The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this SOP is to establish procedures for the validation of manufacturing processes to ensure consistency & reliability of Manufacturing Processes.
2) Scope
This SOP applies to all manufacturing processes within the facility that impact product quality, including but not limited to, formulation, filling, packaging, and cleaning processes.
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The purpose of this SOP is to establish procedures for the development, implementation, and management of a training program to ensure that personnel are competent, qualified, and compliant with job responsibilities within the manufacturing facility.
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The purpose of this SOP is to establish procedures for the initiation, review, approval, implementation, and closure of change controls to ensure controlled and systematic change management within the manufacturing facility.
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The purpose of this SOP is to establish procedures for the identification, investigation, and handling of out-of-specification (OOS) results to ensure product quality, data integrity, and compliance with regulatory requirements.
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The purpose of this SOP is to establish procedures for the prevention, detection, and elimination of pests within the manufacturing facility to ensure product safety, quality, and compliance with regulatory requirements.
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The purpose of this SOP is to establish procedures for the effective and efficient changeover of equipment and processes to minimize downtime, reduce product variability, and ensure compliance with regulatory requirements.
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The purpose of this SOP is to establish procedures for the training, competency assessment, and qualification of personnel to ensure competence in performing assigned tasks and responsibilities.
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The purpose of this SOP is to establish procedures for the receipt, evaluation, handling, and disposition of returned goods to ensure compliance with regulatory requirements and customer satisfaction.
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The purpose of this SOP is to establish procedures for the receipt, evaluation, investigation, and resolution of product complaints to ensure customer satisfaction and compliance with regulatory requirements.
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The purpose of this SOP is to establish procedures for the control, documentation, and implementation of changes to facilities, systems, equipment, processes, and documents to ensure product quality, safety, and efficacy.
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