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Reprocess Rework of API and Drug Product

cGMP, Checklist, Doc, Micro Sop, Microbiology, Production, Production Sop, QA Sop, QC Sop, Quality Control, SOPs, Stores Sops Redressing, Repacking, Reprocessing, Reworking1 Comment on Reprocess Rework of API and Drug Product

Guidance (SOP) about the procedure and documentation of reprocess and rework during Active Pharmaceutical Ingredient (API), excipients, and Drug Product in Pharmaceuticals. Guideline for Reprocess / Rework of API & Drug Product 1.0   Purpose : The purpose of this guideline is to describe the specific requirements for reprocessing and reworking of active pharmaceutical ingredients (API) […]

21 CFR Part 11 : Electronic Records & Signatures

Audit, cGMP, IT SOP, QA Sop, QC Sop, SOPs Closed System, Electronic Record, Electronic Signature, Open SystemLeave a Comment on 21 CFR Part 11 : Electronic Records & Signatures

Guideline (SOP) for Electronic Records & Signatures (21 cfr part 11) and implementation of the same during Data generation and assurance at pharmaceutical drug manufacturing plant and API. 21 CFR Part 11 – Electronic Records & Signatures 1.0   Purpose :  The objective of this Guideline is to define the security controls for Computerized Systems that […]

Media Fill Test – Aseptic Process Simulation in Micro

cGMP, Maintenance Sops, Micro Sop, Microbiology, Production, Production Sop, QA Sop, SOPs, Sterile, Validation Aseptic Practices, Aseptic Process SimulationLeave a Comment on Media Fill Test – Aseptic Process Simulation in Micro

Guideline (SOP) to provide guidance for activities and analyses performed by Microbiology and Environmental Monitoring personnel in support of Aseptic Process Simulations (APS), also referred to as Media Fill Test. Guideline for Aseptic Process Simulation (Media Fill Test) 1.0   Purpose The purpose of this SOP is to provide guidance for activities and analyses performed by […]

Regulatory Audit : Preparation & Handling

Audit, cGMP, Checklist, Checklist / Formats, Doc, GLP, Health & Safety (EHS), IT SOP, Maintenance Sops, Micro Sop, Microbiology, Production, Production Sop, QA Sop, QC Sop, Quality Control, SOPs, Stores Sops Audit Observation, Observation Compliance, Plant Audit, QC AuditLeave a Comment on Regulatory Audit : Preparation & Handling

Standard Operating Procedure (SOP) / Guideline for Preparation and Handling of Regulatory Audit (FDA Inspection) in Pharmaceutical Drug Manufacturing Plant. Handling of Regulatory Audit (FDA Inspection) 1.0   PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Handling the Regulatory Audit. 2.0   SCOPE This SOP shall be used as such […]

Local Area Network (LAN) Qualification Guideline

Audit, cGMP, Checklist / Formats, IT SOP, Maintenance Sops, QA Sop, QC Sop, SOPs, Validation data integrity, IT Policy, LAN DQ, LAN IQ, LAN OQ, LAN PQ, LAN QualificationLeave a Comment on Local Area Network (LAN) Qualification Guideline

Standard Operating Procedure (SOP) for Local Area Network (IT Network / LAN) qualification procedure, Protocol, and related documentation. Procedure for qualification of IT network equipment’s for the fulfillment of availability of hardware as per requirement, guidance for re-qualification and to provide the procedure for numbering of network equipment. Qualification of Local Area Network (LAN) 1.0  […]

Out of Specification Result in Microbiology – Guideline

cGMP, Micro Sop, Microbiology, SOPs Micro OOS, Microbiology OOS, Test Result1 Comment on Out of Specification Result in Microbiology – Guideline

Standard Operating Procedure (SOP) for Handling of Out of Specification (OOS) Test Result in Microbiological Analysis. OOS results include all test results that fall outside of the specification or acceptance criteria established in drug applications, drug master files, official compendia, or by the manufacturer. Handling of (Microbiology) Out-of-Specification (OOS) Results 1.0   Purpose The objective of […]

