Author: Auditor

Quality Assurance: SOP for Personnel Hygiene in Gels Production

SOP for Personnel Hygiene in Gels Production Standard Operating Procedure for Personnel Hygiene in Gels Production 1) Purpose The purpose of this SOP is to establish guidelines and procedures for maintaining hygiene practices among personnel working in the gels production area to prevent contamination and ensure product quality and safety. 2) Scope This SOP applies…

Quality Assurance

SOP for Procurement Audit and Review

SOP for Procurement Audit and Review Procurement Audit and Review – Standard Operating Procedure 1) Purpose To establish a standardized process for conducting audits and reviews of procurement activities to ensure compliance with internal policies, regulatory requirements, and continuous improvement within the pharmaceutical purchase department. 2) Scope This SOP applies to all procurement activities and…

Purchase Departments

Quality Assurance: SOP for Environmental Monitoring in Gels Production

SOP for Environmental Monitoring in Gels Production Standard Operating Procedure for Environmental Monitoring in Gels Production 1) Purpose The purpose of this SOP is to outline procedures for monitoring and controlling the environmental conditions within the gels production area to ensure product quality, safety, and compliance with regulatory requirements. 2) Scope This SOP applies to…

Quality Assurance

Injectables: SOP for Batch Documentation for FFS Operations

SOP for Batch Documentation for FFS Operations Standard Operating Procedure for Batch Documentation for FFS Operations 1) Purpose The purpose of this SOP is to establish guidelines for the preparation, review, and maintenance of batch documentation related to Form-Fill-Seal (FFS) operations in pharmaceutical manufacturing. 2) Scope This SOP applies to all batch documentation activities for…

Injectables

Quality Assurance: SOP for Documentation Control in Gels Production

SOP for Documentation Control in Gels Production Standard Operating Procedure for Documentation Control in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for the creation, revision, distribution, storage, and retention of documents related to gels production to ensure accuracy, traceability, and compliance with regulatory requirements. 2) Scope This SOP applies…

Quality Assurance

SOP for Process Optimization for Gels

SOP for Process Optimization for Gels Standard Operating Procedure for Process Optimization for Gels 1) Purpose The purpose of this SOP is to establish procedures for optimizing the manufacturing processes used in the production of gels to enhance efficiency, product quality, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved…

Gels

Quality Assurance: SOP for Change Control in Gels Production

SOP for Change Control in Gels Production Standard Operating Procedure for Change Control in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for initiating, evaluating, approving, and implementing changes to processes, equipment, facilities, and systems in gels production to ensure controlled and documented changes. 2) Scope This SOP applies to…

Quality Assurance

Quality Assurance: SOP for Cleaning Validation in Gels Production

SOP for Cleaning Validation in Gels Production Standard Operating Procedure for Cleaning Validation in Gels Production 1) Purpose The purpose of this SOP is to establish procedures for validating the cleaning process of equipment and facilities used in gels production to ensure removal of residues and prevent cross-contamination. 2) Scope This SOP applies to all…

Quality Assurance

SOP for Calibration of Balances and Scales

SOP for Calibration of Balances and Scales Standard Operating Procedure for Calibration of Balances and Scales 1) Purpose The purpose of this SOP is to establish the procedures for calibrating balances and scales to ensure accuracy and reliability in weighing measurements as per regulatory requirements in the pharmaceutical industry. 2) Scope This SOP applies to…

Maintenance Dept.

SOP for Formulation Development for Gels

SOP for Formulation Development for Gels Standard Operating Procedure for Formulation Development for Gels 1) Purpose The purpose of this SOP is to outline procedures for the development and optimization of formulations for gels to achieve desired product characteristics and quality attributes. 2) Scope This SOP applies to all personnel involved in formulation development activities…

Gels