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User Requirement Specification (URS) Handling SOP

Calibration, cGMP, Checklist, Doc, GLP, Maintenance Sops, Production, Protocol, QA Sop, QC Sop, Quality Control, SOPs, Stores Sops computerized software system, PLCs URS, URS Format, URS Register1 Comment

Standard Operating Procedure (SOP) for Handling of User Requirement Specification (URS) for a computerized system or Instrument / Equipment. User Requirement Specification (URS) is a document that informs the software vendor / software on the users expectations from the software User Requirement Specification (URS) 1.0 PURPOSE: The purpose of this SOP is to establish procedure […]

Analytical Method Validation (AMV) Procedure / Guide

Calibration, cGMP, GLP, Microbiology, QA Sop, QC Sop, Quality Control, SOPs, Validation Accuracy, AMV, Filter paper selection study, Forced degradation, Intermediate Precision, Limit of detection (LOD), Limit of Quantitation (LOQ), Linearity, Mass Balance determination, Method precision, Range, recovery, Repeatability, Robustness, Solution Stability, Specificity, System precision, System suitability test1 Comment

Standard Operating Procedure (SOP) and Guideline for Validation of Analytical Method (AMV). The objective of validation of an analytical Method (AMV) is to demonstrate that it is suitable for its intended purpose. Procedure for Analytical Method Validation (AMV) 1.0 Objective : To lay down procedure for validation of Analytical Method (AMV) to be followed in […]

Swab Test analysis of Equipment / Instrument – SOP

cGMP, Microbiology, Production, Production Sop, QA Sop, QC Sop, Quality Control, SOPs, Validation Auto coater swab, FBD swab, Multi mill swab, RMG swab, Sifter swab, Swab Compression Machine, Swab on Equipment, Swab Sampling Point Location1 Comment

Standard Operating Procedure (SOP & Guideline) for swab test analysis. Swab test analysis is being done to avoid chances of cross contamination from one product to another. By this method we assure that the machine / equipment is free from active ingredients of previous product. Procedure for Swab Test Analysis 1.0 Objective : To lay […]

Sampling of Packaging Materials – Procedure

cGMP, Checklist, Checklist / Formats, GLP, QC Sop, Quality Control, SOPs, Stores Sops Primary Packing Material, Sampling of PPM, Secondary Packaging MaterialLeave a Comment

Standard Operating Procedure (SOP) for sampling of packaging materials (i.e. Aluminum Foil Printed & Plain / Aluminum Foil Forming / PVC / PVDC / HDPE Bottle / Glass Bottle/ Cap Child Resistant /Cap Non Child Resistant / PP Cap / Catch Box / Catron / Label etc. Procedure for Sampling of Packaging Materials 1.0 Objective […]

Roller Compactor Machine – Operation & Cleaning

cGMP, Production, Production Sop, QA Sop, SOPs Compactor Machine, Roll CompactorLeave a Comment

Standard Operating Procedure (SOP) for cleaning and operation of Alexander werk GmbH (Germany) make Roller compactor machine. Roller Compactor Machine 1.0 Purpose : The purpose of this SOP is to lay down the cleaning and operation procedure for Roller Compactor. 2.0 Scope : This SOP is applicable for cleaning and operation of Roller compactor WP […]

Volumetric Solution – Preparation and Standardization

cGMP, GLP, QC Sop, Quality Control, SOPs 0.1M Sodium Thiosulphate, 1M Sodium Hydroxide, Ceric Ammonium Sulphate solution, Disodium Edetate solution, Iodine solution, Perchloric Acid solutionLeave a Comment

Standard Operating Procedure (SOP) and Guideline for Preparation and Standardization of Volumetric Solution(s) used during analysis of Raw material and drug product at pharmaceutical quality control department. Preparation & Standardization of Volumetric Solution(s) Advertisement 1.0 Objective : The purpose of this SOP is to describe a procedure for Preparation & Standardization of Volumetric solution. 2.0 […]

Steam Sterilizer – Qualification & Validation Procedure

Calibration, cGMP, Micro Sop, Microbiology, QA Sop, SOPs, Sterile, Validation Autoclave validation Procedure, Biological Challenge Test, Bowie-Dick Test, D Value, Heat Distribution Studies, Heat labile physical indicator, Heat Penetration StudyLeave a Comment

