PURPOSE: The purpose of this procedure is to ensure that the manufacture of all finished drug products and Active Pharmaceutical Ingredients is accompanied by risk-based approaches and controls […]
Sieve Shaker – Operation and Cleaning SOP
Standard Operating Procedure (SOP) for Operation and Cleaning of Electromagnetic Sieve Shaker which is used to determine the particle size of pharmaceutical starting material (API and Excipients). SOP for Electromagnetic Sieve Shaker 1.0 Purpose: The purpose of this SOP ( Standard Operating Procedure) is to describe the operation of Electromagnetic sieve shaker. 2.0 Scope: This […]
Good Documentation Practices – SOP & Guideline
Standard Operating Procedure (SOP) cum Guideline for Good Documentation Practices for cGxP documents (Electronic and Handwritten) Pharmaceutical Drug Manufacturing Plants. Guideline for Good Documentation Practices 1.0 PURPOSE: This Standard Operating Procedure (SOP) defines the requirements for the compliant, consistent, and accurate completion of Good Documentation Practices. 2.0 SCOPE: This standard applies to cGxP documents (electronic […]
Cobb Tester – Operation and Cleaning SOP
Standard Operating Procedure (SOP) for Operation and Cleaning of COBB TESTER used for the analysis of packing/packaging material in the Quality Control Laboratory. SOP for Cobb Tester 1.0 Purpose : The purpose of this SOP is to describe the procedure for the operation and cleaning of Cobb tester. 2.0 Scope : This SOP is applicable […]
Calibration of HPLC System – SOP and Format
Standard Operating Procedure (SOP) and Format/Protocol for Calibration of HPLC system (Parameters are Pressure test, Drift and Noise, Flow Rate Accuracy, Autosampler by carryover check, detector by linearity measurement, etc.) Calibration of HPLC System 1.0 PURPOSE: The purpose of this SOP is to describe the Procedure for Calibration of high-performance liquid Chromatography in Quality Control. […]
Friability Apparatus – Operation & Calibration SOP
Standard Operating Procedure (SOP) for Operation and Calibration of Friability Test Apparatus used to perform the analysis of the Friability Test in solid doses form (Tablet). Procedure For Operation and Calibration of Friabilator 1.0 Purpose: The purpose of this SOP is to describe the procedure for operation and calibration of the Friability apparatus. 2.0 Scope […]
Calibration Program – SOP & Policy
Standard Operating Procedure (SOP) and Policy/Program for Calibration of Instrument, Equipment, and Measuring Device used to measurement, monitoring, and controlling of operation and process in different departments at the Pharmaceutical Drug Manufacturing Plant. Calibration is a set of operations that establish under specified conditions, the relationship between values indicated by a measuring instrument or measuring […]
Out of Specification (OOS) in Packaging Material
Standard Operating Procedure (SOP) for Handling of Out of Specification (OOS) test results in packaging (packing) material so as to ensure that all such test results are properly investigated and closed before taking a decision to release/reject the item, and corrective actions are taken to avoid recurrence. Handling of Out of Specification (OOS) in Packaging […]
New Product Introduction (Risk Evaluation)
This SOP provides guidance to evaluate the potential of the proposed new product for cross-contamination and assessment of the containment approach required to manufacture the new product at Manufacturing and Packaging Facilities. For existing products, Quality Risk Management for Cross-contamination shall be performed as per SOP “Prevention of cross-contamination, Mix up and Microbial Contamination” for […]
UPLC System Calibration Procedure
Calibration Procedure / SOP for Ultra Performance Liquid Chromatography (UPLC) System. UPLC can be regarded as a new direction for liquid chromatography. UPLC refers to ultra-performance liquid chromatography, which improves in three areas: “speed, resolution, and sensitivity”. This Procedure is applicable for Waters Make UPLC – Aquity, UPLC – H Class, Thermo Make U-HPLC Systems, […]
LOD Oven – Operation and Maintenance SOP
