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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 […]

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 suspensions1 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 Media1 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 pharma3 Comments

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 Column2 Comments

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 […]

Equipment Usage Logbook – Procedure & Format

February 6, 2021 February 4, 2021 pharmabeginers cGMP, GLP, QA Sop, QC Sop, Quality Control, SOPs entry is missed, Erroneous entries, Log book Maintenance, Logbook Issuance Procedure, wrong entry1 Comment

Standard Operating Procedure (SOP) and Format for Instrument, Equipment usage logbook used for day to day activity and recording of usage details in pharmaceuticals. Equipment Usage Logbook 1.0 PURPOSE: This purpose of this SOP is to define the procedure for issuance, handling, making entries and review of “Instrument/ Equipment usage logbook”. 2.0 SCOPE: This procedure […]

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 SURVEYS2 Comments

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) […]

User Requirement Specification (URS) Handling SOP

January 9, 2021 January 4, 2021 pharmabeginers 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

January 7, 2021 January 7, 2021 pharmabeginers 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

January 1, 2021 December 31, 2020 pharmabeginers 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

December 30, 2020 December 29, 2020 pharmabeginers cGMP, Checklist, Checklist / Formats, GLP, QC Sop, Quality Control, SOPs, Stores Sops Primary Packing Material, Sampling of PPM, Secondary Packaging Material1 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

December 26, 2020 December 23, 2020 pharmabeginers 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 […]

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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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