The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this SOP is to outline the procedure for the post-encapsulation drying process of soft gelatin capsules. The objective is to remove excess moisture from the freshly encapsulated soft gelatin capsules to ensure they achieve the correct moisture content, improving their stability and shelf life.
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The purpose of this SOP is to establish a standard procedure for the encapsulation of liquid active pharmaceutical ingredients (APIs) in soft gelatin capsules. The goal is to ensure the accurate filling of capsules with liquid APIs while maintaining consistency, quality, and compliance with regulatory requirements.
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The purpose of this SOP is to outline the procedure for mixing semi-solids intended for soft gelatin capsule filling. Proper mixing of semi-solids is essential to ensure uniform distribution of active pharmaceutical ingredients (APIs) and excipients, achieving the desired consistency and quality of the final product.
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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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