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MLT Method Validation Procedure & Protocol

cGMP, GLP, Micro Sop, Microbiology, Quality Control, SOPs, Validation Inoculum Preparation, Preparation of negative control, Preparation of Positive control, Preparation of test sample, Test for Specified Micro-OrganismsLeave a Comment on MLT Method Validation Procedure & Protocol

The MLT method must be validated before it will be applied when testing a product for resistance to bacteria in order to ensure that the product has no microbial inhibitory characteristics that could lead to false negative results. The MLT Method Suitability Test is known as the title of this validation test. Validation Protocol for MLT […]

Antimicrobial Efficacy Test – Guideline

cGMP, Micro Sop, Microbiology, Protocol, QC Sop, Quality Control, SOPs Efficacy Test, Preservative Effectiveness test, stock culture suspensionsLeave a Comment on Antimicrobial Efficacy Test – Guideline

The Antimicrobial Efficacy Test, also known as the preservative effectiveness test, is a compendial test performed during formulation development and stability testing of a parenteral drug product intended as a multi-dose product. Procedure for Antimicrobial Efficacy Test 1.0   Purpose: The purpose of this SOP is to check the efficacy of antimicrobial efficacy Test.  2.0   Scope: […]

Personal Protective Equipment (PPE) usage

cGMP, Checklist, Environment, GLP, Health & Safety (EHS), Micro Sop, Microbiology, Production, SOPs Face protection, Foot protection, Hand protection, Head protection, PPEs, Protection against fall, protection against noise, Respiratory protection, Skin & body protectionLeave a Comment on Personal Protective Equipment (PPE) usage

Personal protective equipment (PPE) is equipment worn to reduce exposure to hazards that cause serious workplace injuries and illnesses. Chemical, radiological, physical, electrical, mechanical, or other workplace hazards may cause these injuries and illnesses. Gloves, safety glasses, and shoes, earplugs or muffs, hard hats, respirators, or coveralls, vests, and full body suits are examples of […]

Product Dossier Registration Process

Audit, cGMP, Doc, Micro Sop, QA Sop, Quality Control, SOPs Common Technical Document, Comparative Dissolution Profile, Drug Product Registration, product filing, Technology Transfer DocumentLeave a Comment on Product Dossier Registration Process

Product Dossier (CTD): Dossier is a collection of documents on the particular subjects. Any preparation of pharmaceutical product for human use go through the process of reviewing and assessing the dossier of pharmaceutical product which contains details information about administrative, quality, non- clinical and clinical data. This process is governed and permitted by Drug Regulatory […]

Emergency Plan On Site – Safety SOP

cGMP, Checklist, Environment, Health & Safety (EHS), Maintenance Sops, SOPs Chemical spill, flammable or hazardous chemical, Hazard Potential Area, Major fire or explosion, Mock Drills Frequency, natural calamities, Release of toxic, Spillage of Toxic SubstanceLeave a Comment on Emergency Plan On Site – Safety SOP

Standard Operating Procedure for On-site Emergency Plan : The main purpose of the on Site Emergency Plan is for effective mobilization of resources in order to: save lives, rescue victim, minimize injury, timely treatment to the injured personnel, Identify the dead / casualty and minimize the extent of the damage to the resources, inform relatives […]

Good Clinical Practices (GCP) Guideline

cGMP, Doc, QA Sop, SOPs Good Clinical Practices, Serious Breach of GCPLeave a Comment on Good Clinical Practices (GCP) Guideline

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. This guideline provides the procedure for Handling and Reporting of serious breaches of Good clinical practices (GCP). GOOD CLINICAL PRACTICES (GCP) – HANDLING AND REPORTING OF SERIOUS BREACHES 1.0   OBJECTIVE […]

Microbiologist Qualification : SOP & Protocol

cGMP, GLP, Micro Sop, Microbiology, QA Sop, Quality Control, SOPs, Sterile, Validation Microbiologist - Reviewer Qualification, Qualification For BET Testing, Qualification For LBPC Testing, Qualification For MLT Testing, Qualification For Sterility Testing, Re-qualification of MicrobiologistLeave a Comment on Microbiologist Qualification : SOP & Protocol

Standard Operating Procedure (SOP) and Protocol for Microbiologist Qualification (validation) to establish and assure that Microbiologist is capable of performing Microbiological testing in Microbiology Department. Microbiologist Qualification 1.0   PURPOSE : The purpose of this Standard Operating Procedure (SOP) is to lay down the Procedure for Microbiologist Qualification (validation) to establish and assure that Microbiologist is […]

