The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Change Control for FFS Machine Standard Operating Procedure for Change Control for FFS Machine 1) Purpose The purpose of this SOP is to establish a systematic approach to managing changes related to the Form-Fill-Seal (FFS) machine to ensure continuity of production, product quality, and regulatory compliance. 2) Scope This SOP applies to all…
SOP for Spare Parts Inventory Management Standard Operating Procedure for Spare Parts Inventory Management 1) Purpose The purpose of this SOP is to establish procedures for managing the inventory of spare parts required for the maintenance of equipment in the pharmaceutical industry to ensure availability and minimize downtime. 2) Scope This SOP applies to all…
SOP for Supplier Confidentiality Agreements Supplier Confidentiality Agreements – Standard Operating Procedure 1) Purpose To establish guidelines for negotiating, executing, and managing confidentiality agreements with suppliers to protect sensitive information within the pharmaceutical purchase department. 2) Scope This SOP applies to all interactions and exchanges of confidential information between the pharmaceutical company and its suppliers….
SOP for Elemental Impurity Testing Standard Operating Procedure for Elemental Impurity Testing 1) Purpose This SOP outlines the procedures for conducting elemental impurity testing on pharmaceutical raw materials and products. 2) Scope This SOP applies to elemental impurity testing of raw materials, intermediate products, and finished pharmaceutical products in the manufacturing facility. 3) Responsibilities The…
SOP for Maintenance Schedule Planning Standard Operating Procedure for Maintenance Schedule Planning 1) Purpose The purpose of this SOP is to outline the procedures for developing and managing a maintenance schedule for equipment and systems used in the pharmaceutical industry to ensure their reliability and compliance with regulatory requirements. 2) Scope This SOP applies to…
SOP for Record Keeping and Documentation Record Keeping and Documentation – Standard Operating Procedure 1) Purpose To establish guidelines for the systematic management, retention, and accessibility of records and documentation within the pharmaceutical purchase department. 2) Scope This SOP applies to all records and documents generated or maintained as part of procurement activities for pharmaceutical…
SOP for Residual Solvent Testing Standard Operating Procedure for Residual Solvent Testing 1) Purpose This SOP outlines the procedures for conducting residual solvent testing on pharmaceutical raw materials and products. 2) Scope This SOP applies to residual solvent testing of raw materials, intermediate products, and finished pharmaceutical products in the manufacturing facility. 3) Responsibilities The…
SOP for Cleaning and Sanitization of FFS Machine Standard Operating Procedure for Cleaning and Sanitization of FFS Machine 1) Purpose The purpose of this SOP is to define the procedure for cleaning and sanitizing the Form-Fill-Seal (FFS) machine to prevent cross-contamination, ensure product quality, and comply with regulatory requirements. 2) Scope This SOP applies to…
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SOP for Equipment Validation (IQ/OQ/PQ) Standard Operating Procedure for Equipment Validation (IQ/OQ/PQ) 1) Purpose The purpose of this SOP is to establish the procedures for the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of equipment used in the pharmaceutical industry to ensure they meet required specifications and regulatory standards. 2) Scope This…
SOP for Impurity Testing Standard Operating Procedure for Impurity Testing 1) Purpose This SOP outlines the procedures for conducting impurity testing on pharmaceutical raw materials and products. 2) Scope This SOP applies to impurity testing of raw materials, intermediate products, and finished pharmaceutical products in the manufacturing facility. 3) Responsibilities The Quality Control (QC) department…