Author: Auditor

SOP for Material Specification and Quality Requirements

SOP for Material Specification and Quality Requirements Material Specification and Quality Requirements – Standard Operating Procedure 1) Purpose To define the process for establishing material specifications and quality requirements to ensure consistency and compliance in procurement. 2) Scope This SOP applies to the specification and quality requirements for materials purchased by the pharmaceutical purchase department….

Purchase Departments

SOP for Temperature Mapping of Storage Areas

SOP for Temperature Mapping of Storage Areas Procedure for Temperature Mapping of Storage Areas 1) Purpose The purpose of this SOP is to outline the procedure for conducting temperature mapping studies in storage areas to ensure uniformity and stability of temperature conditions for stored pharmaceutical products. 2) Scope This SOP applies to all storage areas…

In-Process Control

Quality Assurance: SOP for Change Control Management

SOP for Change Control Management Standard Operating Procedure for Change Control Management 1) Purpose This SOP outlines the procedures for initiating, evaluating, implementing, and documenting changes to processes, systems, facilities, equipment, and documents to ensure controlled and systematic change management while maintaining compliance with regulatory requirements. 2) Scope This SOP applies to all departments and…

Quality Assurance

SOP for Particle Count Testing in Cleanrooms

SOP for Particle Count Testing in Cleanrooms Procedure for Particle Count Testing in Cleanrooms 1) Purpose The purpose of this SOP is to outline the procedure for conducting particle count testing in cleanrooms to monitor airborne particulate levels and ensure compliance with specified cleanliness standards. 2) Scope This SOP applies to all cleanrooms and controlled…

In-Process Control

SOP for Vendor Communication Protocols

SOP for Vendor Communication Protocols Vendor Communication Protocols – Standard Operating Procedure 1) Purpose To establish clear protocols and guidelines for effective communication with vendors to ensure timely and accurate exchange of information. 2) Scope This SOP applies to all communication activities with vendors within the pharmaceutical purchase department. 3) Responsibilities Purchasing Team: Responsible for…

Purchase Departments

SOP for Raw Material Testing and Approval

SOP for Raw Material Testing and Approval Standard Operating Procedure for Raw Material Testing and Approval 1) Purpose The purpose of this SOP is to establish procedures for the testing and approval of raw materials to ensure they meet specified quality standards before use in the manufacturing process. 2) Scope This SOP applies to all…

Injectables

SOP for CAPA (Corrective and Preventive Actions)

SOP for CAPA (Corrective and Preventive Actions) Standard Operating Procedure for CAPA (Corrective and Preventive Actions) 1) Purpose This SOP outlines the procedures for initiating, investigating, implementing, and verifying corrective and preventive actions (CAPA) to address non-conformances, deviations, and potential issues in order to prevent their recurrence. 2) Scope This SOP applies to all departments…

Quality Assurance

SOP for Airflow Visualization Studies

SOP for Airflow Visualization Studies Procedure for Airflow Visualization Studies 1) Purpose The purpose of this SOP is to outline the procedure for conducting airflow visualization studies in cleanrooms to assess and validate the effectiveness of airflows in maintaining specified cleanliness levels. 2) Scope This SOP applies to all cleanrooms and controlled environments within the…

In-Process Control

SOP for Clean Steam Quality Testing

SOP for Clean Steam Quality Testing Procedure for Clean Steam Quality Testing 1) Purpose The purpose of this SOP is to outline the procedure for testing the quality of clean steam used in pharmaceutical manufacturing processes to ensure it meets specified standards for purity and suitability. 2) Scope This SOP applies to all stages of…

In-Process Control

SOP for Contract Negotiation and Management

SOP for Contract Negotiation and Management Contract Negotiation and Management – Standard Operating Procedure 1) Purpose To establish guidelines for negotiating contracts with suppliers and managing contract terms to ensure compliance and optimal business outcomes. 2) Scope This SOP applies to contract negotiation and management activities within the pharmaceutical purchase department. 3) Responsibilities Procurement Manager:…

Purchase Departments