Handling of Hold Time Drug Samples
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
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)
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
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
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
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
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
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
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
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
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
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 […]
Procedure for using of Molybdenum Kit
Standard Operating Procedure (SOP) for using of Molybdenum Kit, This kit is used to check the content of molybdenum in stainless steel. Procedure for using of Molybdenum Kit 1.0 PURPOSE: The purpose of this SOP is to provide a guideline for carrying out the test of Stainless Steel (SS) surface with the Molybdenum […]
SOP for Line Clearance (LC) of Area and Equipments
Standard Operating Procedure (SOP) for Line Clearance (LC) of the manufacturing area and equipment at the different stages of drug product manufacturing and packing in a pharmaceutical manufacturing plant. Procedure for Line Clearance of Area and Equipment 1.0 PURPOSE : The purpose of this SOP (Standard Operating Procedure) is to describe the procedure […]
SOP for Incident / Deviation Management
Standard Operating Procedure (SOP) for Handling and Management of Incident / Deviation under the Quality Management System (QMS) in a pharmaceutical plant. Handling and Control Procedure for Incident / Deviation 1.0 PURPOSE: This Standard Operating Procedure (SOP) defines the key elements and requirements for reporting, documenting, evaluating, managing and resolving deviations/incidents from cGxPs […]
Bursting Strength Tester – Operation & Calibration
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
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
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
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
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
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
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
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
.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
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
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
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 […]
Bursting Strength Tester – Operation & Calibration
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
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
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
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
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
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
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
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
.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
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
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
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 […]
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