Quality Agreement Technical (Contract Manufacturing)

Audit, cGMP, QA Sop, QC Sop, SOPs Commercial Agreement, Contract Giver, Contract Manufacturer, Investigation, Product Recall, Quality EventLeave a Comment on Quality Agreement Technical (Contract Manufacturing)

Quality Agreement means comprehensive written agreement that defines and establishes the obligations and responsibilities of the Quality Units of each of the parties involved in contract manufacturing of drugs subject to cGMP. Technical Quality Agreement for Contract Manufacturing This “Quality Agreement” is made by and between Contract Giver a Company incorporated under the Companies Act, […]

Depyrogenating Tunnel – Qualification Protocol (PQ)

cGMP, Protocol, Validation Active Air Sampling, Air Flow Pattern Studies, Heat Distribution Studies, Heat Penetration Studies, Passive Air Sampling2 Comments on Depyrogenating Tunnel – Qualification Protocol (PQ)

Performance Qualification Protocol for sterilizing and depyrogenating tunnel Dry Powder Injection Production area. Qualification (PQ) of Sterilizing and Depyrogenating Tunnel 1.0   Objective: The purpose of this protocol is to provide an outline for the qualification of the Sterilizing and Depyrogenating Tunnel by verification of performance attributes such as: The PAO Penetration through installed HEPA Filters, […]

Reference Standard, Working Standard Procedure

cGMP, GLP, QC Sop, Quality Control, SOPs CRS, Impurity Standard, IPRS, USP Reference Standard, USPRS, Working standard, WSLeave a Comment on Reference Standard, Working Standard Procedure

Procedure for Management of Working Standard, Reference Standard, Calibration Standard, Impurity Standard, GC Standard and Primary Standard. Working Standard / Reference Standard Management 1.0   Objective : To lay down procedure for management of Working Standard, Reference Standard, Calibration Standard, Impurity Standard, GC Standard and Primary Standard in Quality Control Department. 2.0   Scope : This SOP […]

Quality Metrics – New FDA Guideline

Audit, Calibration, cGMP, Checklist, Checklist / Formats, Doc, Environment, GLP, Health & Safety (EHS), HPLC, IT SOP, Maintenance Sops, Micro Sop, Microbiology, Production, Production Sop, Protocol, QA Sop, QC Sop, Quality Control, Research, SOPs, Sterile, Stores Sops, Validation Quality Assessment, Quality Review BoardLeave a Comment on Quality Metrics – New FDA Guideline

The term “Quality Metrics” means all those indicators that give an idea of ​​the collective quality characteristics of a certain production site. The number of rejected batches per year compared to the total number of batches produced, or the number of out-of-specification (OOS) results found by a QC lab, and which are then not confirmed […]

Dietary Supplements Recall Guideline

Audit, cGMP, Checklist, Checklist / Formats, Health & Safety (EHS), Production, QA Sop, SOPs, Stores Sops Market Complaint, Mock Recall, Recall of Food ProductLeave a Comment on Dietary Supplements Recall Guideline

Guideline / SOP for Handling procedure to recall the Dietary Supplements from supply warehouse or market in case of a market complaint or defective product supplied in the market. Recall Procedure for Dietary Supplements 1.0   Purpose: This Standard Operating Procedure (SOP) describes in detail the recall procedure for Dietary Supplements. 2.0   Scope: This SOP is […]

Grounding Requirement for Equipment and Building

cGMP, GLP, Health & Safety (EHS), Maintenance Sops, Production, Production Sop, Quality Control, SOPs Building Earthing, Equipment earthingLeave a Comment on Grounding Requirement for Equipment and Building

Guideline (SOP) for grounding static equipment and building, but it is not applicable to transportation equipment, except when equipment is used in the loading or unloading of flammable material. The requirements of this procedure are minimum requirements & it will be expanding if necessary. Requirements for Grounding Equipment and Building 1.0   Purpose: The objective of […]

Microbial Limit Test (MLT) of Non Sterile Product

cGMP, GLP, Micro Sop, Microbiology, Quality Control, SOPs, Sterile MLT TestLeave a Comment on Microbial Limit Test (MLT) of Non Sterile Product

Guideline (SOP) for quantitative enumeration of mesophilic bacteria & fungi that may grow under aerobic conditions and for detecting the presence of specified microorganisms in pharmaceutical raw materials and finished products (Microbial Limit Test – MLT). Microbial Limit Test (MLT) procedure 1.0   Purpose The purpose of this SOP is To lay down the procedure for […]

