Author: Auditor

Quality Assurance: SOP for Risk Management in Gels Production

SOP for Risk Management in Gels Production Standard Operating Procedure for Risk Management in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for identifying, assessing, controlling, and mitigating risks associated with gels production processes, aiming to ensure product quality, patient safety, and compliance with regulatory requirements. 2) Scope This SOP…

Quality Assurance

SOP for Labeling and Coding on FFS Machine

SOP for Labeling and Coding on FFS Machine Standard Operating Procedure for Labeling and Coding on FFS Machine 1) Purpose The purpose of this SOP is to outline the procedures for labeling and coding pharmaceutical products on the Form-Fill-Seal (FFS) machine to ensure accurate product identification and compliance with regulatory requirements. 2) Scope This SOP…

Injectables

SOP for Consistency Testing in Gels

SOP for Consistency Testing in Gels Standard Operating Procedure for Consistency Testing in Gels 1) Purpose The purpose of this SOP is to establish procedures for testing the consistency of gel formulations to ensure uniform texture and performance. 2) Scope This SOP applies to all personnel involved in consistency testing of gel products within the…

Gels

Quality Assurance: SOP for Corrective and Preventive Actions (CAPA) in Gels Production

SOP for Corrective and Preventive Actions (CAPA) in Gels Production Standard Operating Procedure for Corrective and Preventive Actions (CAPA) in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for identifying, documenting, investigating, implementing, and verifying corrective and preventive actions (CAPA) in response to deviations, non-conformances, complaints, or other quality issues…

Quality Assurance

Quality Assurance: SOP for Root Cause Analysis in Gels Production

SOP for Root Cause Analysis in Gels Production Standard Operating Procedure for Root Cause Analysis in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for conducting effective root cause analysis (RCA) of deviations, non-conformances, or quality issues encountered during gels production, aiming to identify underlying causes and implement corrective actions…

Quality Assurance

SOP for Emulsion Stability Testing in Gels

SOP for Emulsion Stability Testing in Gels Standard Operating Procedure for Emulsion Stability Testing in Gels 1) Purpose The purpose of this SOP is to outline procedures for testing the stability of emulsions within gel formulations to ensure product consistency and quality over time. 2) Scope This SOP applies to all personnel involved in the…

Gels

Quality Assurance: SOP for Out of Specification (OOS) Handling in Gels Production

SOP for Out of Specification (OOS) Handling in Gels Production Standard Operating Procedure for Out of Specification (OOS) Handling in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for the identification, investigation, and handling of Out of Specification (OOS) results encountered during gels production, ensuring accurate data interpretation, product quality…

Quality Assurance

SOP for Calibration of Conductivity Meters

SOP for Calibration of Conductivity Meters Standard Operating Procedure for Calibration of Conductivity Meters 1) Purpose The purpose of this SOP is to establish the procedures for calibrating conductivity meters to ensure accuracy and reliability in conductivity measurements as per regulatory requirements in the pharmaceutical industry. 2) Scope This SOP applies to all conductivity meters…

Maintenance Dept.

SOP for IT Systems Used in Procurement

SOP for IT Systems Used in Procurement IT Systems Used in Procurement – Standard Operating Procedure 1) Purpose To establish a standardized process for the utilization, management, and maintenance of IT systems used in the procurement process to ensure efficiency, data accuracy, and compliance within the pharmaceutical purchase department. 2) Scope This SOP applies to…

Purchase Departments

Quality Assurance: SOP for Deviation Handling in Gels Production

SOP for Deviation Handling in Gels Production Standard Operating Procedure for Deviation Handling in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for the identification, documentation, investigation, and resolution of deviations that occur during gels production, ensuring product quality, process integrity, and compliance with regulatory requirements. 2) Scope This SOP…

Quality Assurance