The Ultimate Resource for Pharmaceutical SOPs and Best Practices
This Standard Operating Procedure (SOP) establishes a clear method for identifying and managing raw materials suspected of being counterfeit or adulterated. Counterfeit and adulterated materials pose serious threats to product quality, patient safety, and regulatory compliance. By implementing this SOP, the organization ensures:
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This Standard Operating Procedure (SOP) details the method for receiving raw materials of the same Active Pharmaceutical Ingredient (API) from multiple manufacturers. Different manufacturers may present variations in packaging, labeling, or quality attributes, making it crucial to maintain stringent checks. By following this SOP, the organization ensures:
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This Standard Operating Procedure (SOP) establishes a systematic method for receiving and handling raw materials that arrive in drums, bags, or carboys. Such packaging formats are widely used for a variety of raw materials, including powders, granules, liquids, and semi-solids. By following this SOP, the organization ensures compliance with Good Manufacturing Practice (GMP) and internal quality standards through:
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The purpose of this Standard Operating Procedure (SOP) is to establish a clear and systematic approach for conducting risk assessments on newly procured raw materials. As the pharmaceutical or life-science industry frequently onboards new raw materials from different suppliers, it is crucial to evaluate any potential risks they pose to product quality, regulatory compliance, and patient safety. These risk assessments help the organization:
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This Standard Operating Procedure (SOP) outlines a structured process for handling raw materials that are rejected during the receipt process. Rejection may occur due to material damage, non-compliance with purchase orders (POs), labeling errors, poor quality test results, or suspected adulteration. By following this SOP, the organization:
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This Standard Operating Procedure (SOP) describes a structured method for storing newly received raw materials in a designated holding area prior to formal quarantine. In many pharmaceutical or life science facilities, the holding area serves as a preliminary staging location where materials undergo basic verification before being moved into official quarantine. By following this SOP, the organization:
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This Standard Operating Procedure (SOP) outlines the standardized process for inspecting and receiving Active Pharmaceutical Ingredients (APIs), excipients, and additives upon arrival at the facility. These materials are critical to product quality and patient safety, requiring thorough checks to ensure they meet purchase order (PO) details and Good Manufacturing Practice (GMP) requirements. By following this SOP, the organization:
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This Standard Operating Procedure (SOP) defines a clear and consistent method for verifying the seal integrity of raw material drums and containers during receiving and initial inspection. Properly sealed containers are crucial in preventing contamination, maintaining the potency of active and inactive substances, and preserving product stability. By carefully checking seal integrity upon arrival, the organization:
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This Standard Operating Procedure (SOP) outlines the procedures for the inspection and acceptance of recycled or reprocessed raw materials upon receipt. Given the inherent risks associated with the reuse of materials, this SOP ensures that all recycled or reprocessed materials meet stringent quality and safety standards before being integrated into manufacturing processes. By implementing this SOP, the organization aims to:
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This Standard Operating Procedure (SOP) outlines the process for verifying vendor compliance before accepting raw materials into the facility. It ensures that all suppliers meet the required regulatory, quality, and safety standards prior to their materials being used in production. This verification process minimizes the risk of non-conforming materials, enhances product quality, and ensures compliance with Good Manufacturing Practices (GMP) and regulatory guidelines.
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