The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this SOP is to establish a standardized procedure for preparing Batch Manufacturing Records (BMRs) for capsule production. The BMR ensures that all manufacturing processes are documented, compliant with GMP, and traceable.
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The purpose of this SOP is to define the procedure for sampling capsules during stability testing. This ensures representative samples are taken for testing at predefined intervals to assess the stability and quality of the capsules.
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The purpose of this SOP is to define the procedure for monitoring and maintaining stability chambers used in stability testing for capsules. Proper chamber maintenance and monitoring are critical for ensuring accurate and reliable results for stability studies.
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The purpose of this SOP is to define the procedure for conducting photostability testing on capsules. Photostability testing assesses the stability of capsules when exposed to light to ensure their efficacy and safety under typical storage conditions.
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The purpose of this SOP is to define the procedure for conducting accelerated stability testing on capsules to evaluate their stability under accelerated conditions. This testing helps predict the long-term shelf-life and potential degradation of capsules under accelerated environmental conditions.
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The purpose of this SOP is to define the procedure for conducting long-term stability studies for capsules. These studies are crucial for assessing the shelf-life, potency, and quality of capsules over time under specified storage conditions.
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The purpose of this SOP is to provide guidelines for the proper handling and storage of packed capsules to maintain product integrity, ensure quality, and prevent contamination or damage during storage or transportation.
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The purpose of this SOP is to define the process for cartoning capsules for distribution. It ensures the capsules are securely packed in cartons, appropriately labeled, and ready for transportation in compliance with regulatory and GMP standards.
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The purpose of this SOP is to establish a standard procedure for monitoring the packaging line speeds during capsule packaging. Ensuring that the line speed is properly set and maintained is crucial for ensuring product quality, avoiding defects, and optimizing production efficiency.
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This SOP defines the procedure for packing capsules into aluminum foil to ensure product integrity, compliance with regulatory standards, and protection from moisture, light, and contaminants during storage and distribution.
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