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List of SOP for Pharmaceutical Industry

 

Standard Operating Procedure (SOP) in Pharmaceutical Industry

A SOP is a verified and approved document to execute the operations in a standard manner. In pharmaceutical industry a SOP is a heart of the quality system. Any violation of SOP is a major regulatory observation in pharma industry.

The importance of SOP in pharmaceutical industry is to maintain the pharmaceutical quality management system (QMS), that ensure the product quality and patient safety.

Writing an effective Standard operating procedures (SOPs) is fundamental QA responsibility for highly regulated industries such as pharmaceutical and biologics industries. It is the requirement of regulatory authorities.

It is also requires a clear understanding of the task or process being described, as well as a clear and concise writing style. SOPs should be written in a step-by-step format and should include detailed instructions, as well as any relevant safety information or regulatory requirements.

It is important to regularly review and update SOPs to ensure that they remain accurate and relevant, and that they continue to reflect the current processes and best practices of the organization.

In this article we try to list out the name of major SOP of pharmaceutical industry including R&D, QC, QA and Production.

A List of R&D SOP in Pharma Industry

Formulation

SOP for Entry and Exit Procedure for Formulation Laboratory

SOP for Gowning procedure for Formulation laboratory

SOP for Formulation Development of New drug Product

SOP for Procedure for Documentation in Laboratory Notebook

SOP for Trial Batch Numbering

SOP for Procedure for Manufacturing and Testing of Submission/ Exhibit Batches for Regulated Markets

SOP for Preparation, Review and Approval of Unit Formula and Master Formula

SOP for Technology Transfer Procedure

SOP for Procedure for Reference Products Characterization

SOP for Procedure for sample submission for Analysis

SOP for Procedure for Stability Study Initiation

SOP for Daily accuracy check of weighing Balances

SOP for Issuance and Control of Barcode and Pharmacode Numbering System

SOP for Preparation and Approval of Specification of Packaging Materials 

SOP for Handling of Materials for External Technology Transfer and R & D Projects

SOP for Waste Materials Disposal Procedure

SOP for Technical Feasibility Study of Drug Products

SOP for Preparation, Review and Approval of Batch Manufacturing Record for Process Optimization

SOP for Process Optimization Batch Manufacturing

SOP for Preparation of Product Specification 

SOP for Procedure for shelf life determination of products 

Related: List of Production SOP in Pharmaceutical Industry

Analytical

SOP for Gowning Procedure Analytical Laboratory

SOP for Entry and Exit Procedure For Analytical Laboratory

SOP for Labeling of Prepared Chemical Reagents, Media/Solutions in Analytical Laboratory

SOP for Handling of Equipment Operation Logbook of Analytical Laboratory

SOP for Stock Control and Rotation of Laboratory Chemicals, Reagents and Accessories in Analytical Laboratory

SOP for Glassware Washing and Drying in Analytical Laboratory

SOP for Daily Accuracy Check of Analytical Balances

SOP for Storage, Use and Current Lot Checking of Chemical Reference Substance In Analytical Laboratory

SOP for Procedure for Issuance, Recording and Control of Laboratory Notebook and Analytical Worksheet in Analytical Laboratory

SOP for Handling of Working Standards in Analytical Laboratory

SOP for Receipt, Store, Use, Reconciliation and Disposal of Sample in Analytical Laboratory

SOP for Good Chromatographic Practices in Analytical Laboratory

SOP for Procedure for selection of chromatographic columns in Analytical Laboratory

SOP for Procedure For Laboratory Analyst Performance Assessment and Validation in Analytical Laboratory

SOP for Temperature Monitoring in Analytical Laboratory

SOP for Procedure for Regeneration of Silica Gel and Replacement of Molecular Sieve

SOP for Procedure for HPLC/GC/IC Column Management in Analytical Laboratory

SOP for Project Management and Data Integration on Empower and Chromeleon in Analytical Laboratory

SOP for Procedure for Column Washing of HPLC and GC in Analytical Laboratory

SOP for Preparation, Review, Approval and Control of  Specification and standard Test Procedures in Analytical Laboratory

SOP for Analytical Data Review in Analytical Laboratory

Related: List of Quality Control SOP in Pharma

SOP for Analytical Method Transfer

SOP for Analytical Method Validation/Verification

SOP for Laboratory Incident Report

SOP for Procedure for Recovery Efficiency Determination for Cleaning validation

SOP for Procedure for Protocol Based Study in Analytical Laboratory

SOP for Preparation, Control and Verification of Microsoft Excel Spreadsheets in Analytical Laboratory

SOP for Preventive Maintenance of Laboratory Equipment in Analytical Laboratory

SOP for Analytical Method Validation/Verification 

SOP for Analytical Method Transfer 

SOP for Laboratory Analyst Validation 

SOP for Good Laboratory Practices

SOP for Analytical Data Review in Analytical Method Validation

SOP for Reporting of Incidents in Analytical Method Validation Laboratory 

SOP for Good Chromatographic Practices in Analytical Method Validation

SOP for Storage and Use of Chemical Reference Substances in Analytical Method Validation Laboratory

SOP for Handling of Working Standards in Analytical Method Validation Laboratory

SOP for Project Management and Data Integration on Empower and Chromeleon in Analytical Method Validation Laboratory

SOP for Procedure for Issuance, Recording and Control of Laboratory Notebook in Analytical Method Validation

SOP for Labeling, Storage and Expiry Dating of Prepared Chemical Reagents and Media / Solutions in Analytical Method Validation Laboratory

SOP for Analytical Balance Accuracy Check 

SOP for Procedure for Recovery Efficiency Determination for Cleaning Validation and Cross-Contamination 

SOP for Receiving, Store, Use, Reconciliation and Disposal of Sample in Analytical Method Validation

SOP for Stock Control and Rotation of Laboratory Chemicals , Reagents and Accessories in Analytical Method Validation

SOP for Handling of Equipment Operation Logbook of Analytical Method Validation 

SOP for Glassware Washing and Drying in Analytical Method Validation Laboratory 

SOP for Temperature Monitoring in Analytical Method Validation 

SOP for Procedure for Regeneration of Silica Gel 

SOP for Calculations and Rounding off Significant Figures in Analytical Method Validation 

SOP for Procedure for Column Washing of HPLC and GC in Analytical Method Validation

SOP for Procedure for HPLC/GC/IC Column Management in Analytical Method Validation

SOP for Maintenance and Review of Audit Trial of Electronically Generated Data

SOP for Procedure for Reviewer Qualification in Analytical Method Validation

SOP for Control of Calculation Sheet Used in Analytical Method Validation Laboratory

SOP for Preparation, Control and Verification of Microsoft Excel Spreadsheets in Analytical Method Validation Laboratory


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