The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To describe the standard procedure for preparing Thin Layer Chromatography (TLC) plates and interpreting results during in-process checks, reaction monitoring, and identification of raw materials or intermediates in API manufacturing.
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To define the standard procedure for monitoring and controlling pH during reaction stages in API manufacturing to ensure reaction efficiency, reproducibility, and product quality as per the validated process parameters.
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To outline a standardized technique for in-process sampling during API manufacturing that ensures representative sampling for critical quality attributes and compliance with cGMP and regulatory requirements.
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To establish a standardized procedure for the recording, review, and control of drying and milling logs to ensure complete traceability of product processing, compliance with cGMP guidelines, and data integrity.
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To define the procedure for the operation of vibratory sifters in API manufacturing for ensuring particle uniformity, removal of oversized materials, and compliance with GMP standards.
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To define the standard procedure for screening of final Active Pharmaceutical Ingredient (API) powder before sampling, analysis, and packing, ensuring uniformity in particle size and elimination of foreign matter or lumps.
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To define the standard procedure for conducting equipment line clearance before initiating drying operations to ensure cleanliness, prevent cross-contamination, and maintain GMP compliance.
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To establish a standard procedure for preventing and managing electrostatic charge generation during milling operations in API manufacturing, ensuring safety of personnel, equipment, and product integrity.
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To establish a standard cleaning procedure for milling equipment such as jet mills, pin mills, hammer mills, and impact mills used in API manufacturing, to prevent product cross-contamination and maintain GMP compliance.
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To define the procedure for preventing cross contamination during drying processes of Active Pharmaceutical Ingredients (APIs) in the manufacturing facility, ensuring compliance with cGMP and product quality.
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