The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this SOP is to define the procedure for handling capsule fines generated during manufacturing. Proper handling and disposal of capsule fines are essential to maintain product quality, prevent cross-contamination, and comply with regulatory requirements.
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The purpose of this SOP is to describe the procedures for the encapsulation of modified-release (MR) fill materials into capsules. The objective is to ensure that the MR capsules are manufactured with consistent release profiles and meet the required quality and regulatory specifications.
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The purpose of this SOP is to define the process for optimizing the granulation process in the manufacturing of hard gelatin capsules. Optimizing granulation is essential for ensuring uniformity, stability, and flow properties of the capsule fill material, which are crucial for product quality and efficiency.
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The purpose of this SOP is to describe the procedure for polishing capsules during the manufacturing process. Capsule polishing enhances the appearance of capsules, removes any dust or residues, and ensures smooth, shiny, and uniform capsules for final packaging.
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The purpose of this SOP is to define the procedure for allocating and tracking batch numbers for capsules produced during manufacturing. A systematic approach to batch number allocation ensures traceability, compliance with regulatory requirements, and effective quality control throughout the production process.
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The purpose of this SOP is to establish a preventive maintenance program for the capsule manufacturing equipment to ensure its optimal performance, reduce downtime, and extend its operational life. Regular preventive maintenance is essential to minimize equipment failure and maintain product quality.
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The purpose of this SOP is to define the procedure for handling rejected capsules during the manufacturing process. Rejected capsules must be properly identified, segregated, and disposed of or reworked in accordance with established procedures to maintain product quality and comply with regulatory standards.
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The purpose of this SOP is to define the procedure for ensuring uniform gelatin shell thickness during the capsule manufacturing process. Achieving consistent shell thickness is crucial for maintaining capsule integrity, ensuring consistent drug release, and complying with product specifications.
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The purpose of this SOP is to outline the procedure for performing visual inspection of capsules during production to ensure that they meet the required quality standards. This is critical for identifying defects such as cracks, improper sealing, or contamination before the capsules are released for further processing.
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The purpose of this SOP is to provide a standardized procedure for adjusting the parameters of the capsule filling machine to ensure consistent capsule fill weight, capsule size, and proper capsule closure. These adjustments are critical for ensuring that all capsules meet the required quality standards and regulatory requirements.
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