Tag: Capsule Manufacturing

SOP for Handling of Deviations and Incidents: Procedures for Identifying, Documenting, and Investigating Deviations, Incidents, or Non-conformances in the Manufacturing Process

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…

Capsule Formulation

SOP for Out of Specification (OOS) Investigations: Steps for Investigating and Addressing Test Results that Fall Outside Established Specifications

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…

Capsule Formulation

SOP for Quality Assurance and Quality Control (QA/QC) Communication: Guidelines for Communication Between QA and QC Departments, Including Reporting of Deviations and Investigations

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…

Capsule Formulation

SOP for Batch Release and Product Disposition: Procedures for Reviewing and Releasing Finished Batches for Distribution and Ensuring Product Disposition

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…

Capsule Formulation

SOP for Reconciliation of Materials: Steps to Reconcile the Quantities of Raw Materials Used with What Was Planned and What Remains After Production

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…

Capsule Formulation

SOP for Material Handling and Storage: Guidelines for the Proper Handling, Storage, and Labelling of Raw Materials and Intermediates

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,…

Capsule Formulation

SOP for Change Control Procedures: Procedures for Requesting, Evaluating, and Implementing Changes to Equipment, Processes, or Materials

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…

Capsule Formulation

SOP for Equipment Calibration and Maintenance: Procedures for Regular Calibration and Maintenance of Equipment

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…

Capsule Formulation

SOP for Sampling and Retention of Samples: Guidelines for Taking Representative Samples of Materials and Products for Testing and Analysis

SOP for Sampling and Retention of Samples: Guidelines for Taking Representative Samples of Materials and Products for Testing and Analysis 1) SOP for Sampling and Retention of Samples 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide detailed guidelines for taking representative samples of raw materials, in-process materials, and finished products…

Capsule Formulation

SOP for Cleaning Verification: Guidelines for Verifying the Cleaning Process of Equipment to Ensure No Contamination

SOP for Cleaning Verification: Guidelines for Verifying the Cleaning Process of Equipment to Ensure No Contamination 1) SOP for Cleaning Verification 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for verifying the cleaning process of equipment used in pharmaceutical manufacturing to ensure no contamination and compliance with regulatory standards….

Capsule Formulation