Microbiological Analysis of Material & Drug Product

cGMP, Micro Sop, Microbiology, QA Sop, SOPs, Sterile Good Microbiology Practices, Microbial AnalysisLeave a Comment on Microbiological Analysis of Material & Drug Product

Procedure & Guideline (SOP) for Microbiological Analysis of Raw Material (API & Excipient), In process sample and Finished drug product in pharmaceuticals. Microbiological Analysis of Drug Product / Material 1.0   Purpose: The purpose of this SOP is to define a procedure for Microbiological analysis of Raw material, in process samples and finished products. 2.0   Scope: […]

« Previous 1 2 3 4 5 6 … 18 Next »

Data Integrity: A Crucial Aspect of Pharmaceutical Quality

December 18, 2023 December 18, 2023 pharmabeginers Blog, cGMP, Doc 211.68(b), audit trail, cGMP quality system, cGMP record, computer or related systems, Data Life cycle, electronic signatures, metadata, reprocessed laboratory chromatography, static and dynamic records, system suitabilityLeave a Comment on Data Integrity: A Crucial Aspect of Pharmaceutical Quality

Data integrity is a fundamental pillar in the field of pharmaceuticals, playing a crucial role in maintaining the quality and safety of medicinal products. In an industry where human lives are at stake, the accuracy and reliability of data are of utmost importance. Therefore, it is imperative for pharmaceutical companies to establish robust systems and […]

Contract Manufacturing (CMO) Management

December 16, 2023 December 16, 2023 pharmabeginers Audit, cGMP, Checklist, QA Sop, SOPs CMO, Common Technical Document, contract agreement, For Cause AuditLeave a Comment on Contract Manufacturing (CMO) Management

Pharmaceutical contract manufacturing refers to the practice of contracting out the production of pharmaceuticals, such as pills, tablets, and capsules, for a third party to consume. Contract Manufacturing (CMO) Management Purpose The purpose of this standard operating procedure is to describe the procedure for Management of Contract Manufacturing service provided by contract Manufacturing Company, which […]

Reagent Solution Preparation Procedure

October 11, 2023 October 11, 2023 pharmabeginers cGMP, GLP, QC Sop, Quality Control, Research Ammonium Acetate Solution, Cobaltous Chloride Colorimetric Reagent, Cupric Sulphate Colorimetric, Ferric Chloride ColorimetricLeave a Comment on Reagent Solution Preparation Procedure

Standard operating procedure (SOP) to prepare the Reagent Solution for chemical analysis in the quality control laboratory General Reagent Solution Preparation 1.0   Objective To lay down the procedure for the preparation of the general reagent solution. 2.0   Scope This SOP is applicable in the Analytical / Quality Control Laboratory for the preparation of reagent solutions 3.0  […]

Quality Manual & Quality Policy in Pharmaceuticals

September 28, 2023 September 28, 2023 pharmabeginers cGMP Leave a Comment on Quality Manual & Quality Policy in Pharmaceuticals

WFIWhat is a Quality Manual (Quality System Manual / QMS Manual? A Quality Manual is a document that was first required by the ISO 9001 standard for Quality Management Systems. A Quality Manual is a top-level document that describes an organization’s Quality Management System (QMS).  It can be used both internally (for employees) and externally […]

Dry Heat Sterilizer (DHS) Validation Protocol

August 10, 2023 August 10, 2023 pharmabeginers cGMP Air Flow Pattern Study, Air velocity measurement, Differential Pressure Monitoring, Endotoxin Challenge Studies, Estimation of  FH Value, Heat Distribution Studies, Integrity Testing of HEPA Filters, Loaded Chamber Heat Penetration Studies, Pre-Qualification Tests, Viable Particle monitoring1 Comment on Dry Heat Sterilizer (DHS) Validation Protocol

oProcedure and protocol for Dry heat sterilizer (DHS) validation, DHS consists of accurately measuring the temp. at critical points within the sterilization chamber throughout the process. Dry heat process generally employs a temperature between 250°C and 400°C for varying time. The sterilizer is required to heat all parts of its load up to the specified […]

