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Breakdown Maintenance Procedure and System SOP

cGMP, Maintenance Sops, Micro Sop, Microbiology, Production, Production Sop, SOPs Control of Breakdown Maintenance, Like to Like Replacement, Repetitive Equipment/Machine BreakdownsLeave a Comment

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

cGMP, GLP, Production, Production Sop, QA Sop, QC Sop, Quality Control, SOPs, Validation Event Batches, Extensive sampling, process validation Stratified, Readily pass, Standard criteria method, Stratified in-process dosageLeave a Comment

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

cGMP, Micro Sop, Microbiology, SOPs cell density enumeration, confirmation of count per ml, Enumeration of culture suspension, Fungal culture suspension, Incubation conditions USP, serial dilutions of the bacterial cultures, stock culture suspensionsLeave a Comment

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

cGMP, Checklist, Maintenance Sops, Production, SOPs Cleaning procedure of Punches and dies, Handling and storage of Punches and Dies, Inspection of Punches and Dies, Periodic inspection of Punches and Dies, Procedure for rejection Punches and DiesLeave a Comment

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

cGMP, GLP, Micro Sop, Microbiology, QC Sop, Quality Control, SOPs, Sterile Disposal of used Microbiological Media:, GPT of Microbiological Media, Media reconciliation, Preincubation of Media, Storage of Microbiological Media, Usage of Microbiological MediaLeave a Comment

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

cGMP, Environment, GLP, Health & Safety (EHS), Micro Sop, Microbiology, Production, Production Sop, Protocol, QA Sop, QC Sop, Quality Control, Research, SOPs, Sterile, Validation Clinical Trial, imp clinical trial, impd clinical trial, impd pharmaLeave a Comment

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

cGMP, GC, GLP, HPLC, Protocol, QA Sop, Quality Control, SOPs Column Efficiency Check, Column qualification, Column Regeneration Protocol, Discarding of the HPLC/UPLC Column, handling of HPLC Column, HPLC/UPLC Column1 Comment

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

Audit, Calibration, cGMP, Doc, GLP, Micro Sop, QA Sop, QC Sop, Quality Control, SOPs Analytical QA, GLP, Lab QA, QA of QC, QA Reviewer, QA/QCLeave a Comment

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 […]

Documentum Software – Guideline for Operation

cGMP, Doc, GLP, Maintenance Sops, QA Sop, Quality Control, SOPs Data Management System, DMS, Document and Data, Document Archival, Documentum SystemLeave a Comment

Standard Operating Procedure (SOP) and Guideline for Operation of Documentum software for issuance, approval, rejections, and retrieval of forms and formats. Procedure for Operation of Documentum Software 1.0 Purpose: To define the procedure for the operation of Documentum software. 2.0 Scope: This guideline is applicable to Documentum software for issuance, approval, rejections, and retrieval of […]

Micropipette Calibration and Operation Procedure

Calibration, GLP, Micro Sop, Microbiology, QA Sop, QC Sop, Quality Control, SOPs Micropipette calibration Procedure, Micropipette SOPLeave a Comment

Standard Operating Procedure (SOP) and Protocol for Operation and Calibration of Micropipette (fixed volume or variable volume micropipettes). Operation and Calibration Procedure of Micropipette 1.0 Purpose: To lay down the procedure for Operation and calibration of the Micropipette. 2.0 Scope: This Standard Operating Procedure is applicable at microbiology section of Quality Control department for operation […]

Particle Size Analyzer (Malvern) Operation Calibration

Audit, Calibration, cGMP, GLP, QA Sop, QC Sop, Quality Control, SOPs Malvern Calibration, Mastersizer 2000, Mastersizer 3000, Operation of Malvern, Particle Size Analyzer Calibration, Particle Size Determination, PSD CalibrationLeave a Comment

Standard Operating Procedure (SOP) for Operation, Calibration, and Maintenance of Malvern Make Particle Size Analyzer (Mastersizer 2000 & 3000). SOP for Particle Size Analyzer (Malvern) 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the Operation, Calibration, Maintenance of the Particle Size Analyzer (Malvern). 2.0 SCOPE: This SOP is applicable to […]

Field Alert Report (FAR) – Guidance for Submission

cGMP, Doc, GLP, QA Sop, QC Sop, Quality Control, Research, SOPs File FAR, Form 3331A, Investigation - Field Alert Report, NDA FDA Form 3331, Submission of FARLeave a Comment

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

Environment, GLP, Health & Safety (EHS), Micro Sop, Microbiology, Quality Control, SOPs, Sterile GPT Agar Media, GPT for Liquid Media, GPT of Solid Media, GPT SOP, Growth Promotion qualities, Inhibition Test of Media, Procedure for Growth Promotion TestLeave a Comment

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

cGMP, Checklist, Doc, Production, Production Sop, QA Sop, QC Sop, SOPs, Stores Sops Handling of Goods, Returned Drug Product, Returned MaterialLeave a Comment

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

Calibration, cGMP, GLP, Maintenance Sops, Protocol, Quality Control, Research, SOPs Analytical Balance Calibration, Micro Balance, Semi Micro Balance, Ultra Micro BalanceLeave a Comment

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 […]

Steam Sterilizer – Qualification & Validation Procedure

December 19, 2020 December 15, 2020 pharmabeginers 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

December 16, 2020 December 12, 2020 pharmabeginers 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

December 12, 2020 December 8, 2020 pharmabeginers 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

December 9, 2020 December 2, 2020 pharmabeginers 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

December 5, 2020 November 30, 2020 pharmabeginers 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

December 2, 2020 November 25, 2020 pharmabeginers 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

November 28, 2020 November 20, 2020 pharmabeginers 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

November 25, 2020 November 17, 2020 pharmabeginers 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

November 21, 2020 August 6, 2021 pharmabeginers 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 […]