The Ultimate Resource for Pharmaceutical SOPs and Best Practices
Standard Operating Procedure for Labeling Process Purpose The purpose of this SOP is to establish procedures for the accurate and controlled labeling of pharmaceutical products, ensuring compliance with regulatory standards, and maintaining product traceability. Scope This SOP applies to all personnel involved in the labeling process, including operators, technicians, and quality control personnel. Responsibilities Operators: Responsible…
Standard Operating Procedure for Bottle Filling and Capping Process Purpose The purpose of this SOP is to establish procedures for the efficient and controlled filling and capping of bottles, ensuring accuracy, quality, and compliance with regulatory standards. Scope This SOP applies to all personnel involved in the bottle filling and capping process, including operators, technicians, and…
Standard Operating Procedure for Data Validation and Verification Purpose The purpose of this SOP is to establish procedures for the systematic validation and verification of electronic data within the pharmaceutical manufacturing facility. This ensures the accuracy, reliability, and integrity of data used for decision-making and regulatory compliance. Scope This SOP applies to all personnel involved…
Standard Operating Procedure for Blister Packaging Process Purpose The purpose of this SOP is to establish procedures for the blister packaging of pharmaceutical products, ensuring the packaging process is consistent, meets quality standards, and complies with regulatory requirements. Scope This SOP applies to all personnel involved in the blister packaging process, including operators, technicians, and quality…
Standard Operating Procedure for Data Security and Access Control Purpose The purpose of this SOP is to establish procedures for ensuring the security of electronic data and controlling access to sensitive information within the pharmaceutical manufacturing facility. This ensures data integrity, confidentiality, and compliance with regulatory requirements. Scope This SOP applies to all personnel involved in…
Standard Operating Procedure for Sifting and Sieving Process Purpose The purpose of this SOP is to establish procedures for the effective sifting and sieving of materials, ensuring particle size consistency, quality, and compliance with regulatory standards. Scope This SOP applies to all personnel involved in the sifting and sieving process, including operators, technicians, and quality…
Standard Operating Procedure for Data Migration Purpose The purpose of this SOP is to establish procedures for the controlled migration of electronic data from one system or platform to another within the pharmaceutical manufacturing facility. This ensures data integrity, accuracy, and compliance with regulatory requirements. Scope This SOP applies to all personnel involved in the generation,…
Standard Operating Procedure for Drying Process Purpose The purpose of this SOP is to establish procedures for the effective and controlled drying of materials, ensuring consistency, quality, and compliance with regulatory standards. Scope This SOP applies to all personnel involved in the drying process, including operators, technicians, and quality control personnel. Responsibilities Operators: Responsible for executing…
Standard Operating Procedure for Capsule Polishing Purpose The purpose of this SOP is to establish procedures for the polishing of capsules, ensuring the removal of any surface imperfections, dust, or loose particles to meet quality standards. Scope This SOP applies to all personnel involved in the capsule polishing process, including operators, quality control personnel, and…
Standard Operating Procedure for Data Backup and Restoration Purpose The purpose of this SOP is to establish procedures for the routine backup of electronic data and the systematic restoration of data in the event of data loss or system failure. This ensures data integrity, continuity, and compliance with regulatory requirements. Scope This SOP applies to…