Validation Master Plan (VMP) Preparation Guideline

cGMP, Maintenance Sops, Micro Sop, Microbiology, Production, Production Sop, QA Sop, SOPs, Validation AMV, PV, VMP-CV2 Comments on Validation Master Plan (VMP) Preparation Guideline

Standard Operating Procedure & Guideline for preparation and control of Validation Master Plan (VMP) for Instrument, Equipment, Facility in the pharmaceutical drug manufacturing plant. SOP for Validation Master Plan (VMP) 1.0   PURPOSE The purpose of this SOP is to lay down the procedure of preparation and control of the Validation Master Plan (VMP). 2.0   SCOPE […]

Technical Agreement – Preparation & Handling

Audit, cGMP, Health & Safety (EHS), Maintenance Sops, Micro Sop, Microbiology, Production, Production Sop, QA Sop, QC Sop, SOPs, Stores Sops Agreement, Contract Lab, Contract PermissionLeave a Comment on Technical Agreement – Preparation & Handling

Standard Operating Procedure for preparation and handling of different types of Technical Agreement. Agreement undertook by written and legally binding on two parties (Contract giver and contract acceptor). Technical Agreement 1.0   PURPOSE: The purpose of this SOP (Standard Operating Procedure) is to describe the procedure for the preparation and handling of all technical agreement (s). […]

Infrastructure Qualification Procedure – Quality IT

Audit, Calibration, cGMP, GLP, QA Sop, QC Sop, Quality Control, SOPs, Validation Computer system validationLeave a Comment on Infrastructure Qualification Procedure – Quality IT

Standard Operating Procedure (SOP) for IT Infrastructure Qualification of Computer System used in cGxP environment at the pharmaceutical company. Computer System – IT Infrastructure Qualification 1.0   Objective  This Procedure defines the procedure for qualifying and maintaining the qualified status (Qualification) of Computerized Systems (CS) Infrastructure to ensure that Computerized Systems that use that infrastructure and […]

Placebo Medicine Batch – Procedure for Handling

cGMP, GLP, Production, Production Sop, QC Sop, Quality Control, SOPs Placebo ProductLeave a Comment on Placebo Medicine Batch – Procedure for Handling

A placebo batch of a product is processed as per regular formulation of that product except for the active ingredient or A dosage form that is identical to the drug product except that the drug substance is absent or replaced by an inert ingredient or a mixture of the drug product excipients quantitatively equivalent to […]

Audit Checklist – Department wise in Pharmaceuticals

cGMP, Checklist, Checklist / Formats, Environment, Health & Safety (EHS), Micro Sop, Microbiology, Production, Production Sop, QA Sop, QC Sop, Quality Control, SOPs, Stores Sops Inspection ChecklistLeave a Comment on Audit Checklist – Department wise in Pharmaceuticals

Audit Checklist (s) for different department/section/area like – Engineering / maintenance, HVAC Area, Purified water system, Quality Control, Warehouse, Granulation, Compression, Coating, Packing / Packaging, Personal and administration (HR), Microbiology and Quality Assurance area etc. to check the effectiveness  of the implemented systems. Checklist for Routine Inspection /Audit 1.0   Audit checklist for Engineering area Sr. […]

Rejection Handling Procedure (API/Drug Product)

cGMP, Production, Production Sop, QA Sop, QC Sop, Quality Control, SOPs Rejected APILeave a Comment on Rejection Handling Procedure (API/Drug Product)

Standard Operating Procedure (SOP) for Handling of Interim/On-line Rejection during manufacturing and packing of drug substances or drug product. Handling of Interim/On-line Rejection 1.0   Purpose : To define procedure for Handling of Interim/On-line Rejections during manufacturing and packing of drug substances. 2.0   Scope : This SOP is applicable for Handling of Interim/On-line Rejections during manufacturing […]

