The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To describe the procedure for sampling of raw materials such as APIs, excipients, and solvents in a GMP-compliant manner to ensure samples taken for analysis are representative of the entire batch or lot.
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To outline a standardized procedure for receiving, verifying, and inspecting raw materials including APIs, excipients, solvents, and other ingredients used in API manufacturing. This ensures all received materials are checked for compliance, free from damage, correctly documented, and quarantined until tested and approved.
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The purpose of this Standard Operating Procedure (SOP) is to establish a comprehensive, risk-based process for evaluating, qualifying, approving, and monitoring vendors supplying raw materials, excipients, solvents, packaging components, and critical utilities used in Active Pharmaceutical Ingredient (API) manufacturing. This SOP ensures that materials procured meet predefined quality and regulatory standards and originate from GMP-compliant sources.
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