SOP for Emergency Response and Evacuation: Instructions for Handling Emergencies, Including Evacuation Procedures, Contact Information, and Emergency Equipment Locations 1) SOP for Emergency Response and Evacuation 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide instructions for handling emergencies, including evacuation procedures, contact information, and emergency equipment locations within the pharmaceutical…

SOP for Training and Competency: Requirements for Training Employees, Maintaining Training Records, and Assessing Competency in Various Manufacturing Tasks 1) SOP for Training and Competency 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the requirements for training employees, maintaining training records, and assessing competency in various manufacturing tasks within the…

SOP for Handling of Deviations and Incidents: Procedures for Identifying, Documenting, and Investigating Deviations, Incidents, or Non-conformances in the Manufacturing Process 1) SOP for Handling Deviations and Incidents 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish procedures for identifying, documenting, and investigating deviations, incidents, or non-conformances that occur during the…

SOP for Out of Specification (OOS) Investigations: Steps for Investigating and Addressing Test Results that Fall Outside Established Specifications 1) SOP for OOS Investigations 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the steps for investigating and addressing test results that fall outside established specifications (Out of Specification or OOS…

SOP for Quality Assurance and Quality Control (QA/QC) Communication: Guidelines for Communication Between QA and QC Departments, Including Reporting of Deviations and Investigations 1) SOP for QA/QC Communication 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for effective communication between the Quality Assurance (QA) and Quality Control (QC) departments…

SOP for Batch Release and Product Disposition: Procedures for Reviewing and Releasing Finished Batches for Distribution and Ensuring Product Disposition 1) SOP for Batch Release and Product Disposition 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for reviewing and releasing finished batches of products for distribution, and ensuring…

SOP for Reconciliation of Materials: Steps to Reconcile the Quantities of Raw Materials Used with What Was Planned and What Remains After Production 1) SOP for Reconciliation of Materials 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the steps required to reconcile the quantities of raw materials used in production…

SOP for Material Handling and Storage: Guidelines for the Proper Handling, Storage, and Labelling of Raw Materials and Intermediates 1) SOP for Material Handling and Storage 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the proper handling, storage, and labelling of raw materials and intermediates to prevent contamination,…

SOP for Change Control Procedures: Procedures for Requesting, Evaluating, and Implementing Changes to Equipment, Processes, or Materials 1) SOP for Change Control Procedures 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for requesting, evaluating, approving, and implementing changes to equipment, processes, or materials to ensure that all changes…

SOP for Equipment Calibration and Maintenance: Procedures for Regular Calibration and Maintenance of Equipment 1) SOP for Equipment Calibration and Maintenance 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the regular calibration and maintenance of equipment used in pharmaceutical manufacturing to ensure accuracy, reliability, and compliance with regulatory…