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Bursting Strength Tester – Operation & Calibration

Calibration, cGMP, GLP, Maintenance Sops, QC Sop, Quality Control, SOPs Foil Bursting Test, Packing Material Testing, Shipper TestingLeave a Comment

Standard Operating Procedure (SOP) for operation, calibration, and maintenance of Bursting Strength Tester used to analyze the packing material of drug products. SOP for Bursting Strength Tester 1.0 PURPOSE: The purpose of this SOP is to describe the operation, calibration, and maintenance of the Bursting strength tester. 2.0 SCOPE: This SOP is applicable to the […]

Leak Test Apparatus – Operation and Cleaning SOP

cGMP, Production, Production Sop, QA Sop, SOPs Blister Seal Test, Leak Test, Sealing test of tablet capsule, Strip Leak TestLeave a Comment

Standard Operating System (SOP) for Operating, cleaning of Leak Test Apparatus which is used to check the leak seal test of packed strips, blisters, sachets, and bottle packs. Procedure For Leak Test (Leak Test Apparatus) 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the detailed procedure for checking the Leak […]

Blister Packing Machine (BQS) -Cleaning & Operation

cGMP, Checklist, Checklist / Formats, Production, Production Sop, SOPs Cleaning Blister Packing Machine, Cleaning of BQS, Drug Product Packing, Operation of BQS, SOP for Blister PackingLeave a Comment

Standard Operating Procedure for Cleaning and Operation of Blister Packing Machine (BQS) used for the packing of the pharmaceutical drug products. SOP for Blister Packing Machine (BQS) 1.0 PURPOSE: The purpose of this SOP is to lay down the procedure for the cleaning and operation of the Blister Packing Machine (BQS). 2.0 SCOPE – SOP […]

Rubber Stereos : SOP for Procurement, Handling & Destruction

cGMP, Checklist, Production, Production Sop, QA Sop, SOPs Batch Details Printing, Blister Printing, StereoLeave a Comment

Standard Operating Procedure (SOP) for the identification of requirement, procurement, handling, issuance, and destruction of Rubber Stereos used for batch details overprinting of various products. SOP FOR RUBBER STEREOS 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to lay down the procedure for identity, procuring, handling, issuance, and destruction of rubber stereos […]

Stability Study Samples Withdrawal & Analysis SOP

cGMP, Doc, GLP, QA Sop, QC Sop, Quality Control, SOPs Stability Sample Analysis, Stability Sample withdrawalLeave a Comment

Standard Operating Procedure (SOP) for withdrawal and analysis of Stability Study Samples (Finished Drug Product) from stability chambers. Withdrawal and Analysis of Stability Study Samples 1.0 PURPOSE: The purpose of this SOP is to define the procedure for Withdrawal and Analysis of Stability Study samples from the stability chamber. 2.0 SCOPE: This SOP is applicable […]

Procedure for Fumigation of Production Area

cGMP, Environment, Health & Safety (EHS), Micro Sop, Microbiology, Production, Production Sop, SOPs, Sterile Area Monitoring, Fumigation of Area, Fumigation of MicrobiologyLeave a Comment

Standard Operating Procedure (SOP) for Fumigation of the Production area by using Virosil at pharmaceutical drug manufacturing plants. Fumigation in Production Area 1.0 PURPOSE: To lay down a procedure for the fumigation of the production area. 2.0 SCOPE: This standard operating procedure is applicable to the production area in pharmaceutical drug manufacturing plants. 3.0 RESPONSIBILITY […]

Metal Detector – SOP for Cleaning and Operation

cGMP, Production, Production Sop, SOPs Metal Detector, Tablet Capsule Deduster, Tablet inspection1 Comment

Standard Operating Procedure (SOP) for Operation and Cleaning of Metal Detector and Combo Metal Detector cum Deduster used during the manufacturing of drug products in pharmaceuticals. SOP for Metal Detector / Deduster 1.0 PURPOSE: The purpose of this SOP is to describe the cleaning and operation of metal detector and digital combo metal detector cum […]

