The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Validation of FFS Machine Process Standard Operating Procedure for Validation of FFS Machine Process 1) Purpose The purpose of this SOP is to establish a procedure for validating the Form-Fill-Seal (FFS) machine process to ensure consistent and reliable packaging of pharmaceutical products. 2) Scope This SOP applies to the validation of all FFS…
Read More “Injectables: SOP for Validation of FFS Machine Process” »
SOP for Assay Testing Standard Operating Procedure for Assay Testing 1) Purpose This SOP outlines the procedures for conducting assay testing on pharmaceutical raw materials and products. 2) Scope This SOP applies to assay testing of raw materials, intermediate products, and finished pharmaceutical products in the manufacturing facility. 3) Responsibilities The Quality Control (QC) department…
SOP for Corrective Maintenance Procedures Standard Operating Procedure for Corrective Maintenance Procedures 1) Purpose The purpose of this SOP is to establish the procedures for identifying, reporting, and correcting equipment and system failures in the pharmaceutical industry to ensure minimal downtime and compliance with regulatory requirements. 2) Scope This SOP applies to all equipment and…
SOP for Purchase Order Amendments and Cancellations Purchase Order Amendments and Cancellations – Standard Operating Procedure 1) Purpose To establish guidelines for requesting, processing, and documenting amendments and cancellations to purchase orders within the pharmaceutical purchase department. 2) Scope This SOP applies to all purchase orders issued for materials, components, equipment, and services related to…
Read More “SOP for Purchase Order Amendments and Cancellations” »
SOP for Identification Tests Standard Operating Procedure for Identification Tests 1) Purpose This SOP outlines the procedures for conducting identification tests on pharmaceutical raw materials and products. 2) Scope This SOP applies to identification testing of raw materials, intermediate products, and finished pharmaceutical products in the manufacturing facility. 3) Responsibilities The Quality Control (QC) department…
SOP for Preventive Maintenance Program Standard Operating Procedure for Preventive Maintenance Program 1) Purpose The purpose of this SOP is to establish a systematic approach for the preventive maintenance of equipment and systems in the pharmaceutical industry to ensure their optimal performance, reliability, and compliance with regulatory requirements. 2) Scope This SOP applies to all…
Read More “Maintenance Dept.: SOP for Preventive Maintenance Program” »
SOP for Installation and Qualification of FFS Machine Standard Operating Procedure for Installation and Qualification of FFS Machine 1) Purpose The purpose of this SOP is to define the procedure for installing and qualifying a Form-Fill-Seal (FFS) machine to ensure it meets operational requirements and regulatory standards before use in pharmaceutical manufacturing. 2) Scope This…
Read More “SOP for Installation and Qualification of FFS Machine” »
SOP for Price Negotiation and Cost Saving Price Negotiation and Cost Saving – Standard Operating Procedure 1) Purpose To establish guidelines for conducting effective price negotiations with suppliers and implementing cost-saving initiatives within the pharmaceutical purchase department. 2) Scope This SOP applies to all procurement activities involving price negotiation, supplier agreements, and cost-saving strategies. 3)…
SOP for Specific Gravity Testing Standard Operating Procedure for Specific Gravity Testing 1) Purpose This SOP outlines the procedures for determining the specific gravity of pharmaceutical liquids or solids. 2) Scope This SOP applies to specific gravity testing of raw materials, intermediate products, and finished pharmaceutical products in the manufacturing facility. 3) Responsibilities The Quality…
SOP for Viscosity Testing Standard Operating Procedure for Viscosity Testing 1) Purpose This SOP outlines the procedures for determining the viscosity of pharmaceutical liquids or semi-solids. 2) Scope This SOP applies to viscosity testing of raw materials, intermediate products, and finished pharmaceutical products in the manufacturing facility. 3) Responsibilities The Quality Control (QC) department is…