The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for pH Determination Standard Operating Procedure for pH Determination 1) Purpose This SOP outlines the procedures for determining the pH of pharmaceutical raw materials and products. 2) Scope This SOP applies to pH determination of raw materials, intermediate products, and finished pharmaceutical products in the manufacturing facility. 3) Responsibilities The Quality Control (QC) department…
SOP for Supplier Complaint Handling Supplier Complaint Handling – Standard Operating Procedure 1) Purpose To establish guidelines for the systematic handling and resolution of supplier complaints to ensure timely investigation, effective communication, and appropriate corrective actions within the pharmaceutical purchase department. 2) Scope This SOP applies to all complaints received from internal stakeholders related to…
SOP for Moisture Content Determination Standard Operating Procedure for Moisture Content Determination 1) Purpose This SOP outlines the procedures for determining the moisture content of pharmaceutical raw materials and products. 2) Scope This SOP applies to moisture content determination of raw materials, intermediate products, and finished pharmaceutical products in the manufacturing facility. 3) Responsibilities The…
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: Injectables: SOP for Validation of FFS Machine Process” »
SOP for Friability Testing of Tablets Standard Operating Procedure for Friability Testing of Tablets 1) Purpose This SOP outlines the procedures for conducting friability testing on pharmaceutical tablets to assess their resistance to abrasion and impact. 2) Scope This SOP applies to friability testing of tablets manufactured in the pharmaceutical facility. 3) Responsibilities The Quality…
SOP for Hardness Testing of Tablets Standard Operating Procedure for Hardness Testing of Tablets 1) Purpose This SOP outlines the procedures for conducting hardness testing on pharmaceutical tablets to ensure mechanical strength and quality. 2) Scope This SOP applies to hardness testing of tablets manufactured in the pharmaceutical facility. 3) Responsibilities The Quality Control (QC)…
SOP for External Audits Standard Operating Procedure for External Audits 1) Purpose The purpose of this SOP is to define the procedure for preparing, conducting, and managing external audits conducted by regulatory authorities or external auditors to ensure compliance with regulatory requirements and quality standards. 2) Scope This SOP applies to all departments and processes…
SOP for Handling of Expired Materials Handling of Expired Materials – Standard Operating Procedure 1) Purpose To establish guidelines for the identification, segregation, handling, and disposal of expired materials to prevent their use in manufacturing processes, ensure product quality and compliance within the pharmaceutical manufacturing department. 2) Scope This SOP applies to all expired materials,…
Read More “Purchase Departments: SOP for Handling of Expired Materials” »
SOP for Disintegration Testing Standard Operating Procedure for Disintegration Testing 1) Purpose This SOP outlines the procedures for conducting disintegration testing on pharmaceutical solid oral dosage forms to assess their disintegration characteristics. 2) Scope This SOP applies to disintegration testing of tablets and capsules manufactured in the pharmaceutical facility. 3) Responsibilities The Quality Control (QC)…
SOP for Minimum and Maximum Stock Levels Minimum and Maximum Stock Levels – Standard Operating Procedure 1) Purpose To establish guidelines for setting and maintaining minimum and maximum stock levels to ensure optimal inventory management, prevent stockouts, and avoid overstocking within the pharmaceutical manufacturing department. 2) Scope This SOP applies to all inventory items, including…