Mechanical Stirrer – SOP for Cleaning and Operation

cGMP, Production, Production Sop, QA Sop, SOPs Production Equipment, Tablet Granulation EquipmentLeave a Comment

Standard Operating Procedure (SOP) for cleaning and operation of Mechanical Stirrer used in granulation at drug product manufacturing in pharmaceuticals. SOP for Cleaning and Operation of Mechanical Stirrer 1.0 PURPOSE: The purpose of this SOP is to lay down the cleaning and operation procedure for Mechanical Stirrer. 2.0 SCOPE: This SOP is applicable for the […]

Batch Processing – SOP & General Check Points

cGMP, Checklist, Checklist / Formats, Production, Production Sop, QA Sop, SOPs Capsule Batch Manufacturing, Drug Manufacturing Checklist, Drug Processing, Tablet ManufacturingLeave a Comment

.perating Procedure (SOP) for General Check Point during Drug Product Batch Processing in the pharmaceuticals drug manufacturing plant. General Checks and Precautions During Processing of Batch 1.0 PURPOSE: The purpose of this SOP is to lay down the procedure for General Checks & Precautions during Processing of Batch. 2.0 SCOPE: This SOP is applicable for […]

Non-Recoverable Recovery – Handling & Destruction

cGMP, Production, Production Sop, SOPs non-recoverable recovery, Rocovery cunsumptionLeave a Comment

Standard Operating Procedure (SOP) for handling and destruction of Non-Recoverable Recovery generated during the processing of pharmaceutical drug products. Handling and Destruction of non-recoverable Recovery 1.0 PURPOSE: The purpose of this SOP to lay down the procedure for handling and destruction of non-recoverable Recovery. 2.0 SCOPE: This SOP is applicable for followings, Handling and destruction […]

Stability Study Protocol and Specification – SOP

Calibration, cGMP, Checklist / Formats, Protocol, SOPs Protocol Format, Stability Analysis Protocol, Stability ProtocolLeave a Comment

Standard Operating Procedure (SOP) for preparation, Issuance, and Execution of Stability Study Protocol, Analytical Template, and Specification of Drug Product. Stability Study Protocol, Template & Specification Preparation 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for the preparation of the stability study protocol/template/Specification in the Quality Control department. […]

Muffle Furnace – Operation and Calibration SOP

Calibration, cGMP, GLP, QC Sop, Quality Control, SOPs Loss on Ignition, Residue on Ignition, Sulphated Ash TestingLeave a Comment

Standard Operating Procedure (SOP) for Operation and Calibration check of muffle furnace installed in quality control lab for analysis of sulfated ash, loss on ignition (LOI), etc. SOP for Muffle Furnace 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for Operation and Performance Check procedure of Muffle Furnace and general practices […]

Vacuum Oven – Operation and Calibration SOP

Calibration, cGMP, GLP, QC Sop, Quality Control, SOPs Calibration of Vacuum Oven, Validation of Vacuum OvenLeave a Comment

Standard Operating Procedure (SOP) for Operation and Calibration of vacuum oven used in quality control laboratory and R&D in pharmaceuticals. SOP for Vacuum Oven 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for the Operation and Calibration of Vacuum Oven. 2.0 SCOPE: This SOP is applicable for the […]

Dynamic Pass Box – Operation, Cleaning & Qualification

cGMP Change Room Practices, Micro media movement, Static Pass BoxLeave a Comment

Standard Operating Procedure (SOP) for Operation, Cleaning, and Qualification of Dynamic Pass Box used in the pharmaceutical manufacturing plant. Dynamic Pass Box used for the transfer of material from one area to another in isolation by means of mechanical/electromagnetic door interlocking process that ensures opening of only one door at a time. This process helps […]

Stability Chamber – Operation, Cleaning and Performance check

Calibration, cGMP, Checklist / Formats, GLP, QA Sop, QC Sop, Quality Control, SOPs Emergency alarm of Stability Chamber, Operation of Stability Chamber, Stability Chamber Challenge Test, Stability Oven CalibrationLeave a Comment

