Author: Auditor

SOP for Calibration and Maintenance: Procedures for Calibrating and Maintaining Equipment

SOP for Calibration and Maintenance: Procedures for Calibrating and Maintaining Equipment Calibration and Maintenance Procedures 1) Purpose The purpose of this SOP is to establish standardized procedures for calibrating and maintaining equipment to ensure accurate and reliable performance. 2) Scope This SOP applies to all equipment used in the pharmaceutical manufacturing facility that requires calibration…

Capsule Formulation

SOP for Assay Testing of Active Pharmaceutical Ingredient (API)

SOP for Assay Testing of Active Pharmaceutical Ingredient (API) Procedure for Assay Testing of Active Pharmaceutical Ingredient (API) 1) Purpose The purpose of this SOP is to outline the procedure for conducting assay testing on Active Pharmaceutical Ingredients (APIs) to ensure their potency and quality meet specified standards. 2) Scope This SOP applies to all…

In-Process Control

SOP for Environmental Monitoring in Ointment Formulation

SOP for Environmental Monitoring in Ointment Formulation Standard Operating Procedure for Environmental Monitoring in Ointment Formulation 1) Purpose The purpose of this SOP is to establish procedures for environmental monitoring in ointment formulation areas to ensure cleanliness, control microbial contamination, and maintain product quality and safety. 2) Scope This SOP applies to all personnel involved…

Ointments

In-Process Control: SOP for Pyrogen Testing

SOP for Pyrogen Testing Procedure for Pyrogen Testing 1) Purpose The purpose of this SOP is to outline the procedure for performing pyrogen testing on pharmaceutical products to ensure they are free from pyrogenic contaminants and safe for patient use. 2) Scope This SOP applies to all pharmaceutical products manufactured within the facility that require…

In-Process Control

SOP for Document Control: Procedures for Managing the Creation, Approval, Distribution, and Archiving of Documents

SOP for Document Control: Procedures for Managing the Creation, Approval, Distribution, and Archiving of Documents Document Control Procedures 1) Purpose The purpose of this SOP is to establish standardized procedures for managing the creation, approval, distribution, and archiving of documents to ensure accurate and up-to-date documentation within the pharmaceutical manufacturing facility. 2) Scope This SOP…

Capsule Formulation

SOP for Sealing and Capping of Vials

SOP for Sealing and Capping of Vials Standard Operating Procedure for Sealing and Capping of Vials 1) Purpose The purpose of this SOP is to define the procedures for sealing and capping vials to ensure the integrity and sterility of injection products. 2) Scope This SOP applies to all personnel involved in sealing and capping…

Injectables

In-Process Control: SOP for Sterility Testing

SOP for Sterility Testing Procedure for Sterility Testing 1) Purpose The purpose of this SOP is to outline the procedure for performing sterility testing on pharmaceutical products to ensure they are free from viable microorganisms and safe for patient use. 2) Scope This SOP applies to all pharmaceutical products manufactured within the facility that require…

In-Process Control

SOP for Cleaning and Sanitation: Procedures for Cleaning and Sanitizing Equipment and Facilities

SOP for Cleaning and Sanitation: Procedures for Cleaning and Sanitizing Equipment and Facilities Cleaning and Sanitation Procedures 1) Purpose The purpose of this SOP is to establish standardized procedures for cleaning and sanitizing equipment and facilities to ensure a hygienic manufacturing environment and prevent contamination. 2) Scope This SOP applies to all equipment and facilities…

Capsule Formulation

SOP for Endotoxin Testing in Injectable Products

SOP for Endotoxin Testing in Injectable Products Procedure for Endotoxin Testing in Injectable Products 1) Purpose The purpose of this SOP is to outline the procedure for conducting endotoxin testing on injectable products to ensure compliance with regulatory requirements and patient safety. 2) Scope This SOP applies to all injectable products manufactured within the facility…

In-Process Control

SOP for Investigation and CAPA in Ointment Formulation

SOP for Investigation and CAPA in Ointment Formulation Standard Operating Procedure for Investigation and Corrective Action Preventive Action (CAPA) in Ointment Formulation 1) Purpose The purpose of this SOP is to establish procedures for conducting investigations, implementing corrective actions, and preventive actions (CAPA) related to deviations, incidents, complaints, or non-conformances in ointment formulation processes or…

Ointments