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Polarimeter – Operation, Cleaning, Calibration SOP

Calibration, Checklist / Formats, GLP, QC Sop, Quality Control, SOPs Polarimeter - Sucrose Calibration, Polarimeter Calibration by Quartz Rotatory Plate Q, Polarimeter Calibration SOP, Quartz Rotatory Plate1 Comment

Standard Operating Procedure (SOP) for Operation, Calibration, Cleaning and general maintenance of Jasco make Polarimeter instrument. Procedure for Operation, Calibration, and Cleaning of Polarimeter 1.0 Purpose: The purpose of this SOP is to describe the procedure for operation, cleaning, and calibration of the polarimeter. 2.0 Scope: This SOP is applicable to the polarimeter available in […]

Neocota Coating Machine : Operation/Cleaning SOP

cGMP, Maintenance Sops, Production, Production Sop, SOPs Cleaning of Neocota Coating, Coating Machine SOP, Operation of NeocotaLeave a Comment

Standard Operating Procedure (SOP) for Operation and Cleaning of Neocota Coating Machine 48’’ & 60’’ used in the coating process. SOP for Neocota Coating Machine 1.0 Purpose: The purpose of this SOP is to describe the procedure for efficient cleaning & operation of Neocota 48’’ & 60’’ in the coating process. 2.0 Scope: This SOP […]

Conductivity Meter – SOP for Operation,Calibration

Calibration, Checklist / Formats, GLP, QC Sop, Quality Control, SOPs Calibration of Conductivity Meter, Cleaning of Conductivity Meter, Conductivity Meter SOP, Operation of Conductivity Meter1 Comment

Standard Operating Procedure (SOP) for Operation, Calibration, and Cleaning of the Conductivity meter. Conductivity is the ability of a solution to conduct electricity and the electricity is conducted in solution by ions present unit of measurement of conductivity is Siemen (S). Procedure for Operation and Calibration of Conductivity Meter 1.0 PURPOSE: The purpose of this […]

Handling of Hold Time Drug Samples

cGMP, Production Sop, QA Sop, SOPs, Validation Hold Time of Blend, Hold Time of Coated Tablet2 Comments

Standard Operating Procedure (SOP) to establish the hold time of drug samples at the different stages of manufacturing (like starting material/Raw material, Intermediate and bulk product) prior to the final packing of the drug. Procedure to Establish the Hold Time of Samples Visit to copy this SOP 1.0 PURPOSE: The purpose of this SOP is […]

Compression Machine : Operation and Cleaning SOP

cGMP, Maintenance Sops, Production, Production Sop, SOPs Compression Machine Cleaning, Operation Compression Machine, Tablet Compression MachineLeave a Comment

Standard Operating Procedure (SOP) for Cleaning and Operation Procedure for double rotary Tablet Compression Machine (45 And 55 Station). Operation and Cleaning Procedure of Tablet Compression Machine 1.0 PURPOSE: To lay down the efficient cleaning and operation of Double rotary compression machine Cadpress 45/55 stations Mark IV. 2.0 SCOPE: This procedure is applicable for the […]

SOP for Workplace During COVID-19 (Corona Virus)

cGMP, Health & Safety (EHS) Corona Safety at Workplace, Corona Virus, COVID 19Leave a Comment

Standard Operating Procedure (SOP) of Workplace instructions pertaining to health protocol during COVID-19 (Corona Virus) pandemic to be complied with by the pharmaceutical drug manufacturing plant. Health Protocol at the Workplace (Pharma) during COVID-19 (Corona Virus) 1.0 PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for health safety […]

Sampling and AQL of Packing Material

QC Sop, Quality Control, SOPs, Stores Sops AQL of Packing Material, Packing Material in Pharma1 Comment

Standard Operating Procedure (SOP) for the sampling of packing material (Primary Packing Material, Secondary Packing Material, and Tertiary Packing Material). Military Standard procedure. Procedure for Sampling and AQL of Packing Material 1.0 PURPOSE: The purpose of this SOP is to define the procedure for sampling and acceptance Quality level of packing materials. 2.0 SCOPE: This […]

Cleaning, Handling and Storage of FBD Bags

cGMP, Production, Production Sop, SOPs Destruction of FBD bag, FBD Bag Cleaning Procedure, FBD Bag Re-inspection, FBD Bag Receipt Check ListLeave a Comment

