The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Electronic Records and Signatures Standard Operating Procedure for Electronic Records and Signatures 1) Purpose This SOP outlines the procedures for managing electronic records and signatures in pharmaceutical manufacturing to ensure compliance with regulatory requirements for data integrity, authenticity, and traceability. 2) Scope This SOP applies to all electronic records and signatures generated, reviewed,…
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…
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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…
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…
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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…
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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…
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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…
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…
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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…
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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…