Standard Operating Procedure (SOP) for operation and maintenance of the Oven used to determine the Loss on Drying (LOD) in the Quality Control Department. Loss on drying (LOD) is the loss of weight expressed as percentage w/w resulting from water and volatile matter of any kind that can be driven off under specified condition. SOP […]
Flame Photometer – Operation and Calibration SOP
Standard Operating Procedure (SOP) for Operation, Cleaning, and Calibration of Flame Photometer used in inorganic chemical analysis to determine the concentration of certain metal ions, among them sodium, potassium, lithium, and calcium. SOP for Flame Photometer 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the operation and calibration of the […]
Cross Contamination, Mix-Ups & Microbial Contamination
Standard Operating Procedure (SOP) and Detailed Risk Assessment approach for Prevention of Cross Contamination, Mix-ups, and Microbial Contamination. Prevention of Cross Contamination, Mix-Ups & Microbial Contamination 1.0 PURPOSE: The purpose of this procedure is to ensure that the manufacture of all finished drug products and Active Pharmaceutical Ingredients is accompanied by risk-based approaches and controls […]
Sieve Shaker – Operation and Cleaning SOP
Standard Operating Procedure (SOP) for Operation and Cleaning of Electromagnetic Sieve Shaker which is used to determine the particle size of pharmaceutical starting material (API and Excipients). SOP for Electromagnetic Sieve Shaker 1.0 Purpose: The purpose of this SOP ( Standard Operating Procedure) is to describe the operation of Electromagnetic sieve shaker. 2.0 Scope: This […]
Good Documentation Practices – SOP & Guideline
Standard Operating Procedure (SOP) cum Guideline for Good Documentation Practices for cGxP documents (Electronic and Handwritten) Pharmaceutical Drug Manufacturing Plants. Guideline for Good Documentation Practices 1.0 PURPOSE: This Standard Operating Procedure (SOP) defines the requirements for the compliant, consistent, and accurate completion of Good Documentation Practices. 2.0 SCOPE: This standard applies to cGxP documents (electronic […]
Cobb Tester – Operation and Cleaning SOP
Standard Operating Procedure (SOP) for Operation and Cleaning of COBB TESTER used for the analysis of packing/packaging material in the Quality Control Laboratory. SOP for Cobb Tester 1.0 Purpose : The purpose of this SOP is to describe the procedure for the operation and cleaning of Cobb tester. 2.0 Scope : This SOP is applicable […]
Calibration of HPLC System – SOP and Format
Standard Operating Procedure (SOP) and Format/Protocol for Calibration of HPLC system (Parameters are Pressure test, Drift and Noise, Flow Rate Accuracy, Autosampler by carryover check, detector by linearity measurement, etc.) Calibration of HPLC System 1.0 PURPOSE: The purpose of this SOP is to describe the Procedure for Calibration of high-performance liquid Chromatography in Quality Control. […]
Friability Apparatus – Operation & Calibration SOP
Standard Operating Procedure (SOP) for Operation and Calibration of Friability Test Apparatus used to perform the analysis of the Friability Test in solid doses form (Tablet). Procedure For Operation and Calibration of Friabilator 1.0 Purpose: The purpose of this SOP is to describe the procedure for operation and calibration of the Friability apparatus. 2.0 Scope […]
Calibration Program – SOP & Policy
Standard Operating Procedure (SOP) and Policy/Program for Calibration of Instrument, Equipment, and Measuring Device used to measurement, monitoring, and controlling of operation and process in different departments at the Pharmaceutical Drug Manufacturing Plant. Calibration is a set of operations that establish under specified conditions, the relationship between values indicated by a measuring instrument or measuring […]
Out of Specification (OOS) in Packaging Material
Standard Operating Procedure (SOP) for Handling of Out of Specification (OOS) test results in packaging (packing) material so as to ensure that all such test results are properly investigated and closed before taking a decision to release/reject the item, and corrective actions are taken to avoid recurrence. Handling of Out of Specification (OOS) in Packaging […]
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