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 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 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 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 provide a standardized procedure for identifying and resolving issues encountered during the capsule filling process. This includes addressing problems related to capsule filling machines, ensuring minimal downtime, and maintaining production efficiency.
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The purpose of this SOP is to establish a standardized procedure for operating capsule printing machines. This includes guidelines for the preparation, setup, operation, and maintenance of the printing machine to ensure consistent, accurate, and high-quality printing on soft gelatin capsules.
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The purpose of this SOP is to outline the standardized procedure for layering pellets with active pharmaceutical ingredients (APIs) and excipients for capsule fill materials. The goal is to ensure the accurate and uniform application of layers, thereby achieving the desired release profile and bioavailability of the drug.
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The purpose of this SOP is to provide a standardized procedure for adjusting the parameters of the capsule sealing machine. Proper adjustment of sealing parameters is crucial to ensure a consistent, reliable seal that prevents leakage and ensures the integrity of the capsule.
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The purpose of this SOP is to outline the procedure for identifying, segregating, and handling deformed capsules during production. Deformed capsules can negatively affect product quality, and this SOP ensures that any defective capsules are appropriately managed to maintain the integrity of the batch.
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The purpose of this SOP is to outline the standardized procedure for setting up capsule banding equipment. The capsule banding process ensures that the capsules are sealed with a band of gelatin or other material for visual identification and protection, and this SOP aims to ensure that the setup is performed correctly for optimal product quality and compliance.
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