Agilent HPLC – Operation & Calibration SOP

July 8, 2023 July 8, 2023 pharmabeginers Calibration, Checklist / Formats, GLP, HPLC, Protocol, QC Sop, Quality Control, SOPs Agilent HPLC Calibration, Agilent HPLC Infinity Series, Agilent HPLC Operation, Auto injector calibration:, Auto Injector Linearity, Cleaning of HPLC, Flow calibration, Gradient Pump Accuracy, HPLC Calibration, Injection Carry Over, Injection volume accuracy:Leave a Comment on Agilent HPLC – Operation & Calibration SOP

uidance is provided on general procedure applicable for operation and calibration of High Performance Liquid Chromatography (HPLC) taking Agilent HPLC Infinity Series (Quaternary Channel) system as an example. Parameters to be considered for calibration of Agilent HPLC. Agilent HPLC – Operation & Calibration Procedure  1.0   Purpose The purpose of this SOP is to describe the […]

MLT Method Validation Procedure & Protocol

June 29, 2023 June 29, 2023 pharmabeginers cGMP, GLP, Micro Sop, Microbiology, Quality Control, SOPs, Validation Inoculum Preparation, Preparation of negative control, Preparation of Positive control, Preparation of test sample, Test for Specified Micro-OrganismsLeave a Comment on MLT Method Validation Procedure & Protocol

The MLT method must be validated before it will be applied when testing a product for resistance to bacteria in order to ensure that the product has no microbial inhibitory characteristics that could lead to false negative results. The MLT Method Suitability Test is known as the title of this validation test. Validation Protocol for MLT […]

Antimicrobial Efficacy Test – Guideline

June 20, 2023 June 20, 2023 pharmabeginers cGMP, Micro Sop, Microbiology, Protocol, QC Sop, Quality Control, SOPs Efficacy Test, Preservative Effectiveness test, stock culture suspensionsLeave a Comment on Antimicrobial Efficacy Test – Guideline

The Antimicrobial Efficacy Test, also known as the preservative effectiveness test, is a compendial test performed during formulation development and stability testing of a parenteral drug product intended as a multi-dose product. Procedure for Antimicrobial Efficacy Test 1.0   Purpose: The purpose of this SOP is to check the efficacy of antimicrobial efficacy Test.  2.0   Scope: […]

Personal Protective Equipment (PPE) usage

March 20, 2023 March 20, 2023 pharmabeginers cGMP, Checklist, Environment, GLP, Health & Safety (EHS), Micro Sop, Microbiology, Production, SOPs Face protection, Foot protection, Hand protection, Head protection, PPEs, Protection against fall, protection against noise, Respiratory protection, Skin & body protectionLeave a Comment on Personal Protective Equipment (PPE) usage

Personal protective equipment (PPE) is equipment worn to reduce exposure to hazards that cause serious workplace injuries and illnesses. Chemical, radiological, physical, electrical, mechanical, or other workplace hazards may cause these injuries and illnesses. Gloves, safety glasses, and shoes, earplugs or muffs, hard hats, respirators, or coveralls, vests, and full body suits are examples of […]

Product Dossier Registration Process

March 16, 2023 March 16, 2023 pharmabeginers Audit, cGMP, Doc, Micro Sop, QA Sop, Quality Control, SOPs Common Technical Document, Comparative Dissolution Profile, Drug Product Registration, product filing, Technology Transfer DocumentLeave a Comment on Product Dossier Registration Process

Product Dossier (CTD): Dossier is a collection of documents on the particular subjects. Any preparation of pharmaceutical product for human use go through the process of reviewing and assessing the dossier of pharmaceutical product which contains details information about administrative, quality, non- clinical and clinical data. This process is governed and permitted by Drug Regulatory […]

Emergency Plan On Site – Safety SOP

February 21, 2023 February 21, 2023 pharmabeginers cGMP, Checklist, Environment, Health & Safety (EHS), Maintenance Sops, SOPs Chemical spill, flammable or hazardous chemical, Hazard Potential Area, Major fire or explosion, Mock Drills Frequency, natural calamities, Release of toxic, Spillage of Toxic SubstanceLeave a Comment on Emergency Plan On Site – Safety SOP

Standard Operating Procedure for On-site Emergency Plan : The main purpose of the on Site Emergency Plan is for effective mobilization of resources in order to: save lives, rescue victim, minimize injury, timely treatment to the injured personnel, Identify the dead / casualty and minimize the extent of the damage to the resources, inform relatives […]

Good Clinical Practices (GCP) Guideline

January 31, 2023 January 31, 2023 pharmabeginers cGMP, Doc, QA Sop, SOPs Good Clinical Practices, Serious Breach of GCPLeave a Comment on Good Clinical Practices (GCP) Guideline

