The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this SOP is to define the procedure for ensuring uniform gelatin shell thickness during the capsule manufacturing process. Achieving consistent shell thickness is crucial for maintaining capsule integrity, ensuring consistent drug release, and complying with product specifications.
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The purpose of this SOP is to outline the procedure for performing visual inspection of capsules during production to ensure that they meet the required quality standards. This is critical for identifying defects such as cracks, improper sealing, or contamination before the capsules are released for further processing.
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The purpose of this SOP is to provide a standardized procedure for adjusting the parameters of the capsule filling machine to ensure consistent capsule fill weight, capsule size, and proper capsule closure. These adjustments are critical for ensuring that all capsules meet the required quality standards and regulatory requirements.
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The purpose of this SOP is to ensure proper control of temperature and humidity levels in the manufacturing areas to maintain the quality and stability of the capsule formulation. This is essential to meet regulatory standards and ensure the proper functioning of the capsule production process.
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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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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 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 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 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 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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