Process Standardization and Validation – SOP
Standard Operating Procedure (SOP) for Process Standardization and Validation be carried for the new products and existing products at the formulation plant. SOP for Process Standardization and Validation 1.0 Purpose: To lay down a procedure for process standardization and process validation study. 2.0 Scope – Process Standardization and Validation: The SOP is applicable to process […]
Batch Release Procedure of Finished Product
Standard Operating Procedure (SOP) for approval and release of Finished Product Batch for moving from the manufacturing site to supply chain/distributors or C&F warehouses. Procedure for Finished Product Batch Release 1.0 PURPOSE: To lay down the procedure for approval and release of the finished product batch. 2.0 SCOPE: This Standard Operating Procedure is applicable for […]
Cleaning Validation (CV) Procedure – SOP
Standard Operating Procedure (SOP) for Cleaning Validation (CV) in the pharmaceutical drug manufacturing plants. Cleaning Validation (CV) is the documented evidence that an approved cleaning procedure is consistent in reducing product residue and removal of cleaning agents (if any), bioburden, flavor (if any), color (if any) from equipment and accessories within the acceptance level. Procedure […]
Handling Power Failure Situation (SOP) in Plant
Standard Operating Procedure (SOP) for Handling Power Failure situations in different areas like Production, Quality Contro, Microbiology, Utility, Stores, etc at the pharmaceutical drug manufacturing plant. Procedure for Handling of Power Failure in Pharma 1.0 Purpose: To lay down a procedure for handling power failure situations. 2.0 Scope: This procedure is applicable to handling power […]
Media Fill Validation – SOP for Process Simulation
Standard Operating Procedure (SOP) for Media Fill Validation in Sterile facility. A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution. The microbiological growth medium is used in place of the drug solution during media fills […]
Good Chromatography Practices – SOP & Guideline
Chromatography is a laboratory technique for the separation of a mixture. The mixture is dissolved in a fluid called the mobile phase, which carries it through a structure holding another material called the stationary phase. The various constituents of the mixture travel at different speeds, causing them to separate. GOOD CHROMATOGRAPHY PRACTICES 1.0 PURPOSE : The […]
HVAC System Qualification Protocol (Validation)
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
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
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
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
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
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
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 […]
Environment, Health And Safety Policy (EHS) – SOP
The EHS policy is a guiding principle used to set direction in an organization. It is used for a course of action to guide and influence decisions. It should be used as a guide to decision making under a given set of circumstances within the framework of objectives, goals, and management philosophies as determined by […]
Good Laboratory Practices (GLP) – SOP & Guideline
Standard Operating Procedure SOP for Good Laboratory Practices (GLP) in line with the Schedule L1 requirement of the drug and cosmetic act. Good Laboratory Practices (GLP) embodies a set of principles that provides a framework within which laboratory studies (activities) are planned, performed, monitored, recorded, reported, and archived. Good Laboratory Practices (GLP) 1.0 Purpose: The […]
Safety at Workplace – SOP for Safety Management
Safety at Workplace related to the working environment at a company and encompasses all factors that impact the safety and health of employees. This can include environmental hazards, unsafe working conditions or processes, drug and alcohol abuse, and workplace violence. Safety at Workplace – SOP for Safety Management 1.0 PURPOSE: This procedure will provide guidance […]
Investigation of Extraneous Peak in Chromatography
Standard Operating Procedure (SOP) for Handling and Investigation of Extraneous Peak(s) in Chromatography Analysis. What are the Extraneous Peaks: A peak response in the chromatogram that is not readily attributable as a characteristic of the injection profiles of the blank, mobile phase, diluting solvent, placebo, standard, or sample solutions. By definition, extraneous means introduced from […]
Handling of Rejected Raw and Packing Materials
Standard Operating Procedure (SOP) for the handling of rejected raw materials and packing materials which are rejected due to the Non-conformance of Quality Standards, Online rejection, or Improper storage. Handling of Rejected Materials (Raw Material & Packing Material) 1.0 Purpose: To define the procedure for the handling of rejected materials (Raw Material & Packing Material). […]
Reconciliation of Packing Materials and Bulk-SOP
Standard Operating Procedure (SOP) for reconciliation of packing materials and bulk at the end of the packing of each batch of Drug Product SOP for Reconciliation of Packing Materials 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the detailed procedure for the reconciliation of packing materials and bulk at the […]
Purified Water Plant – Operation and Regeneration
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
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
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
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
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
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 […]
Environment, Health And Safety Policy (EHS) – SOP
The EHS policy is a guiding principle used to set direction in an organization. It is used for a course of action to guide and influence decisions. It should be used as a guide to decision making under a given set of circumstances within the framework of objectives, goals, and management philosophies as determined by […]
Good Laboratory Practices (GLP) – SOP & Guideline
Standard Operating Procedure SOP for Good Laboratory Practices (GLP) in line with the Schedule L1 requirement of the drug and cosmetic act. Good Laboratory Practices (GLP) embodies a set of principles that provides a framework within which laboratory studies (activities) are planned, performed, monitored, recorded, reported, and archived. Good Laboratory Practices (GLP) 1.0 Purpose: The […]
Safety at Workplace – SOP for Safety Management
Safety at Workplace related to the working environment at a company and encompasses all factors that impact the safety and health of employees. This can include environmental hazards, unsafe working conditions or processes, drug and alcohol abuse, and workplace violence. Safety at Workplace – SOP for Safety Management 1.0 PURPOSE: This procedure will provide guidance […]
Investigation of Extraneous Peak in Chromatography
Standard Operating Procedure (SOP) for Handling and Investigation of Extraneous Peak(s) in Chromatography Analysis. What are the Extraneous Peaks: A peak response in the chromatogram that is not readily attributable as a characteristic of the injection profiles of the blank, mobile phase, diluting solvent, placebo, standard, or sample solutions. By definition, extraneous means introduced from […]
Handling of Rejected Raw and Packing Materials
Standard Operating Procedure (SOP) for the handling of rejected raw materials and packing materials which are rejected due to the Non-conformance of Quality Standards, Online rejection, or Improper storage. Handling of Rejected Materials (Raw Material & Packing Material) 1.0 Purpose: To define the procedure for the handling of rejected materials (Raw Material & Packing Material). […]
Reconciliation of Packing Materials and Bulk-SOP
Standard Operating Procedure (SOP) for reconciliation of packing materials and bulk at the end of the packing of each batch of Drug Product SOP for Reconciliation of Packing Materials 1.0 PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to describe the detailed procedure for the reconciliation of packing materials and bulk at the […]
Purified Water Plant – Operation and Regeneration
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
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
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
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
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
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 […]
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