The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this SOP is to establish a standardized procedure for monitoring the shape uniformity of capsules during manufacturing. Ensuring that the capsules maintain consistent shape is crucial for product quality, performance, and compliance with regulatory standards.
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The purpose of this SOP is to establish a standardized procedure for handling soft gelatin capsule leaks. Soft gelatin capsules may sometimes develop leaks due to issues such as improper sealing, material defects, or mechanical damage. This procedure ensures that leaked capsules are identified, isolated, and handled appropriately to maintain product quality and prevent contamination.
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The purpose of this SOP is to establish a standardized procedure for preparing and reviewing production reconciliation reports for capsules. These reports ensure that capsule production is accurately accounted for, identifying any discrepancies between raw materials used, production output, and finished products.
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The purpose of this SOP is to outline the procedure for coating capsules with enteric coatings. Enteric coatings are designed to protect the capsule contents from stomach acid and to ensure that the active ingredients are released in the small intestine. This process must be carried out in compliance with GMP guidelines to ensure the effectiveness, safety, and consistency of the coated capsules.
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The purpose of this SOP is to establish a standardized procedure for preparing filled capsules for the packing process. Proper preparation ensures that the capsules are correctly handled, verified, and stored in compliance with GMP guidelines before they are packed for distribution.
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The purpose of this SOP is to establish a standardized procedure for labeling capsules with lot numbers. Proper lot numbering is crucial for traceability, inventory management, and regulatory compliance, ensuring that capsules can be identified and traced throughout the manufacturing and distribution process.
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The purpose of this SOP is to outline the procedure for monitoring the thickness of capsules during the drying process. Proper monitoring ensures that capsules meet the required specifications for uniformity and quality, preventing issues such as cracking or instability during storage.
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The purpose of this SOP is to outline the procedures for cleaning capsule fill tanks between batches. Proper cleaning of the fill tanks is crucial to prevent cross-contamination and ensure the quality of the capsules produced, in compliance with GMP guidelines.
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The purpose of this SOP is to outline the procedure for conducting line clearance before starting the capsule manufacturing process. Proper line clearance ensures that the production line is free from any residual materials, tools, or foreign objects, preventing contamination and ensuring product quality.
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The purpose of this SOP is to outline the procedure for documenting capsule defects during production. Proper documentation of defects is essential to identify, address, and prevent recurring quality issues, and to ensure compliance with regulatory and internal quality standards.
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