The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.