Standard Operating Procedure (SOP) for Cleaning, Handling, and Storage of Fluid Bed Dryer FBD Bags for a different group of the drug product in the pharma plant. Procedure for Cleaning, Handling, and Storage of FBD Bags 1.0 PURPOSE: The purpose of this SOP is to define the cleaning, handling, and storage of FBD bags. 2.0 […]

SOP for Status Label in Production

cGMP, Production, Production Sop, SOPs, Stores Sops Equipment Label, In process Labels, Labeling SOP, Status Labeling, Under Process Quarantine1 Comment

Standard Operating procedure (SOP) for identification and status label/labeling procedure of product, accessories equipment, and various manufacturing areas. Status Label/Labelling Procedure PURPOSE: To lay down the identification and status labeling procedure of Products, Containers, Accessories, Equipment, and Areas. SCOPE: This procedure is applicable to the WIP labels used in Warehouse, Granulation, Compression, Coating, Packing & […]

SOP for Batch Size Determination

cGMP, Production, Production Sop, SOPs Batch Size Calculation, Bulk Granules weight, coating pan size vs batch size1 Comment

Standard Operating Procedure (SOP) for Batch Size Determination according to the chain of production equipment and equipment capacity. Batch Size determination based on the risk assessment. Procedure for Determination of Batch Size 1.0 PURPOSE: This Standard Operating Procedure (SOP) describes in detail the procedure to be followed for the determination of the batch […]

FTIR-Operation and Calibration SOP

Calibration, Checklist / Formats, GLP, Quality Control, SOPs FTIR CALIBRATION SOP, MAINTENANCE OF FTIR, OPERATION OF FTIR

Standard Operating Procedure (SOP) for Operation, Calibration, Cleaning, and Maintenance of FTIR (Fourier Transform Infrared Spectrometer). Procedure for Operation and Calibration of FTIR 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the start-up, operation, calibration, and maintenance procedure of the FTIR – Fourier Transform Infrared Spectrophotometer. Visit to copy this […]

SOP for Training Management in Pharma

cGMP, QA Sop, SOPs Classroom training, Evaluation of External training, External Training:, On Job Training :, Pharma training management, QA training, QC training, Retraining, Training SOP5 Comments

Standard Operating Procedure (SOP) for Training Management of newly joined as well as an existing employee (staff and workers) working in a cGMP environment in pharmaceuticals. Procedure for Training Management 1.0 PURPOSE: The purpose of this SOP is to describe the procedure to provide the guideline for training (TRN) of employees. 2.0 […]

SOP for Handling of Market Complaint

cGMP, Checklist / Formats, Production, Production Sop, Protocol, QA Sop, Research, SOPs Handling of Market Complaint, Investigation of Market Complaint, Marcket Complaint SOP3 Comments

Standard Operating Procedure (SOP) for Handling of Market Complaint of Finished Pharmaceutical Drug Product. A market/consumer complaint is a notification that the product in commercial distribution- May be in violation of the laws or regulations administered by the FDA. May have caused illness, injury or death. Is alleged to have caused problems not covered by […]

Calibration of Total Organic Carbon (TOC) Analyzer

Calibration, Checklist, Micro Sop, Microbiology, QC Sop, SOPs Calibration of Shimadzu TOC, TOC analyzer, TOC calibration sop, TOC system suitability, Total Organic Carbon Analyzer1 Comment

SOP for Operation and Calibration of Total Organic Carbon (TOC) analyzer. This measurement is proportional to the carbon in the sample. Carbon dioxide shows a unique adsorption spectrum when IR energy passes through it. Operation and Calibration of Total Organic Carbon (TOC) Analyzer 1.0 PURPOSE: To lay down the procedure for Operation […]

Water Analysis SOP as per IP/BP/USP

Micro Sop, Microbiology, QC Sop, SOPs, Sterile Limit test of water, Micro test of water, pharmaceutical water testing, Purified Water Testing, water chemical testing, Water Testing

Standard Operating Procedure (SOP) for Water Sample Analysis as per IP/BP/USP. Procedure for chemical testing and microbiological testing of Raw/Tap water, RO water, and purified water samples. Procedure for Water Analysis (Chemical & Microbiological) 1.0 PURPOSE: To lay down a procedure for analysis of water samples (Chemical and Microbiological Analysis) 2.0 […]

HVAC System Qualification Protocol (Validation)

July 29, 2020 July 29, 2020 pharmabeginers cGMP, Maintenance Sops, Micro Sop, Microbiology, Production, Production Sop, Protocol, SOPs, Sterile, Validation HVAC Qualification Protocol1 Comment

