The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this SOP is to outline the procedure for screening and selecting polymers suitable for capsule coating to ensure optimal capsule performance, including controlled release, stability, and protection of the active pharmaceutical ingredient (API).
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The purpose of this SOP is to outline the procedure for developing capsule fill formulations, ensuring that the formulations meet regulatory, quality, and performance standards for safe and effective use.
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This SOP defines the procedure for conducting compatibility studies between active pharmaceutical ingredients (APIs) and excipients to ensure that no interactions or incompatibilities affect the performance, stability, or safety of the final capsule formulation.
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This SOP defines the procedures for conducting preformulation studies for capsule dosage forms to ensure the selection of suitable excipients, formulation parameters, and to optimize the development process for capsule formulations.
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This SOP outlines the procedure for training operators in dispensing practices to ensure that all operators understand and comply with the standards and procedures for dispensing materials in capsule manufacturing.
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The purpose of this SOP is to define the procedures for the use of Personal Protective Equipment (PPE) in the dispensing areas of capsule manufacturing to ensure the safety of personnel and the protection of products from contamination.
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This SOP outlines the process for reconciling dispensed materials during capsule manufacturing to ensure that all materials are accounted for accurately and that discrepancies are promptly identified and addressed.
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This SOP defines the procedure for handling and storing gelatin used in the preparation of capsule shells to ensure product quality, safety, and compliance with GMP standards.
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To define the procedures for handling controlled substances during the dispensing process in capsule manufacturing, ensuring compliance with regulatory requirements, and maintaining the security of controlled materials.
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To establish a standardized procedure for using barcode scanning technology to ensure dispensing accuracy in capsule manufacturing, minimizing human errors and improving traceability.
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