Gram’s Staining Procedure of Microorganisms

cGMP, Environment, GLP, Health & Safety (EHS), Micro Sop, Microbiology, QC Sop, Quality Control, SOPs, Sterile Lacto Phenol Staining, Spore StainingLeave a Comment on Gram’s Staining Procedure of Microorganisms

Standard Operating Procedure (SOP) for Gram’s Staining of Microorganisms. Gram stain or Gram staining, also called Gram’s method, is a method of staining used to distinguish and classify bacterial species into two large groups: gram-positive bacteria and gram-negative bacteria. The name comes from the Danish bacteriologist Hans Christian Gram, who developed the technique Procedure for […]

Incident Handling and Investigation Procedure – EHS

cGMP, Environment, Health & Safety (EHS), Production, QA Sop, QC Sop, SOPs, Stores Sops Accident, Dangerous Occurrences, Environmental Incidents, Fatal Incident, Fire Incidents, First Aid Incident, Incident, Near Miss, Occupational IllnessLeave a Comment on Incident Handling and Investigation Procedure – EHS

Standard Operating Procedure (SOP) for Handling, Investigation, Classification and Reporting of Incident by Environmental,  Health and Safety (EHS) department in pharmaceuticals. Incident Investigation, Classification and Reporting (EHS) 1.0   PURPOSE: To laydown a procedure to describe the incident, its classification, the requirement of investigation and its reporting procedure by Environment, Health and Safety Department (EHS). The […]

Programmable Logic Controller (PLC) Qualification

Calibration, cGMP, Checklist, Maintenance Sops, Production, Production Sop, Protocol, QA Sop, Validation HDMI, PLC Calibration, PLC Validation1 Comment on Programmable Logic Controller (PLC) Qualification

Protocol and Procedure for Installation Qualification of Programmable Logic Controller (PLC) connected with Manufacturing Equipment. Installation Qualification of Programmable Logic Controller (PLC) 1.0   Objective : The objective of this protocol to provide the written guidelines for execution of the installation qualification of Programmable Logic Controller (PLC) based HMI System for ________ Define the installation qualification […]

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Microbiologist Qualification : SOP & Protocol

January 3, 2023 January 3, 2024 pharmabeginers 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)

July 7, 2022 July 7, 2022 pharmabeginers 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)

March 25, 2022 March 25, 2022 pharmabeginers 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

February 12, 2022 March 6, 2025 pharmabeginers 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

November 16, 2021 November 16, 2021 pharmabeginers 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

November 11, 2021 November 11, 2021 pharmabeginers 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

October 30, 2021 October 30, 2021 pharmabeginers 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

October 28, 2021 October 28, 2021 pharmabeginers 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

October 19, 2021 October 19, 2021 pharmabeginers 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: […]

Reprocess Rework of API and Drug Product

October 14, 2021 October 14, 2021 pharmabeginers cGMP, Checklist, Doc, Micro Sop, Microbiology, Production, Production Sop, QA Sop, QC Sop, Quality Control, SOPs, Stores Sops Redressing, Repacking, Reprocessing, Reworking1 Comment on Reprocess Rework of API and Drug Product

Guidance (SOP) about the procedure and documentation of reprocess and rework during Active Pharmaceutical Ingredient (API), excipients, and Drug Product in Pharmaceuticals. Guideline for Reprocess / Rework of API & Drug Product 1.0   Purpose : The purpose of this guideline is to describe the specific requirements for reprocessing and reworking of active pharmaceutical ingredients (API) […]

21 CFR Part 11 : Electronic Records & Signatures

September 13, 2021 September 13, 2021 pharmabeginers Audit, cGMP, IT SOP, QA Sop, QC Sop, SOPs Closed System, Electronic Record, Electronic Signature, Open SystemLeave a Comment on 21 CFR Part 11 : Electronic Records & Signatures

