The Ultimate Resource for Pharmaceutical SOPs and Best Practices
This is a comprehensive list of Standard Operating Procedures (SOPs) specifically tailored for the Quality Control Department within the pharmaceutical industry. Quality control is a critical component of the pharmaceutical manufacturing process, ensuring that every product meets rigorous standards for safety, efficacy, and compliance. These SOPs cover a wide range of quality control activities, including sampling, testing, documentation, equipment calibration, data integrity, and deviation management. Each SOP has been meticulously developed to align with international regulatory requirements and industry best practices. By following these SOPs diligently, your Quality Control Department can enhance operational efficiency, mitigate risks, and uphold the highest standards of product quality in the pharmaceutical industry.
Here is a list of SOPs related to Quality Control Department:
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 Handling and Maintenance of Disintegration Testing Equipment Purpose The purpose of this SOP is to provide comprehensive guidelines for the proper handling and maintenance of disintegration testing equipment in pharmaceutical manufacturing. Proper handling and regular maintenance of the equipment are essential to ensure accurate and reliable disintegration test results, contributing to…
Read More “SOP for Handling and Maintenance of Disintegration Testing Equipment” »
Standard Operating Procedure for Calibration & Verification of Disintegration Tester Purpose The purpose of this SOP is to establish comprehensive guidelines for the calibration and verification of the disintegration tester in pharmaceutical manufacturing. Calibration and verification ensure the accuracy and reliability of disintegration test results, leading to confident decisions on product quality and adherence to…
Read More “SOP for Calibration and Verification of Disintegration Tester:” »
Standard Operating Procedure for Tablet Disintegration Test Purpose The purpose of this SOP is to provide detailed guidelines for conducting tablet disintegration testing in pharmaceutical manufacturing. Disintegration testing is a critical quality control parameter that assesses the time it takes for tablets to disintegrate into smaller particles in simulated gastrointestinal fluids. This SOP aims to…
Read More “Quality Control, Tablet Manufacturing: SOP for Tablet Disintegration Testing:” »
Standard Operating Procedure for Operation of Tablet Disintegration Tester Purpose The purpose of this SOP is to provide detailed guidelines for the proper operation of the tablet disintegration tester in pharmaceutical manufacturing. Disintegration testing is a critical quality control test that evaluates the time it takes for tablets to disintegrate into smaller particles in simulated…
Read More “SOP for Operation of Tablet Disintegration Tester” »
Standard Operating Procedure for Handling and Maintenance of Friability Testing Equipment Purpose The purpose of this SOP is to provide comprehensive guidelines for the proper handling and maintenance of friability testing equipment in pharmaceutical manufacturing. Proper handling and regular maintenance of the equipment are essential to ensure accurate and reliable friability test results, contributing to…
Read More “SOP for Handling and Maintenance of Friability Testing Equipment” »
Standard Operating Procedure for Calibration and Verification of Friability Tester Purpose The purpose of this SOP is to establish comprehensive guidelines for the calibration and verification of the friability tester in pharmaceutical manufacturing. Calibration and verification ensure the accuracy and reliability of friability test results, leading to confident decisions on product quality and adherence to…
Read More “SOP for Calibration and Verification of Friability Tester” »
Standard Operating Procedure for Tablet Friability Testing Purpose The purpose of this SOP is to provide detailed guidelines for conducting tablet friability testing in pharmaceutical manufacturing. Friability testing is a critical quality control parameter that assesses the ability of tablets to withstand abrasion and impacts during handling and transportation. This SOP ensures accurate and consistent…
Read More “Quality Control, Tablet Manufacturing: SOP for Tablet Friability Testing” »
Standard Operating Procedure (SOP): Operation of BOD Incubator Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the safe and efficient operation of a Biological Oxygen Demand (BOD) incubator in a laboratory setting. The BOD incubator is used to maintain controlled environmental conditions for incubation of samples to measure oxygen…
Standard Operating Procedure (SOP): Operation of Hot Water Bath Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the safe and effective operation of a hot water bath in a laboratory setting. The hot water bath is used for various applications such as sample heating, thawing, and maintaining constant temperature…