Author: Auditor

Injectables: SOP for Handling Deviations during Manufacturing

SOP for Handling Deviations during Manufacturing Standard Operating Procedure for Handling Deviations during Manufacturing 1) Purpose The purpose of this SOP is to establish procedures for identifying, documenting, evaluating, and resolving deviations encountered during pharmaceutical manufacturing processes to ensure product quality and compliance. 2) Scope This SOP applies to all personnel involved in the detection,…

Injectables

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…

Gels

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…

Gels

SOP for Continuous Improvement Programs

SOP for Continuous Improvement Programs Standard Operating Procedure for Continuous Improvement Programs 1) Purpose This SOP outlines the procedures for implementing and managing continuous improvement programs to enhance efficiency, effectiveness, and compliance within the pharmaceutical facility. 2) Scope This SOP applies to all departments and personnel involved in identifying, implementing, and monitoring continuous improvement initiatives…

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…

Gels

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…

Gels

SOP for Maintenance of Sterilization Equipment

SOP for Maintenance of Sterilization Equipment Standard Operating Procedure for Maintenance of Sterilization Equipment 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of sterilization equipment to ensure proper sterilization and operational reliability in the pharmaceutical manufacturing process. 2) Scope This SOP applies to all sterilization equipment used…

Maintenance Dept.

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…

Gels

SOP for Process Validation Protocols for Gels

SOP for Process Validation Protocols for Gels Standard Operating Procedure for Process Validation Protocols for Gels 1) Purpose The purpose of this SOP is to define the procedures for conducting process validation protocols for gels production to ensure consistent product quality, reliability, and compliance with regulatory requirements. 2) Scope This SOP applies to all stages…

Gels

SOP for Quality Metrics and Reporting

SOP for Quality Metrics and Reporting Standard Operating Procedure for Quality Metrics and Reporting 1) Purpose This SOP outlines the procedures for establishing, measuring, analyzing, and reporting quality metrics to monitor and improve processes, products, and systems within the pharmaceutical facility. 2) Scope This SOP applies to all departments and personnel involved in the collection,…

Quality Assurance