Standard Operating Procedure (SOP) for procedure for Validation / Qualification of Steam Sterilizer used in microbiology laboratories. Validation of Steam Sterilizer 1.0 Purpose: To lay down the procedure for Validation of Steam Sterilizers. 2.0 Scope: This Standard Operating Procedure is applicable at microbiology section of Quality Control department. 3.0 References & Annexures: References: Health Technical […]

BOD Incubator – Cleaning, Calibration, Operation

Calibration, Micro Sop, Microbiology, QA Sop, SOPs, Validation BOD Validation, Cleaning of BOD, Incubator Validation, Temperature MappingLeave a Comment

Standard Operating Procedure (SOP) for Operation, Cleaning and Calibration of Newtronic make BOD Incubator used in microbiology department for analytical activity. BOD Incubator 1.0 Purpose: To lay down the procedure for Operating, Calibration and Cleaning of BOD Incubators Model No.: NEC134 RTSSI. 2.0 Scope: This Standard Operating Procedure is applicable at Microbiology section of Quality […]

Sterilizing and Depyrogenating Tunnel – PQ Protocol

cGMP, Production, Production Sop, Protocol, Research, Sterile Equipment Performance Qualification, Tunnel PQ, Tunnel QualificationLeave a Comment

Performance Qualification (PQ) Protocol for Sterilizing and Depyrogenating Tunnel is to verify that the equipment produces the desired output. Performance qualification (PQ) of the equipment is planned after the successful completion of the installation and operational qualification. PQ Protocol – Sterilizing and Depyrogenating Tunnel Sr. No. ITEM DESCRIPTION PAGE NO. 1.0 PROTOCOLAPPROVAL 2.0 OVERVIEW: 2.1 […]

Air Handling Unit (AHU) Requalification Protocol

cGMP, Environment, Maintenance Sops, Micro Sop, Microbiology, Production, QA Sop, SOPs, Sterile, Validation Air Changes per hour (ACPH), Air Velocity, Airflow Pattern, Decontamination time study, Differential pressure test, filter integrity test, Non- Viable Particle count test, Sound level test, Viable countsLeave a Comment

Protocol For Qualification / Requalification of Air Handling Unit / System (AHU). This protocol describes the procedure for different tests methods, acceptance criteria, requalification criteria and documentation to be used for requalification of Air handling unit (AHU) serving to manufacturing area of Drug Product. Qualification of Air handling unit (AHU) Sr No. Item Description Page […]

Chromeleon software – Operation & Privileges Policy

cGMP, GLP, QA Sop, QC Sop, Quality Control, SOPs CM-Server Installation, Policies Chromeleon software, Policies on data management, Privileges Chromeleon softwareLeave a Comment

Standard Operating Procedure (SOP) for the working in network of Chromatographic system using Chromeleon software. Management of Chromatographic System Control and Privileges Policy in Chromeleon software. Handling Procedure of Chromeleon Software 1.0 Objective : The purpose of this SOP is to describe a procedure for the working in network of Chromatographic system using Chromeleon software. […]

Primary and Secondary Standards Handling SOP

cGMP, GLP, QC Sop, Quality Control, SOPs Primary Standards, Primary Standards Solution, Secondary StandardsLeave a Comment

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

cGMP, Maintenance Sops, SOPs Integrity testing of Vent Filter, Return Line Velocity, Water Leakage Monitoring, Water Tank Vent FilterLeave a Comment

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

Calibration, cGMP, GLP, Micro Sop, Microbiology, QC Sop, Quality Control, SOPs filter integrity test, Operation of Biosafety Cabinet, PAO (Poly alpha olefin) Test, Particle count test, Qualification of Biosafety Cabinet (ESCO), Setting of Biosafety Cabinet (ESCO), Smoke pattern testLeave a Comment

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

cGMP, Production, Production Sop, Protocol, QA Sop, QC Sop, Quality Control, Research, SOPs, Validation Continued Process Verification Tools, Control charts, Critical Process Parameters, Design of the facility, Identification of CPPs and CQAs, Process Design, Process performance qualification (PPQ), Process QualificationLeave a Comment

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 […]

