Author: Auditor

SOP for Environmental Monitoring in the Manufacturing Area

SOP for Environmental Monitoring in the Manufacturing Area Standard Operating Procedure for Environmental Monitoring in the Manufacturing Area 1) Purpose The purpose of this SOP is to establish procedures for monitoring and controlling the environmental conditions within the pharmaceutical manufacturing area to ensure compliance with regulatory requirements and maintain product quality. 2) Scope This SOP…

Injectables

SOP for Particle Size Distribution in Gels

SOP for Particle Size Distribution in Gels Standard Operating Procedure for Particle Size Distribution in Gels 1) Purpose The purpose of this SOP is to establish procedures for measuring and evaluating the particle size distribution of gels to ensure consistency and quality control during manufacturing. 2) Scope This SOP applies to all personnel involved in…

Gels

SOP for Maintenance of Refrigeration Units

SOP for Maintenance of Refrigeration Units Standard Operating Procedure for Maintenance of Refrigeration Units 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of refrigeration units to ensure optimal performance and reliability in storing pharmaceutical products. 2) Scope This SOP applies to all refrigeration units used in pharmaceutical…

Maintenance Dept.

SOP for Multi-sourcing and Supplier Diversification

SOP for Multi-sourcing and Supplier Diversification Multi-sourcing and Supplier Diversification – Standard Operating Procedure 1) Purpose To establish a standardized process for implementing multi-sourcing and supplier diversification strategies to mitigate risks, ensure supply continuity, and enhance competitiveness within the pharmaceutical purchase department. 2) Scope This SOP applies to all sourcing activities and supplier management practices…

Purchase Departments

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…

Gels

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…

Gels

SOP for Laboratory Notebook Management

SOP for Laboratory Notebook Management Standard Operating Procedure for Laboratory Notebook Management 1) Purpose This SOP outlines the procedures for maintaining laboratory notebooks to ensure accurate, complete, and traceable documentation of experimental procedures, observations, and results in pharmaceutical research and development. 2) Scope This SOP applies to all laboratory personnel responsible for maintaining laboratory notebooks…

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…

Gels

Quality Assurance: SOP for Documentation of Stability Data for Gels

SOP for Documentation of Stability Data for Gels Standard Operating Procedure for Documentation of Stability Data for Gels 1) Purpose The purpose of this SOP is to establish procedures for documenting stability data of gels to ensure accurate recording, evaluation, and reporting of product stability over time. 2) Scope This SOP applies to the Quality…

Quality Assurance

SOP for Maintenance of Laboratory Equipment

SOP for Maintenance of Laboratory Equipment Standard Operating Procedure for Maintenance of Laboratory Equipment 1) Purpose The purpose of this SOP is to establish the procedures for the routine maintenance of laboratory equipment to ensure accuracy and reliability in analytical testing and research activities in the pharmaceutical industry. 2) Scope This SOP applies to all…

Maintenance Dept.