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. This guideline provides the procedure for Handling and Reporting of serious breaches of Good clinical practices (GCP). GOOD CLINICAL PRACTICES (GCP) – HANDLING AND REPORTING OF SERIOUS BREACHES 1.0   OBJECTIVE […]

« Previous 1 2 3 4 5 6 … 23 Next »

Data Integrity: A Crucial Aspect of Pharmaceutical Quality

December 18, 2023 December 18, 2023 pharmabeginers Blog, cGMP, Doc 211.68(b), audit trail, cGMP quality system, cGMP record, computer or related systems, Data Life cycle, electronic signatures, metadata, reprocessed laboratory chromatography, static and dynamic records, system suitabilityLeave a Comment on Data Integrity: A Crucial Aspect of Pharmaceutical Quality

Data integrity is a fundamental pillar in the field of pharmaceuticals, playing a crucial role in maintaining the quality and safety of medicinal products. In an industry where human lives are at stake, the accuracy and reliability of data are of utmost importance. Therefore, it is imperative for pharmaceutical companies to establish robust systems and […]

Contract Manufacturing (CMO) Management

December 16, 2023 December 16, 2023 pharmabeginers Audit, cGMP, Checklist, QA Sop, SOPs CMO, Common Technical Document, contract agreement, For Cause AuditLeave a Comment on Contract Manufacturing (CMO) Management

Pharmaceutical contract manufacturing refers to the practice of contracting out the production of pharmaceuticals, such as pills, tablets, and capsules, for a third party to consume. Contract Manufacturing (CMO) Management Purpose The purpose of this standard operating procedure is to describe the procedure for Management of Contract Manufacturing service provided by contract Manufacturing Company, which […]

Reagent Solution Preparation Procedure

October 11, 2023 October 11, 2023 pharmabeginers cGMP, GLP, QC Sop, Quality Control, Research Ammonium Acetate Solution, Cobaltous Chloride Colorimetric Reagent, Cupric Sulphate Colorimetric, Ferric Chloride ColorimetricLeave a Comment on Reagent Solution Preparation Procedure

Standard operating procedure (SOP) to prepare the Reagent Solution for chemical analysis in the quality control laboratory General Reagent Solution Preparation 1.0   Objective To lay down the procedure for the preparation of the general reagent solution. 2.0   Scope This SOP is applicable in the Analytical / Quality Control Laboratory for the preparation of reagent solutions 3.0  […]

Quality Manual & Quality Policy in Pharmaceuticals

September 28, 2023 September 28, 2023 pharmabeginers cGMP Leave a Comment on Quality Manual & Quality Policy in Pharmaceuticals

WFIWhat is a Quality Manual (Quality System Manual / QMS Manual? A Quality Manual is a document that was first required by the ISO 9001 standard for Quality Management Systems. A Quality Manual is a top-level document that describes an organization’s Quality Management System (QMS).  It can be used both internally (for employees) and externally […]

Dry Heat Sterilizer (DHS) Validation Protocol

August 10, 2023 August 10, 2023 pharmabeginers cGMP Air Flow Pattern Study, Air velocity measurement, Differential Pressure Monitoring, Endotoxin Challenge Studies, Estimation of  FH Value, Heat Distribution Studies, Integrity Testing of HEPA Filters, Loaded Chamber Heat Penetration Studies, Pre-Qualification Tests, Viable Particle monitoring1 Comment on Dry Heat Sterilizer (DHS) Validation Protocol

oProcedure and protocol for Dry heat sterilizer (DHS) validation, DHS consists of accurately measuring the temp. at critical points within the sterilization chamber throughout the process. Dry heat process generally employs a temperature between 250°C and 400°C for varying time. The sterilizer is required to heat all parts of its load up to the specified […]

Agilent HPLC – Operation & Calibration SOP

July 8, 2023 July 8, 2023 pharmabeginers Calibration, Checklist / Formats, GLP, HPLC, Protocol, QC Sop, Quality Control, SOPs Agilent HPLC Calibration, Agilent HPLC Infinity Series, Agilent HPLC Operation, Auto injector calibration:, Auto Injector Linearity, Cleaning of HPLC, Flow calibration, Gradient Pump Accuracy, HPLC Calibration, Injection Carry Over, Injection volume accuracy:Leave a Comment on Agilent HPLC – Operation & Calibration SOP

uidance is provided on general procedure applicable for operation and calibration of High Performance Liquid Chromatography (HPLC) taking Agilent HPLC Infinity Series (Quaternary Channel) system as an example. Parameters to be considered for calibration of Agilent HPLC. Agilent HPLC – Operation & Calibration Procedure  1.0   Purpose The purpose of this SOP is to describe the […]

