The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this SOP is to outline the process for maintaining capsule appearance during packaging. Ensuring that capsules retain their appearance throughout the packaging process is crucial for maintaining product quality, appearance, and compliance with regulatory standards.
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The purpose of this SOP is to establish a standardized procedure for customizing capsule size for clinical trials. Capsule size customization is crucial in clinical trials to ensure that the dosage is appropriate for trial participants, while also complying with regulatory and quality requirements.
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The purpose of this SOP is to define the procedure for operating capsule inspection machines. These machines are used to ensure that capsules meet the required specifications for size, shape, integrity, and appearance. This SOP ensures that capsules are properly inspected and that any defective capsules are rejected before packaging.
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The purpose of this SOP is to define the process for the encapsulation of multi-layer pellets into capsules. Multi-layer pellets are used for controlled, extended, or delayed drug release, and this procedure ensures proper encapsulation to maintain product integrity, efficacy, and compliance with regulatory standards.
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The purpose of this SOP is to define the process for online weight monitoring of capsules during manufacturing. The goal is to ensure that capsules are filled with the correct amount of active ingredient and excipient, maintaining consistent quality and regulatory compliance.
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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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