The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this SOP is to provide a standard method for preparing liquid formulations for soft gelatin capsules. The process involves preparing active pharmaceutical ingredients (APIs) and excipients in liquid form, ensuring uniformity and stability before encapsulation.
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The purpose of this SOP is to define the standard operating procedures for the operation of capsule filling machines. This procedure ensures that the capsule filling process is efficient, accurate, and complies with all regulatory and quality standards.
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The purpose of this SOP is to define the procedure for monitoring the formation of capsule shells during the encapsulation process. This includes ensuring that the capsule shells are formed with the correct integrity, thickness, and uniformity to meet product specifications.
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The purpose of this SOP is to establish the procedures to prevent cross-contamination during the capsule manufacturing process. This ensures the integrity of the capsules and prevents contamination from one batch to another, preserving product quality and patient safety.
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The purpose of this SOP is to outline the procedure for sampling in-process capsules during the manufacturing process for quality control checks. Regular sampling is critical for verifying the uniformity, integrity, and compliance of capsules with regulatory and quality standards.
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The purpose of this SOP is to define the procedure for drying hard gelatin capsules after the filling process. This ensures that capsules achieve the proper moisture content, which is crucial for maintaining their integrity, stability, and ease of handling.
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The purpose of this SOP is to define the procedure for sealing soft gelatin capsules to ensure that they are properly sealed to prevent leakage of fill material, contamination, or degradation. Proper sealing is critical for maintaining the integrity and stability of the capsule.
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The purpose of this SOP is to define the procedures for conducting online inspection of capsules during the filling process. This ensures that capsules are filled properly and meet the required specifications for size, fill weight, and uniformity before they are sealed and processed further.
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The purpose of this SOP is to outline the procedures for identifying and handling overfilled or underfilled capsules during the manufacturing process. This ensures that all capsules meet the required fill weight specifications, maintaining the quality and integrity of the final product.
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The purpose of this SOP is to outline the process for ensuring uniformity of capsule weight during production. This is essential to meet regulatory standards, improve product quality, and maintain consistency across capsules in terms of both weight and active ingredient content.
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