Protocol for Qualification and Re-Qualification or Validation of Heating Ventilation and Air Conditioning (HVAC) system for Clean Room. HVAC System Qualification Protocol (Validation) Table of Content – HVAC System Qualification Protocol S.No. Table of Contents Page 1.0 Protocol Approval 2.0 History Sheet 3.0 Objective 4.0 Scope 5.0 Responsibilities 6.0 Equipment Description 6.1 System Specification […]

HVAC System : SOP for Qualification

July 27, 2020 July 29, 2020 pharmabeginers Calibration, cGMP, Checklist / Formats, Maintenance Sops, Micro Sop, Microbiology, Production Sop, SOPs, Validation AIR PRESSURE DIFFERENTIAL TEST, Air velocity measurement, AIRFLOW PATTERN TEST, calculation of Air Changes (ACPH), DECONTAMINATION /RECOVERY STUDY, INTEGRITY TEST OF HEPA FILTER, NON VIABLE AIRBORNE PARTICLE COUNT, TEMPERATURE AND HUMIDITY CONTROL TEST2 Comments

Standard Operating System (SOP) for Qualification and Re-Qualification of Heating Ventilation and Air Conditioning (HVAC) system for Clean Room. Qualification of HVAC System 1.0 PURPOSE The Purpose of this SOP is to lay down the Procedure for qualification/Requalification, of Heating Ventilation and Air Conditioning System (HVAC). 2.0 SCOPE This SOP is applicable for the qualification/requalification […]

Pharmacopoeial Change Management SOP

July 25, 2020 July 20, 2020 pharmabeginers cGMP, Checklist / Formats, Doc, Production, Production Sop, QA Sop, QC Sop, Quality Control, SOPs, Stores Sops New Monograph, Pharmcopoeial Revision, Product Pharmacopoeial Change, Revised Monograph1 Comment

Standard Operating Procedure (SOP) for the handling of Pharmacopoeial Change at Drug Product Manufacturing Location. Handling when Pharmacopoeial changes in monographs and appearance of the new monographs for drug substances, excipients, drug products and updation or addition or deletion of general chapters. Handling of Pharmacopoeial Change at Drug Manufacturing Location 1.0 Purpose: To define the […]

Dissolution Apparatus – Operation & Calibration SOP

July 22, 2020 July 18, 2020 pharmabeginers Calibration, cGMP, Checklist / Formats, GLP, QC Sop, Quality Control, SOPs Disso Apparatus, Disso Calibration SOP, Dissolution Test Apparatus, Tablet DissolutionLeave a Comment

Standard Operating Procedure (SOP) for Operation and Calibration of Dissolution Test Apparatus (Make- Electrolab) used to measure the drug release of Oral Solid Doses in pharmaceuticals. This SOP Contains following Topics – A) Operating Procedure for Electrolab Dissolution Apparatus, Model : TDT-08L 0, TDT-14L, and similar models. B) Calibration Procedure and Formats for Dissolution Apparatus […]

Melting Point Apparatus – SOP

July 20, 2020 July 4, 2020 pharmabeginers Calibration, cGMP, GLP, QC Sop, Quality Control, SOPs Identification by Melting point, Melting Point CalibrationLeave a Comment

Standard Operating Procedure (SOP) for Operation and Calibration of Melting Point Apparatus used for analysis / identification of starting materials (Raw Material – API & Excipient) in Quality Control Laboratory. Operation and Calibration of Melting Point Apparatus 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for operation, calibration and maintenance of […]

Laboratory Oven – SOP for Operation & Maintenance

July 18, 2020 July 18, 2020 pharmabeginers Calibration, GLP, Maintenance Sops, QC Sop, Quality Control, SOPs Drying Oven, Glassware Drying, Lab Oven SOP, LOD Oven, Oven SOPLeave a Comment

Standard Operating Procedure (SOP) for operation and maintenance of Laboratory Oven used for glassware dying or Loss on Drying etc. in quality control laboratory. SOP for Laboratory Oven 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for the operation and maintenance of a laboratory oven. 2.0 SCOPE: This SOP is applicable […]

Bursting Strength Tester – Operation & Calibration

July 15, 2020 June 20, 2020 pharmabeginers 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

July 13, 2020 June 16, 2020 pharmabeginers 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

July 11, 2020 June 15, 2020 pharmabeginers 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

July 8, 2020 June 13, 2020 pharmabeginers 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

July 6, 2020 June 13, 2020 pharmabeginers 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

July 4, 2020 June 12, 2020 pharmabeginers 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 […]

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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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