Author: Auditor

Standard Operating Procedure (SOP) for Environmental Monitoring

Standard Operating Procedure (SOP) for Environmental Monitoring 1.0 Purpose: The purpose of this SOP is to provide guidelines for performing environmental monitoring in a laboratory setting. 2.0 Scope: This SOP applies to all personnel involved in performing environmental monitoring in the laboratory. 3.0 Responsibilities: The laboratory personnel responsible for performing environmental monitoring shall: Ensure that…

Microbiology Testing

SOP for Standard Operating Procedure (SOP) for Sterility T…

Standard Operating Procedure (SOP) for Sterility Testing 1.0 Purpose: The purpose of this SOP is to provide guidelines for performing sterility testing in a laboratory setting. 2.0 Scope: This SOP applies to all personnel involved in performing sterility testing in the laboratory. 3.0 Responsibilities: The laboratory personnel responsible for performing sterility testing shall: Ensure that…

Microbiology Testing

SOP for Quality Assurance Department

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Quality assurance is a critical component of the pharmaceutical industry, as it ensures that products meet the required quality standards and comply with regulatory requirements. Quality assurance includes a range of activities, such as document control, change control, deviation management, CAPA management, vendor qualification, and audit management. Here is a list of SOPs related to…

Quality Assurance

SOP for Chemical analysis

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Chemical analysis as per pharmacopoeia involves the use of standardized methods and procedures to determine the identity, purity, and potency of pharmaceutical substances and products. The pharmacopoeia sets forth specific tests and specifications to ensure that pharmaceutical products meet the required quality standards. Chemical analysis plays a critical role in pharmaceutical manufacturing and quality control….

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Quality Assurance