Guideline (SOP) for Electronic Records & Signatures (21 cfr part 11) and implementation of the same during Data generation and assurance at pharmaceutical drug manufacturing plant and API. 21 CFR Part 11 – Electronic Records & Signatures 1.0   Purpose :  The objective of this Guideline is to define the security controls for Computerized Systems that […]

Media Fill Test – Aseptic Process Simulation in Micro

September 8, 2021 September 8, 2021 pharmabeginers cGMP, Maintenance Sops, Micro Sop, Microbiology, Production, Production Sop, QA Sop, SOPs, Sterile, Validation Aseptic Practices, Aseptic Process SimulationLeave a Comment on Media Fill Test – Aseptic Process Simulation in Micro

Guideline (SOP) to provide guidance for activities and analyses performed by Microbiology and Environmental Monitoring personnel in support of Aseptic Process Simulations (APS), also referred to as Media Fill Test. Guideline for Aseptic Process Simulation (Media Fill Test) 1.0   Purpose The purpose of this SOP is to provide guidance for activities and analyses performed by […]

« Previous 1 2 3 4 5 6 7 … 23 Next »

Microbiologist Qualification : SOP & Protocol

January 3, 2023 January 3, 2024 pharmabeginers 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)

July 7, 2022 July 7, 2022 pharmabeginers 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)

March 25, 2022 March 25, 2022 pharmabeginers 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

February 12, 2022 March 6, 2025 pharmabeginers 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

November 16, 2021 November 16, 2021 pharmabeginers 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

November 11, 2021 November 11, 2021 pharmabeginers 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

October 30, 2021 October 30, 2021 pharmabeginers 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

October 28, 2021 October 28, 2021 pharmabeginers 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

October 19, 2021 October 19, 2021 pharmabeginers 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: […]

Reprocess Rework of API and Drug Product

October 14, 2021 October 14, 2021 pharmabeginers cGMP, Checklist, Doc, Micro Sop, Microbiology, Production, Production Sop, QA Sop, QC Sop, Quality Control, SOPs, Stores Sops Redressing, Repacking, Reprocessing, Reworking1 Comment on Reprocess Rework of API and Drug Product

Guidance (SOP) about the procedure and documentation of reprocess and rework during Active Pharmaceutical Ingredient (API), excipients, and Drug Product in Pharmaceuticals. Guideline for Reprocess / Rework of API & Drug Product 1.0   Purpose : The purpose of this guideline is to describe the specific requirements for reprocessing and reworking of active pharmaceutical ingredients (API) […]

21 CFR Part 11 : Electronic Records & Signatures

September 13, 2021 September 13, 2021 pharmabeginers Audit, cGMP, IT SOP, QA Sop, QC Sop, SOPs Closed System, Electronic Record, Electronic Signature, Open SystemLeave a Comment on 21 CFR Part 11 : Electronic Records & Signatures

Guideline (SOP) for Electronic Records & Signatures (21 cfr part 11) and implementation of the same during Data generation and assurance at pharmaceutical drug manufacturing plant and API. 21 CFR Part 11 – Electronic Records & Signatures 1.0   Purpose :  The objective of this Guideline is to define the security controls for Computerized Systems that […]

Media Fill Test – Aseptic Process Simulation in Micro

September 8, 2021 September 8, 2021 pharmabeginers cGMP, Maintenance Sops, Micro Sop, Microbiology, Production, Production Sop, QA Sop, SOPs, Sterile, Validation Aseptic Practices, Aseptic Process SimulationLeave a Comment on Media Fill Test – Aseptic Process Simulation in Micro

Guideline (SOP) to provide guidance for activities and analyses performed by Microbiology and Environmental Monitoring personnel in support of Aseptic Process Simulations (APS), also referred to as Media Fill Test. Guideline for Aseptic Process Simulation (Media Fill Test) 1.0   Purpose The purpose of this SOP is to provide guidance for activities and analyses performed by […]

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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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