MLT Method Validation Procedure & Protocol

June 29, 2023 June 29, 2023 pharmabeginers cGMP, GLP, Micro Sop, Microbiology, Quality Control, SOPs, Validation Inoculum Preparation, Preparation of negative control, Preparation of Positive control, Preparation of test sample, Test for Specified Micro-OrganismsLeave a Comment on MLT Method Validation Procedure & Protocol

The MLT method must be validated before it will be applied when testing a product for resistance to bacteria in order to ensure that the product has no microbial inhibitory characteristics that could lead to false negative results. The MLT Method Suitability Test is known as the title of this validation test. Validation Protocol for MLT […]

Antimicrobial Efficacy Test – Guideline

June 20, 2023 June 20, 2023 pharmabeginers cGMP, Micro Sop, Microbiology, Protocol, QC Sop, Quality Control, SOPs Efficacy Test, Preservative Effectiveness test, stock culture suspensionsLeave a Comment on Antimicrobial Efficacy Test – Guideline

The Antimicrobial Efficacy Test, also known as the preservative effectiveness test, is a compendial test performed during formulation development and stability testing of a parenteral drug product intended as a multi-dose product. Procedure for Antimicrobial Efficacy Test 1.0   Purpose: The purpose of this SOP is to check the efficacy of antimicrobial efficacy Test.  2.0   Scope: […]

Personal Protective Equipment (PPE) usage

March 20, 2023 March 20, 2023 pharmabeginers cGMP, Checklist, Environment, GLP, Health & Safety (EHS), Micro Sop, Microbiology, Production, SOPs Face protection, Foot protection, Hand protection, Head protection, PPEs, Protection against fall, protection against noise, Respiratory protection, Skin & body protectionLeave a Comment on Personal Protective Equipment (PPE) usage

Personal protective equipment (PPE) is equipment worn to reduce exposure to hazards that cause serious workplace injuries and illnesses. Chemical, radiological, physical, electrical, mechanical, or other workplace hazards may cause these injuries and illnesses. Gloves, safety glasses, and shoes, earplugs or muffs, hard hats, respirators, or coveralls, vests, and full body suits are examples of […]

Product Dossier Registration Process

March 16, 2023 March 16, 2023 pharmabeginers Audit, cGMP, Doc, Micro Sop, QA Sop, Quality Control, SOPs Common Technical Document, Comparative Dissolution Profile, Drug Product Registration, product filing, Technology Transfer DocumentLeave a Comment on Product Dossier Registration Process

Product Dossier (CTD): Dossier is a collection of documents on the particular subjects. Any preparation of pharmaceutical product for human use go through the process of reviewing and assessing the dossier of pharmaceutical product which contains details information about administrative, quality, non- clinical and clinical data. This process is governed and permitted by Drug Regulatory […]

Emergency Plan On Site – Safety SOP

February 21, 2023 February 21, 2023 pharmabeginers cGMP, Checklist, Environment, Health & Safety (EHS), Maintenance Sops, SOPs Chemical spill, flammable or hazardous chemical, Hazard Potential Area, Major fire or explosion, Mock Drills Frequency, natural calamities, Release of toxic, Spillage of Toxic SubstanceLeave a Comment on Emergency Plan On Site – Safety SOP

Standard Operating Procedure for On-site Emergency Plan : The main purpose of the on Site Emergency Plan is for effective mobilization of resources in order to: save lives, rescue victim, minimize injury, timely treatment to the injured personnel, Identify the dead / casualty and minimize the extent of the damage to the resources, inform relatives […]

Good Clinical Practices (GCP) Guideline

January 31, 2023 January 31, 2023 pharmabeginers cGMP, Doc, QA Sop, SOPs Good Clinical Practices, Serious Breach of GCPLeave a Comment on Good Clinical Practices (GCP) Guideline

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. This guideline provides the procedure for Handling and Reporting of serious breaches of Good clinical practices (GCP). GOOD CLINICAL PRACTICES (GCP) – HANDLING AND REPORTING OF SERIOUS BREACHES 1.0   OBJECTIVE […]

« Previous 1 2 3 4 5 6 … 23 Next »

About the author

Ms. Janki Singh is professional pharmaceuticals blogger, Founder and Author of Pharma Beginners. She has rich experience in pharmaceutical field. Email: [email protected]

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