The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To establish a procedure for monitoring and documenting environmental conditions such as temperature, relative humidity, pest control, and cleanliness in API warehouse areas to ensure storage conditions comply with GMP requirements and maintain product quality.
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To lay down the procedure for effective cleaning, drying, labeling, and maintenance of containers used for storage and transfer of raw materials in API manufacturing, to prevent cross-contamination and ensure material integrity.
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To describe the systematic procedure for identification, segregation, recording, evaluation, and disposal of expired raw materials in order to prevent their unintentional use in production and ensure GMP compliance in API manufacturing.
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To define the procedure for safe handling and storage of hazardous and flammable materials used in API manufacturing to minimize risks of fire, explosion, chemical exposure, and ensure compliance with GMP, GHS, and safety regulations.
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To describe the procedure for implementing FIFO (First In First Out) and FEFO (First Expiry First Out) material handling principles in the warehouse to ensure proper rotation of raw materials, minimize expiry-related losses, and comply with cGMP requirements.
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To describe the systematic procedure for reconciling the quantity of raw materials issued to production and the quantity of unused materials returned to the warehouse, ensuring material accountability, inventory accuracy, and GMP compliance.
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To establish a standardized procedure for the implementation and use of a barcode system for the labeling, tracking, and inventory control of raw materials in the API manufacturing warehouse. This enhances traceability, reduces manual errors, and improves GMP compliance.
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To define the standardized procedure for the controlled issuance of raw materials from warehouse to production area for manufacturing of Active Pharmaceutical Ingredients (API), ensuring traceability, GMP compliance, and prevention of cross-contamination or mix-ups.
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To describe the procedure for receiving, storing, monitoring, and handling temperature-sensitive raw materials such as APIs, excipients, and solvents that require specific temperature conditions to maintain their quality and stability in the API manufacturing warehouse.
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To define the standard method for labeling raw material containers using color-coded status tags (Quarantine, Sampled, Approved, Rejected) to ensure proper identification, traceability, and compliance with GMP during the receipt, testing, and disposition stages in API manufacturing.
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