Standard Operating procedure (SOP) for Operation, Cleaning, and Performance Check/Calibration of Stability chamber (Oven) used for the stability study of drug products. Handling of Stability Chamber/Oven 1.0 Purpose: The purpose of this SOP is to describe the procedure for qualification and monitoring of the stability chamber/oven. 2.0 Scope: This procedure is applicable to the stability […]

Purified Water Plant – Operation and Regeneration

September 16, 2020 September 11, 2020 pharmabeginers cGMP, Health & Safety (EHS), Maintenance Sops, Micro Sop, QA Sop, QC Sop, SOPs, Validation Acid regeneration of Water System, frequency for the regeneration of Water Plant, Regeneration of Mixed bed, Water System Operation1 Comment

Standard Operating Procedure (SOP) to define the procedure for operation and regeneration of the Purified Water Plant (Mixed bed unit). SOP for Purified Water Plant 1.0 PURPOSE: To define the procedure for operation and regeneration of Purified Water Plant (Mixed bed unit). 2.0 SCOPE: This procedure is applicable to the operation and regeneration of the […]

Auto Titrator – Operation and Calibration SOP

September 15, 2020 September 11, 2020 pharmabeginers Calibration, cGMP, GLP, QC Sop, Quality Control, SOPs Calibration of Auto Titrator, Electrode Calibration, PotentiometerLeave a Comment

Standard Operating Procedure (SO) for Operation and Calibration of Auto Titrator (Potentiometer) for its utility in carrying out different types of Titration SOP for Auto Titrator (Potentiometer) 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for the Operation and Calibration of the Auto Titrator for its utility in […]

Residual Solvent Limit in Raw Material (API) – SOP

September 14, 2020 September 14, 2020 pharmabeginers cGMP, GLP, Health & Safety (EHS), Production, Production Sop, QA Sop, QC Sop, Quality Control, SOPs Class 1 solvents, Residual Solvent BP, Residual Solvent ICH Q3 C, Residual Solvent IP, Residual Solvent USPLeave a Comment

Residual solvent in pharmaceuticals is defined here as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. LIMIT OF RESIDUAL SOLVENTS IN DRUG PRODUCT 1.0 Purpose: The purpose of this Standard Operating Procedure (SOP) is to describe the limit of residual […]

SOP for Protocol and Report Numbering System

September 13, 2020 September 13, 2020 pharmabeginers cGMP, Checklist / Formats, Protocol, QA Sop, SOPs, Validation Protocol Issuance, Protocol Numbering, Protocol SOP, URS No. IssuanceLeave a Comment

Standard Operating System (SOP) issuance, controlling, and management of different Protocols and its numbering System in pharmaceuticals for different activities. A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report, and approval. Protocol Numbering System 1.0 PURPOSE: The purpose of this SOP […]

Specimen Signature Recording SOP of Employee

September 12, 2020 September 12, 2020 pharmabeginers cGMP, Checklist / Formats, GLP, QA Sop, SOPs Full Signature, Initial Signature, Signature for RecordLeave a Comment

Standard Operating Procedure (SOP) for the recording of Specimen Signatures of Employees and contract personnel. Specimen Signature is a copy of your name written by yourself that an organization keeps so that they can be sure that your name on a document was also written by you. SOP for Recording of Specimen Signature 1.0 PURPOSE: […]

Refrigerator – Operation & Performance Check

September 11, 2020 September 11, 2020 pharmabeginers cGMP, Micro Sop, Microbiology, SOPs Culture Storage, Media Storage for MicroLeave a Comment

Standard Operating Procedure (SOP) for Operation, Cleaning, and Performance Check for Refrigerator used to store the Microbiology Culture, Spores, Media, etc in the Microbiology Lab. Refrigerator Used in Microbiology Lab 1.0 Purpose: The purpose of this SOP is to describe the Operation, Cleaning, and Performance check procedure of Refrigerator used for the storage of microbiology […]

