The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this SOP is to define the procedure for conducting shelf-life prediction studies for capsules. These studies are critical in determining the stability and expiry date of capsules, ensuring their effectiveness, safety, and compliance with regulatory standards over time.
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The purpose of this SOP is to establish a systematic approach for validating capsule development procedures. It ensures that all processes related to capsule formulation, filling, and sealing are performed under controlled conditions and meet regulatory and quality standards.
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The purpose of this SOP is to establish a consistent procedure for formulating high-potency drugs in capsules. High-potency drugs require special handling and formulation techniques due to their small therapeutic dose and potential risk to personnel during production.
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The purpose of this SOP is to outline the procedure for designing extended-release (ER) capsule formulations. The aim is to develop capsules that provide a controlled release of the active pharmaceutical ingredient (API) over an extended period, ensuring that the drug is released gradually and consistently for optimal therapeutic effects.
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The purpose of this SOP is to outline the process for developing moisture barrier coatings for capsules to protect the fill material from environmental conditions such as moisture and humidity. The barrier ensures that the capsules maintain their integrity, stability, and performance throughout their shelf life.
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The purpose of this SOP is to define the procedure for optimizing the capsule sealing process to ensure uniform, efficient, and secure sealing of capsules. Proper sealing is crucial for preventing content leakage, ensuring product integrity, and enhancing shelf life.
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The purpose of this SOP is to define the procedure for conducting encapsulation trials using new fill materials. Encapsulation trials are essential for ensuring the compatibility of new fill materials with the capsule manufacturing process, as well as verifying that the material can be encapsulated effectively while maintaining the quality of the final product.
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The purpose of this SOP is to establish the procedure for selecting the appropriate capsule size for different formulations. The goal is to ensure that the selected capsule size accommodates the required dose, ensuring both the stability and ease of administration of the final product.
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The purpose of this SOP is to define the procedure for conducting stability studies during capsule formulation development. Stability testing ensures that the developed formulation maintains its intended quality, safety, and efficacy over time under various environmental conditions.
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The purpose of this SOP is to outline the procedure for preparing development reports for capsule dosage forms. These reports are critical for documenting the formulation, development process, and testing results, ensuring that the capsules meet all required specifications for efficacy, safety, and stability.
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