The Ultimate Resource for Pharmaceutical SOPs and Best Practices
This Standard Operating Procedure (SOP) defines the process for the initial inspection of water-sensitive raw materials upon receipt at the facility. Proper inspection ensures that materials susceptible to moisture degradation maintain their quality and integrity, preventing contamination, loss of potency, and compromised manufacturing outcomes. The SOP outlines procedures to:
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This Standard Operating Procedure (SOP) defines the process for identifying, documenting, and addressing temperature deviations in materials received at the facility. Temperature-sensitive raw materials, such as pharmaceuticals, chemicals, and biologics, require strict temperature control to maintain their efficacy, stability, and compliance with regulatory standards. The objectives of this SOP are to:
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This Standard Operating Procedure (SOP) establishes the guidelines for the safe receipt, inspection, and handling of Highly Potent Raw Materials (HPRMs) at the facility. HPRMs, due to their toxicological properties, require specialized handling procedures to protect personnel, maintain material integrity, and comply with Good Manufacturing Practices (GMP) and regulatory standards. This SOP ensures:
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This Standard Operating Procedure (SOP) establishes the guidelines for systematic documentation and record-keeping of all raw materials received at the facility. Proper documentation ensures traceability, accountability, and compliance with Good Manufacturing Practices (GMP) and regulatory requirements. This SOP outlines:
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This Standard Operating Procedure (SOP) defines the process for the safe and compliant receipt of raw materials that require special handling instructions. These materials may include hazardous chemicals, temperature-sensitive items, moisture-sensitive products, and materials with unique storage or safety requirements. This SOP ensures:
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This Standard Operating Procedure (SOP) outlines the process for effective coordination between the Procurement Department and the Warehouse, Quality Assurance (QA), and Quality Control (QC) teams during the receipt of raw materials. Clear communication and collaboration between these departments ensure that raw materials are received, inspected, and documented accurately, in compliance with Good Manufacturing Practices (GMP) and regulatory requirements. This SOP aims to:
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This Standard Operating Procedure (SOP) outlines the process for ensuring that all raw materials received at the facility comply with transportation and delivery requirements. Proper adherence to transportation SOPs is essential to maintain material integrity, ensure regulatory compliance, and uphold Good Distribution Practices (GDP). This SOP aims to:
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This Standard Operating Procedure (SOP) defines the process for identifying, documenting, and reporting deviations during the receipt of raw materials. Deviations can occur due to discrepancies in quantity, packaging, labeling, transportation conditions, or non-conformance with supplier documentation. This SOP ensures:
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This Standard Operating Procedure (SOP) defines the safe and compliant process for handling and unpacking large bulk material containers received at the facility. Large bulk containers, such as drums, totes, and IBCs (Intermediate Bulk Containers), require specific handling procedures to prevent contamination, damage, or injury. This SOP ensures:
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This Standard Operating Procedure (SOP) outlines the process for cross-verifying vendor details during the receipt of raw materials. Ensuring that vendor information is accurate and consistent across purchase orders, delivery documents, and material receipt logs is critical for maintaining supply chain integrity and regulatory compliance. This SOP ensures:
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