SOPs for Good Distribution Practice

Standard Operating Procedure for Calibration and Maintenance of Monitoring Devices Purpose The purpose of this SOP is to establish procedures for the calibration and maintenance of monitoring devices used for temperature and humidity monitoring in pharmaceutical storage areas, ensuring accuracy and reliability in compliance with Good Distribution Practice (GDP) guidelines. Scope This SOP applies to…

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Standard Operating Procedure for Temperature Mapping and Monitoring Purpose The purpose of this SOP is to establish procedures for conducting temperature mapping studies and monitoring temperature conditions in storage areas to ensure compliance with Good Distribution Practice (GDP) guidelines and maintain product quality. Scope This SOP applies to all personnel involved in the planning, execution,…

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Standard Operating Procedure for Cold Chain Management Purpose The purpose of this SOP is to establish procedures for the effective management of the cold chain, ensuring the safe storage, handling, and distribution of temperature-sensitive pharmaceutical products in compliance with Good Distribution Practice (GDP) guidelines. Scope This SOP applies to all personnel involved in the storage,…

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Standard Operating Procedure for Storage Conditions Monitoring Purpose The purpose of this SOP is to establish procedures for the monitoring and control of storage conditions for pharmaceutical products to ensure compliance with Good Distribution Practice (GDP) guidelines and maintain product quality and integrity. Scope This SOP applies to all personnel involved in the storage and…

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Standard Operating Procedure for Receiving and Acceptance of Goods Purpose The purpose of this SOP is to establish procedures for the systematic and accurate receipt and acceptance of pharmaceutical goods, ensuring compliance with Good Distribution Practice (GDP) guidelines. Scope This SOP applies to all personnel involved in the receiving, inspection, and acceptance of pharmaceutical goods…

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Standard Operating Procedure for QMS Implementation Purpose The purpose of this SOP is to establish guidelines for the effective implementation of the Quality Management System (QMS) in accordance with Good Distribution Practice (GDP) guidelines in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the distribution and handling of pharmaceutical products within…

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Standard Operating Procedure for Transportation Management Purpose The purpose of this SOP is to establish procedures for the safe, efficient, and compliant transportation of pharmaceutical products, in accordance with Good Distribution Practice (GDP) guidelines. Scope This SOP applies to all personnel involved in the planning, execution, and monitoring of transportation activities for pharmaceutical products. Responsibilities…

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Standard Operating Procedure for Supplier Qualification and Management Purpose The purpose of this SOP is to establish procedures for the qualification, evaluation, and ongoing management of suppliers to ensure the procurement of quality materials and services in compliance with Good Distribution Practice (GDP) guidelines. Scope This SOP applies to all personnel involved in the selection,…

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Standard Operating Procedure for Complaint Handling Purpose The purpose of this SOP is to establish procedures for the systematic and effective handling of complaints related to pharmaceutical products, ensuring timely investigation, resolution, and appropriate corrective actions, in compliance with Good Distribution Practice (GDP) guidelines. Scope This SOP applies to all personnel involved in the receipt,…

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Standard Operating Procedure for Product Recall and Market Withdrawal Purpose The purpose of this SOP is to establish procedures for the prompt and effective recall or market withdrawal of pharmaceutical products in the event of quality issues or safety concerns, in compliance with Good Distribution Practice (GDP) guidelines. Scope This SOP applies to all personnel…

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