The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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…
Standard Operating Procedure for Capsule Inspection Purpose The purpose of this SOP is to establish procedures for the visual inspection and quality control of capsules, ensuring adherence to quality standards, and the identification of defects or deviations. Scope This SOP applies to all personnel involved in the capsule inspection process, including inspectors, quality control personnel,…
Standard Operating Procedure for Electronic Signature and Electronic Record Purpose The purpose of this SOP is to establish procedures for the use of electronic signatures and the management of electronic records within the pharmaceutical manufacturing facility. This ensures compliance with regulatory guidelines, data integrity, and traceability. Scope This SOP applies to all personnel involved in…
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Standard Operating Procedure for Operation of Drying Ovens Purpose The purpose of this SOP is to establish procedures for the safe and effective operation of drying ovens, ensuring consistent and controlled drying of materials while adhering to quality and safety standards. Scope This SOP applies to all personnel involved in the operation of drying ovens, including…
Standard Operating Procedure for Data Integrity in Laboratory Information Management System Purpose The purpose of this SOP is to establish procedures for ensuring data integrity within the Laboratory Information Management System (LIMS) to support accurate and reliable laboratory testing and compliance with regulatory requirements. Scope This SOP applies to all personnel involved in the use, administration,…
Standard Operating Procedure for Data Retention and Archiving Purpose The purpose of this SOP is to establish procedures for the systematic retention and secure archiving of electronic and paper-based data within the pharmaceutical manufacturing facility. This ensures compliance with regulatory standards and supports data integrity. Scope This SOP applies to all personnel involved in the…
Standard Operating Procedure for Audit Trail Review Purpose The purpose of this SOP is to establish procedures for the periodic review and verification of audit trails within the pharmaceutical manufacturing facility. The audit trail review ensures data integrity and compliance with regulatory requirements. Scope This SOP applies to all personnel involved in the manufacturing, quality control,…
Standard Operating Procedure for Deviation and Corrective Action Purpose The purpose of this SOP is to establish procedures for the identification, documentation, investigation, and resolution of deviations from established processes or procedures within the pharmaceutical manufacturing facility. Additionally, it outlines the steps for implementing corrective actions to prevent recurrence. Scope This SOP applies to all personnel…