Calibration of Glassware (Laboratory)- Procedure

January 30, 2021 January 25, 2021 pharmabeginers Calibration, cGMP, GLP, Protocol, QA Sop, QC Sop, Quality Control, SOPs Burette Calibration, Pipette Calibration, Volumetric Flask CalibrationLeave a Comment

Standard Operating Procedure (SOP) and Protocol for Calibration of Laboratory Glassware (Class A) like- Volumetric flask, Pipette calibration, Burette calibration used in Quality Control Laboratory for analysis purpose. Glassware Calibration Procedure 1.0 Purpose: The purpose of this SOP is to describe the procedure for calibration of laboratory glassware. 2.0 Scope: This SOP is applicable for […]

Reference Solution – Preparation & Hold Time Study

January 29, 2021 January 29, 2021 pharmabeginers cGMP, GLP, Protocol, QA Sop, QC Sop, Quality Control, SOPs Solution Hold Time, Solution Stability StudyLeave a Comment

Standard Operating Procedure (SOP) for Preparation, Handling and Hold Time Study of Reference Solution. In analytical chemistry, a standard solution is a solution containing a precisely known concentration of an element or a substance. A known weight of solute is dissolved to make a specific volume. It is prepared using a standard substance, such as […]

Analytical Method Transfer (USP 1224) Guideline

January 23, 2021 May 13, 2021 pharmabeginers Audit, cGMP, Checklist, Checklist / Formats, GC, GLP, HPLC, Protocol, QA Sop, QC Sop, Quality Control, SOPs, Validation Analytical Method Validation (AMV) - Flow Chart, Co-validation, Collaborative Type of Method Transfer, Direct Method Transfer, Indirect Method Transfer, Method Transfer approach, Non-Collaborative Method Transfer, Three-Way Approach, Two-Way Approach1 Comment

Analytical Method Transfer (also called ‘Method Transfer’): A documented process that qualifies a laboratory (i.e., the Receiving Unit) to use an analytical test procedure that originated in another laboratory (i.e., the Transferring Unit), thus ensuring that the Receiving Unit has the procedural knowledge and ability to perform the transferred analytical procedure as intended Analytical Method […]

Microscope – Operation & Calibration Procedure

January 20, 2021 January 19, 2021 pharmabeginers Calibration, cGMP, Micro Sop, Microbiology, SOPs, Sterile Microscope Calibration, Microscopy1 Comment

Standard Operating Procedure (SOP) for operation & calibration of digital microscope. A microscope consists of a compound magnifying system in which the observer looks at the first (primary) image with a lens that produces an enlarged secondary (virtual) image. Microscope – Operation & Calibration 1.0 Purpose: To lay down the procedure for operation and calibration […]

Environmental Monitoring Guide – Non Sterile Facility

January 16, 2021 May 31, 2021 pharmabeginers Calibration, cGMP, Micro Sop, Microbiology, QA Sop, SOPs, Sterile, Validation EM Media PreparationLeave a Comment

Guideline (SOP) for risk based Environmental Monitoring (EM) in Non Sterile drug manufacturing facility. Regulatory standards for non-sterile product manufacture and environmental control have not been consistently established, however, EU GMP requires inhalants to be manufactured in an ISO 8 environment and compendia, such as USP <1111> Microbiological Examination of Nonsterile Products. Procedure for Environmental […]

Environmental Monitoring (EM) – New Approach Guide

January 13, 2021 January 7, 2021 pharmabeginers cGMP, Micro Sop, Microbiology, QA Sop, QC Sop, SOPs, Sterile, Validation Contamination Recovery Rates, Cut-off Value Approach, EM Media Preparation for Sterile, Neutralizing agents, Non-Parametric Tolerance, Non-Viable Particulates, Normal Distribution Approach, sampling surfaces for microbial, Sanitization Procedure, Viable Particulates from EU Annex 1, YEASTS AND MOLDS SURVEYS1 Comment

This Guideline applies to routine Environmental Monitoring (EM) activities in classified manufacturing areas for viable and non-viable particulates, aseptic area personnel gown and glove samples, and for utility systems supplying those areas, such as compressed air, process gases, clean steam and water systems ENVIRONMENTAL MONITORING (EM) PROGRAM 1.0 OBJECTIVE : This Global Quality Standard (GQS) […]