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.

Read also: Important Elements to Consider for SOP Preparation

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

Read also: 

• List of Quality Assurance SOP for Pharmaceutical Industry

• List of Pharmaceutical Engineering SOP
  

• SOP for User Requirement Specification (URS)