The Ultimate Resource for Pharmaceutical SOPs and Best Practices
Standard Operating Procedure for Destruction of Expired or Rejected Products Purpose The purpose of this SOP is to establish procedures for the safe and compliant destruction of expired or rejected pharmaceutical products within the distribution facility, ensuring proper disposal to prevent unauthorized use or resale. Scope This SOP applies to all personnel involved in the…
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Standard Operating Procedure for Product Authentication Purpose The purpose of this SOP is to establish procedures for the authentication of pharmaceutical products within the distribution facility, ensuring that products are genuine, safe, and compliant with regulatory requirements. Scope This SOP applies to all personnel involved in the receipt, storage, handling, and distribution of pharmaceutical products,…
Standard Operating Procedure for Product Serialization and Track & Trace Purpose The purpose of this SOP is to establish procedures for the implementation and management of product serialization and track & trace systems within the pharmaceutical distribution facility, ensuring compliance with regulatory requirements and enhancing supply chain visibility and security. Scope This SOP applies to…
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Standard Operating Procedure for Subcontractor Management Purpose The purpose of this SOP is to establish procedures for the selection, qualification, and oversight of subcontractors within the pharmaceutical distribution facility, ensuring that subcontracted activities are conducted in compliance with regulatory requirements and meet quality standards. Scope This SOP applies to all personnel involved in the selection,…
Standard Operating Procedure for Internal Audits and Self-Inspections Purpose The purpose of this SOP is to establish procedures for conducting internal audits and self-inspections within the pharmaceutical distribution facility, ensuring compliance with regulatory requirements, identifying areas for improvement, and maintaining quality standards. Scope This SOP applies to all personnel involved in the planning, execution, and…
Standard Operating Procedure for Distribution Records Management Purpose The purpose of this SOP is to establish procedures for the management and maintenance of distribution records within the pharmaceutical distribution facility, ensuring compliance with regulatory requirements and facilitating traceability and accountability throughout the distribution process. Scope This SOP applies to all personnel involved in the creation,…
Standard Operating Procedure for Transportation Validation Purpose The purpose of this SOP is to establish procedures for the validation of transportation processes for pharmaceutical products, ensuring that products are transported under controlled conditions that maintain their quality, safety, and efficacy. Scope This SOP applies to all personnel involved in the planning, execution, and oversight of…
Standard Operating Procedure for Goods Reconciliation Purpose The purpose of this SOP is to establish procedures for conducting goods reconciliation within the pharmaceutical distribution facility, ensuring accurate inventory management and compliance with regulatory requirements. Scope This SOP applies to all personnel involved in the receipt, storage, handling, and distribution of pharmaceutical products within the facility,…
Standard Operating Procedure for Management of Quarantine Areas Purpose The purpose of this SOP is to establish procedures for the effective management and control of quarantine areas within the pharmaceutical distribution facility, ensuring proper handling of products under quarantine status and preventing their unauthorized release into distribution. Scope This SOP applies to all personnel involved…
Standard Operating Procedure for Handling of Counterfeit Products Purpose The purpose of this SOP is to establish procedures for the identification, quarantine, and reporting of counterfeit products within the pharmaceutical distribution facility, ensuring compliance with regulatory requirements and safeguarding patient safety and product integrity. Scope This SOP applies to all personnel involved in the receipt,…