The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Granulation Size Distribution Procedure for Granulation Size Distribution Analysis 1) Purpose The purpose of this SOP is to outline the procedure for determining the size distribution of granules used in pharmaceutical manufacturing to ensure consistency and quality in the final product. 2) Scope This SOP applies to all granulation batches prepared for tablet…
SOP for Blend Uniformity Testing Procedure for Blend Uniformity Analysis 1) Purpose The purpose of this SOP is to outline the procedure for performing blend uniformity testing to ensure the homogeneity of pharmaceutical blends prior to tablet or capsule production. 2) Scope This SOP applies to all pharmaceutical blends prepared for tablet or capsule production…
Standard Operating Procedure for Batch Sampling and Testing 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the systematic and controlled sampling and testing of batches in the pharmaceutical manufacturing process. This SOP ensures that representative samples are collected and tested for quality attributes, ensuring that the batch meets…
Standard Operating Procedure for Batch Record Review and Approval 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the systematic and thorough review and approval of batch records in the pharmaceutical manufacturing facility. This SOP ensures that each batch record is meticulously examined for accuracy, completeness, and compliance with…
Read More “Tablet Manufacturing: SOP for Batch Record Review and Approval” »
Standard Operating Procedure for Batch Release and Product Release 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the systematic and controlled process of batch release and product release in the pharmaceutical manufacturing facility. This SOP ensures that each batch of pharmaceutical products undergoes thorough review, testing, and verification…
Standard Operating Procedure for Batch Record Preparation and Documentation 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the proper preparation and documentation of batch records in the pharmaceutical manufacturing process. This SOP ensures that batch records are accurately and comprehensively documented, reflecting all critical steps, measurements, and observations…
Read More “SOP for Batch Record Preparation and Documentation” »
Standard Operating Procedure for Equipment Verification and Calibration 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the verification and calibration of equipment used in the pharmaceutical manufacturing process. This SOP ensures that all equipment is regularly checked for accuracy, precision, and compliance with required specifications to maintain the…
Read More “SOP for Equipment Verification and Calibration” »
Standard Operating Procedure for Handling and Transporting Tablets within the Department 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the safe and proper handling and transportation of tablets within the manufacturing department. This SOP aims to minimize the risk of tablet damage, contamination, and mix-up during handling and…
Read More “SOP for Handling and Transporting Tablets within the Manufacturing Department” »
Standard Operating Procedure for Inventory Control and Stock Rotation 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the effective inventory control and stock rotation of pharmaceutical products within the manufacturing facility. This SOP aims to ensure that the oldest stock is used first (first-in-first-out, FIFO), minimize product expiry,…
Standard Operating Procedure for Tablet Storage and Retrieval 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the proper storage, organization, and retrieval of tablets in the pharmaceutical manufacturing facility. This SOP ensures that tablets are stored under controlled conditions, easily accessible, and that the correct inventory is maintained…