New Product Introduction (Risk Evaluation)

September 9, 2020 July 23, 2022 pharmabeginers cGMP, Checklist, Checklist / Formats, Environment, Health & Safety (EHS), Production, Production Sop, QA Sop, QC Sop, SOPs, Validation Cross Contaimination, Drug Product Introduction, New Product LaunchLeave a Comment

This SOP provides guidance to evaluate the potential of the proposed new product for cross-contamination and assessment of the containment approach required to manufacture the new product at Manufacturing and Packaging Facilities. For existing products, Quality Risk Management for Cross-contamination shall be performed as per SOP “Prevention of cross-contamination, Mix up and Microbial Contamination” for […]

UPLC System Calibration Procedure

September 7, 2020 September 7, 2020 pharmabeginers Calibration, cGMP, Checklist / Formats, GLP, HPLC, QC Sop, Quality Control, SOPs UPLC Calibration, UPLC SOP, UPLC System1 Comment

Calibration Procedure / SOP for Ultra Performance Liquid Chromatography (UPLC) System. UPLC can be regarded as a new direction for liquid chromatography. UPLC refers to ultra-performance liquid chromatography, which improves in three areas: “speed, resolution, and sensitivity”. This Procedure is applicable for Waters Make UPLC – Aquity, UPLC – H Class, Thermo Make U-HPLC Systems, […]

LOD Oven – Operation and Maintenance SOP

September 5, 2020 August 19, 2020 pharmabeginers cGMP, GLP, QC Sop, Quality Control, SOPs LOD Oven, Loss on Drying, Vacuum OvenLeave a Comment

Standard Operating Procedure (SOP) for operation and maintenance of the Oven used to determine the Loss on Drying (LOD) in the Quality Control Department. Loss on drying (LOD) is the loss of weight expressed as percentage w/w resulting from water and volatile matter of any kind that can be driven off under specified condition. SOP […]

Flame Photometer – Operation and Calibration SOP

September 2, 2020 August 18, 2020 pharmabeginers cGMP, GLP, QC Sop, Quality Control, SOPs Flame PhotometryLeave a Comment

Standard Operating Procedure (SOP) for Operation, Cleaning, and Calibration of Flame Photometer used in inorganic chemical analysis to determine the concentration of certain metal ions, among them sodium, potassium, lithium, and calcium. SOP for Flame Photometer 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the operation and calibration of the […]

Cross Contamination, Mix-Ups & Microbial Contamination

August 31, 2020 August 31, 2020 pharmabeginers Audit, cGMP, Checklist, Checklist / Formats, Doc, Environment, Health & Safety (EHS), Maintenance Sops, Micro Sop, Microbiology, Production, Production Sop, QA Sop, QC Sop, Quality Control, SOPs, Sterile, Validation Microbial contamination, Mix up, Prevention of contaimination, Risk Assessment for Cross Contamination, Source of Contamination

Standard Operating Procedure (SOP) and Detailed Risk Assessment approach for Prevention of Cross Contamination, Mix-ups, and Microbial Contamination. Prevention of Cross Contamination, Mix-Ups & Microbial Contamination 1.0 PURPOSE: The purpose of this procedure is to ensure that the manufacture of all finished drug products and Active Pharmaceutical Ingredients is accompanied by risk-based approaches and controls […]

Sieve Shaker – Operation and Cleaning SOP

August 29, 2020 August 14, 2020 pharmabeginers cGMP, GLP, QC Sop, Quality Control, SOPs Particle Size DeterminationLeave a Comment

Standard Operating Procedure (SOP) for Operation and Cleaning of Electromagnetic Sieve Shaker which is used to determine the particle size of pharmaceutical starting material (API and Excipients). SOP for Electromagnetic Sieve Shaker 1.0 Purpose: The purpose of this SOP ( Standard Operating Procedure) is to describe the operation of Electromagnetic sieve shaker. 2.0 Scope: This […]

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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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