Tag: Cleanroom standards

SOP for Cleaning Validation Standard Operating Procedure for Cleaning Validation in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to define the procedures for cleaning validation to ensure that all equipment used in the manufacturing of ocular dosage forms is cleaned effectively to prevent cross-contamination and ensure product quality and safety….

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SOP for Process Qualification Standard Operating Procedure for Process Qualification in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish the procedures for process qualification to ensure that all manufacturing processes involved in the production of ocular dosage forms consistently produce products of desired quality that meet predefined specifications and…

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SOP for Equipment Qualification Standard Operating Procedure for Equipment Qualification in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to define the procedures for equipment qualification to ensure that all manufacturing equipment used in the production of ocular dosage forms meets predetermined specifications and regulatory requirements. 2) Scope This SOP applies…

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SOP for Regulatory Compliance System Standard Operating Procedure for Regulatory Compliance System in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish a Regulatory Compliance System (RCS) to ensure that all activities related to the manufacturing, testing, and distribution of ocular dosage forms comply with applicable regulatory requirements. This SOP…

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SOP for Quality Assurance System Standard Operating Procedure for Quality Assurance System in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish a comprehensive Quality Assurance System (QAS) to ensure that all processes related to the manufacturing of ocular dosage forms, including eye drops, ointments, gels, and inserts, comply with…

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SOP for Incident Management System Standard Operating Procedure for Incident Management System in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish a structured Incident Management System (IMS) to promptly detect, assess, report, investigate, and mitigate incidents occurring during the manufacturing of ocular dosage forms, including eye drops, ointments, gels,…

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SOP for Change Management System Standard Operating Procedure for Change Management System in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish a systematic Change Management System (CMS) to ensure that changes to processes, equipment, facilities, or systems related to the manufacturing of ocular dosage forms are evaluated, controlled, and…

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SOP for Audit Management System Standard Operating Procedure for Audit Management System in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish a comprehensive Audit Management System (AMS) to ensure regular and systematic audits are conducted to verify compliance with regulatory requirements, company policies, and to identify areas for continuous…

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SOP for Training Management System Standard Operating Procedure for Training Management System in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish a Training Management System (TMS) to ensure that all employees involved in the manufacturing of ocular dosage forms are adequately trained, competent, and compliant with regulatory and company…

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SOP for Safety Management System Standard Operating Procedure for Safety Management System in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish a comprehensive Safety Management System (SMS) to ensure a safe working environment, minimize accidents, and comply with regulatory safety standards in the manufacturing of ocular dosage forms. 2)…

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