The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Training Training – Standard Operating Procedure 1) Purpose To establish guidelines for the development, implementation, and evaluation of training programs to ensure competency and compliance within the pharmaceutical manufacturing department. 2) Scope This SOP applies to all training activities conducted for personnel involved in the manufacture, testing, and distribution of pharmaceutical products. 3)…
SOP for Document Control Document Control – Standard Operating Procedure 1) Purpose To establish guidelines for controlling the creation, review, approval, distribution, and maintenance of documents within the pharmaceutical manufacturing department. 2) Scope This SOP applies to all documents, including procedures, specifications, forms, and records, that are critical to the quality and compliance of pharmaceutical…
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SOP for Material Handling Material Handling – Standard Operating Procedure 1) Purpose To establish guidelines for the safe and efficient handling of materials within the warehouse or manufacturing environment. 2) Scope This SOP applies to all material handling activities including receipt, storage, retrieval, and distribution within the facility. 3) Responsibilities Warehouse Team: Responsible for executing…
SOP for Inventory Reconciliation Inventory Reconciliation – Standard Operating Procedure 1) Purpose To establish guidelines for reconciling physical inventory counts with inventory records to ensure accuracy and compliance within the inventory management department. 2) Scope This SOP applies to the process of reconciling inventory counts and records to maintain accurate inventory levels and comply with…
SOP for Inventory Management Inventory Management – Standard Operating Procedure 1) Purpose To establish guidelines for managing inventory levels, storage, and distribution of pharmaceutical products within the inventory management department. 2) Scope This SOP applies to all aspects of inventory management including receipt, storage, handling, distribution, and inventory control. 3) Responsibilities Inventory Management Team: Responsible…
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SOP for Supplier Relationship Management Supplier Relationship Management – Standard Operating Procedure 1) Purpose To establish guidelines for managing relationships with suppliers to ensure collaboration, continuous improvement, and mutual benefit within the pharmaceutical purchase department. 2) Scope This SOP applies to managing and enhancing supplier relationships to achieve strategic procurement goals and objectives. 3) Responsibilities…
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SOP for Supplier Qualification Supplier Qualification – Standard Operating Procedure 1) Purpose To establish guidelines for qualifying suppliers based on their capability, quality systems, and compliance with regulatory requirements within the pharmaceutical purchase department. 2) Scope This SOP applies to the process of evaluating and qualifying suppliers to ensure they meet specified criteria for procurement…
SOP for Supplier Audits Supplier Audits – Standard Operating Procedure 1) Purpose To establish guidelines for conducting supplier audits to assess compliance, quality systems, and capability within the pharmaceutical purchase department. 2) Scope This SOP applies to planning, conducting, and reporting supplier audits to ensure suppliers meet regulatory and quality requirements. 3) Responsibilities Quality Assurance…
SOP for Supplier Performance Evaluation Supplier Performance Evaluation – Standard Operating Procedure 1) Purpose To establish guidelines for evaluating supplier performance to ensure continuous improvement and alignment with quality and delivery expectations within the pharmaceutical purchase department. 2) Scope This SOP applies to evaluating and monitoring supplier performance based on defined metrics and criteria. 3)…
SOP for Supplier Corrective Action Requests Supplier Corrective Action Requests – Standard Operating Procedure 1) Purpose To establish guidelines for requesting corrective actions from suppliers to address non-conformances and improve performance within the pharmaceutical purchase department. 2) Scope This SOP applies to requesting and managing corrective actions requested from suppliers following non-conformance incidents. 3) Responsibilities…