The Ultimate Resource for Pharmaceutical SOPs and Best Practices
This SOP outlines the procedure for applying a protective seal coating on sugar-coated tablets. The protective seal coating ensures that the sugar coating remains intact and provides additional protection against environmental factors, such as moisture, while preserving the tablet’s integrity and ensuring its shelf-life.
Click to read the full article.
The purpose of this SOP is to establish guidelines for in-process control during the film coating process of tablets. In-process control ensures that the coating is applied uniformly, meets quality specifications, and prevents defects such as uneven coating, cracking, or poor adhesion.
Click to read the full article.
The purpose of this SOP is to establish a systematic procedure for cleaning tablet compression equipment after each batch. The cleaning process ensures that no cross-contamination occurs between batches and that the equipment is sanitized for optimal performance and compliance with GMP.
Click to read the full article.
This SOP outlines the procedure for applying a moisture barrier coating on tablets. The moisture barrier coating protects the tablets from environmental moisture, which can affect the stability and integrity of the tablet, particularly for moisture-sensitive ingredients.
Click to read the full article.
The purpose of this SOP is to provide guidelines for reducing dust generation during tablet manufacturing. Dust can pose risks to worker health, compromise product quality, and lead to inefficiencies in the manufacturing process. This SOP aims to minimize dust exposure and improve the overall manufacturing environment.
Click to read the full article.
This Standard Operating Procedure (SOP) provides guidelines for the proper storage of intermediate products during tablet manufacturing. Proper storage conditions are essential to maintaining the quality, stability, and integrity of intermediate products before they undergo further processing.
Click to read the full article.
This Standard Operating Procedure (SOP) outlines the procedure for optimizing the high shear granulation process in tablet manufacturing. The objective is to ensure uniformity in granule size, improve batch-to-batch consistency, and enhance the quality of the final tablets.
Click to read the full article.
The purpose of this Standard Operating Procedure (SOP) is to define the methodology for fluidized bed granulation in tablet manufacturing. Fluidized bed granulation is used to enhance the flow properties of powders, improve the uniformity of blends, and ensure the consistency of the final tablet formulation.
Click to read the full article.
This Standard Operating Procedure (SOP) outlines the process for monitoring and adjusting tablet compression force during the tablet manufacturing process. Proper compression force ensures that tablets are formed with the desired hardness, weight, and consistency, meeting quality specifications.
Click to read the full article.
This Standard Operating Procedure (SOP) outlines the steps necessary to achieve consistent tablet thickness during the tablet manufacturing process. Ensuring uniform tablet thickness is essential for product quality, dosage accuracy, and efficient packaging.
Click to read the full article.