The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Sampling and Testing Guidelines for Representative Sampling and Testing 1) Purpose The purpose of this SOP is to outline the standardized procedures for taking representative samples of materials and products for testing and analysis to ensure their quality and compliance with specifications. 2) Scope This SOP applies to all raw materials, in-process materials,…
SOP for Quality Control Testing: Specific Procedures for Testing Capsules Using Analytical Instruments 1) SOP for Quality Control Testing 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide specific procedures for conducting quality control testing of capsules using analytical instruments such as HPLC (High-Performance Liquid Chromatography), spectrophotometers, and dissolution testers. 3)…
SOP for Environmental Monitoring: Guidelines for Monitoring and Recording Environmental Conditions in the Manufacturing Area 1) SOP for Environmental Monitoring 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for monitoring and recording environmental conditions in the manufacturing area to ensure compliance with regulatory requirements and maintain product quality….
SOP for Handling of Deviations and Incidents: Procedures for Identifying, Documenting, and Investigating Deviations, Incidents, or Non-Conformances 1) SOP for Handling of Deviations and Incidents 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines and procedures for identifying, documenting, investigating, and resolving deviations, incidents, or non-conformances that occur during the…
SOP for Blister Packaging: Procedures for Setting Up and Operating Blister Packaging Machines, Including Packaging Material Handling 1) SOP for Blister Packaging 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the setup and operation of blister packaging machines to ensure consistent and compliant packaging of pharmaceutical products. 3)…
SOP for Annual Product Review (APR): Procedures for Conducting an Annual Review of Product Quality and Consistency, Including Trending and Reporting 1) SOP for Annual Product Review (APR) 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for conducting an Annual Product Review (APR) to assess product quality, consistency,…
SOP for Batch Documentation Retention: Standards for Retaining Batch Documentation and Records for the Required Period 1) SOP for Batch Documentation Retention 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish standards for retaining batch documentation and records for the required period to ensure traceability, regulatory compliance, and support for quality…
SOP for CAPA (Corrective and Preventive Actions): Steps for Initiating, Documenting, and Implementing Corrective and Preventive Actions in Response to Quality Issues or Non-compliances 1) SOP for CAPA (Corrective and Preventive Actions) 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for identifying, documenting, and implementing corrective and…
SOP for Vendor Qualification and Audit: Procedures for Assessing and Qualifying Suppliers and Conducting Supplier Audits 1) SOP for Vendor Qualification and Audit 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish procedures for assessing and qualifying suppliers, as well as conducting regular supplier audits to ensure compliance with quality standards…
SOP for Waste Management: Guidelines for Proper Disposal of Waste Materials Generated During the Manufacturing Process, Including Hazardous Waste if Applicable 1) SOP for Waste Management 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the proper disposal of waste materials generated during the manufacturing process, including hazardous waste,…