Author: Auditor

Quality Assurance: SOP for Good Manufacturing Practices (GMP) Compliance

SOP for Good Manufacturing Practices (GMP) Compliance Standard Operating Procedure for Good Manufacturing Practices (GMP) Compliance 1) Purpose This SOP outlines the procedures for ensuring compliance with Good Manufacturing Practices (GMP) to consistently produce pharmaceutical products that meet quality and regulatory requirements. 2) Scope This SOP applies to all personnel involved in the manufacturing, packaging,…

Quality Assurance

SOP for Stability-Indicating Methods Development for Gels

SOP for Stability-Indicating Methods Development for Gels Standard Operating Procedure for Stability-Indicating Methods Development for Gels 1) Purpose The purpose of this SOP is to establish procedures for the development and validation of stability-indicating analytical methods for gels, ensuring accurate assessment of stability and quality attributes over time in compliance with regulatory requirements. 2) Scope…

Gels

SOP for Customer Complaints Handling for Gels

SOP for Customer Complaints Handling for Gels Standard Operating Procedure for Customer Complaints Handling for Gels 1) Purpose The purpose of this SOP is to establish procedures for the receipt, documentation, investigation, and resolution of customer complaints related to gels, ensuring timely response, investigation of root causes, and implementation of corrective actions to improve product…

Gels

SOP for Inventory Management

SOP for Inventory Management Inventory Management – Standard Operating Procedure 1) Purpose To establish a standardized process for managing inventory levels effectively, ensuring adequate stock availability while minimizing excess inventory within the pharmaceutical purchase department. 2) Scope This SOP applies to all inventory management activities, including stock monitoring, replenishment, storage, and inventory record-keeping. 3) Responsibilities…

Purchase Departments

SOP for Maintenance of Fume Hoods and Laminar Flow Hoods

SOP for Maintenance of Fume Hoods and Laminar Flow Hoods Standard Operating Procedure for Maintenance of Fume Hoods and Laminar Flow Hoods 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of fume hoods and laminar flow hoods to ensure safe and effective containment of hazardous substances in…

Maintenance Dept.

SOP for Recall Procedure for Gels

SOP for Recall Procedure for Gels Standard Operating Procedure for Recall Procedure for Gels 1) Purpose The purpose of this SOP is to establish procedures for the initiation, execution, and documentation of product recalls for gels to promptly remove products from the market that pose a risk to public health or do not meet quality…

Gels

Quality Assurance: Quality Assurance: SOP for Good Manufacturing Practices (GMP) Compliance

Quality Assurance

SOP for Post-Market Surveillance for Gels

SOP for Post-Market Surveillance for Gels Standard Operating Procedure for Post-Market Surveillance for Gels 1) Purpose The purpose of this SOP is to establish procedures for conducting post-market surveillance (PMS) activities for gels to monitor their safety, efficacy, and performance in real-world use, and to ensure compliance with regulatory requirements. 2) Scope This SOP applies…

Gels

SOP for Regulatory Submission for Gels

SOP for Regulatory Submission for Gels Standard Operating Procedure for Regulatory Submission for Gels 1) Purpose The purpose of this SOP is to establish procedures for the preparation, compilation, and submission of regulatory documents related to gels to regulatory authorities, ensuring compliance with applicable laws, regulations, and guidelines. 2) Scope This SOP applies to all…

Gels

SOP for Maintenance of Dehumidifiers

SOP for Maintenance of Dehumidifiers Standard Operating Procedure for Maintenance of Dehumidifiers 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of dehumidifiers to ensure optimal humidity control in pharmaceutical manufacturing and storage areas. 2) Scope This SOP applies to all dehumidifiers used in pharmaceutical manufacturing facilities, laboratories,…

Maintenance Dept.