Tag: Capsule Batch Record

SOP for Calibration and Maintenance: Procedures for Calibrating and Maintaining Equipment Calibration and Maintenance Procedures 1) Purpose The purpose of this SOP is to establish standardized procedures for calibrating and maintaining equipment to ensure accurate and reliable performance. 2) Scope This SOP applies to all equipment used in the pharmaceutical manufacturing facility that requires calibration…

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SOP for Document Control: Procedures for Managing the Creation, Approval, Distribution, and Archiving of Documents Document Control Procedures 1) Purpose The purpose of this SOP is to establish standardized procedures for managing the creation, approval, distribution, and archiving of documents to ensure accurate and up-to-date documentation within the pharmaceutical manufacturing facility. 2) Scope This SOP…

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SOP for Cleaning and Sanitation: Procedures for Cleaning and Sanitizing Equipment and Facilities Cleaning and Sanitation Procedures 1) Purpose The purpose of this SOP is to establish standardized procedures for cleaning and sanitizing equipment and facilities to ensure a hygienic manufacturing environment and prevent contamination. 2) Scope This SOP applies to all equipment and facilities…

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SOP for Change Control: Procedures for Managing Changes to Processes, Equipment, or Procedures Change Control Procedures 1) Purpose The purpose of this SOP is to establish standardized procedures for managing changes to processes, equipment, or procedures to ensure that all changes are properly evaluated, documented, and implemented without negatively impacting product quality. 2) Scope This…

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SOP for Employee Training: Procedures for Training Employees on Manufacturing Processes, Safety Protocols, and Quality Standards Employee Training Procedures 1) Purpose The purpose of this SOP is to establish standardized procedures for training employees on manufacturing processes, safety protocols, and quality standards to ensure competence and compliance. 2) Scope This SOP applies to all employees…

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SOP for Auditing Suppliers: Procedures for Auditing and Qualifying Suppliers of Raw Materials and Components Supplier Auditing and Qualification Procedures 1) Purpose The purpose of this SOP is to establish standardized procedures for auditing and qualifying suppliers of raw materials and components to ensure they meet specified quality standards and regulatory requirements. 2) Scope This…

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SOP for Environmental Monitoring: Procedures for Monitoring and Controlling the Manufacturing Environment Environmental Monitoring Procedures 1) Purpose The purpose of this SOP is to establish standardized procedures for monitoring and controlling the manufacturing environment to ensure it meets specified quality standards. 2) Scope This SOP applies to all areas within the pharmaceutical manufacturing facility where…

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SOP for Recall Procedures: Procedures for Recalling Defective or Non-Compliant Products from the Market Recall Procedures for Defective or Non-Compliant Products 1) Purpose The purpose of this SOP is to establish a standardized procedure for recalling defective or non-compliant products from the market to ensure consumer safety and compliance with regulatory requirements. 2) Scope This…

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SOP for Handling Deviations: Procedures for Identifying, Documenting, Investigating, and Resolving Deviations from Standard Procedures Deviation Handling Procedures 1) Purpose The purpose of this SOP is to establish a standardized procedure for identifying, documenting, investigating, and resolving deviations from standard procedures in the pharmaceutical manufacturing process. 2) Scope This SOP applies to all deviations from…

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SOP for Handling Customer Complaints: Procedures for Logging, Investigating, and Resolving Customer Complaints Related to Capsule Quality Customer Complaint Handling Procedures 1) Purpose The purpose of this SOP is to establish a standardized procedure for logging, investigating, and resolving customer complaints related to the quality of capsules. 2) Scope This SOP applies to all customer…

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