SOPs for Capsules V 2.0

The purpose of this SOP is to outline the Installation Qualification (IQ) process for capsule filling machines. IQ is an essential step in the validation of new or modified equipment to ensure that it is installed correctly, meets design specifications, and is suitable for use in capsule production. This SOP ensures compliance with GMP and regulatory standards and provides a systematic approach to documenting the IQ process.

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The purpose of this SOP is to outline the cleaning validation procedures for drying trays and racks used in capsule manufacturing. Proper cleaning of drying equipment is essential to avoid contamination and ensure the safety and quality of the capsules. This SOP ensures that the cleaning procedures for drying trays and racks are validated, reproducible, and compliant with GMP and regulatory standards.

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The purpose of this SOP is to define the cleaning validation procedures for soft gelatin capsule production lines. Cleaning validation ensures that all equipment used in the production of soft gelatin capsules is cleaned thoroughly between manufacturing batches to prevent cross-contamination and ensure product quality. This SOP ensures that cleaning procedures are effective, reproducible, and compliant with GMP and regulatory requirements.

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The purpose of this SOP is to define the cleaning validation procedures for capsule polishing machines in capsule manufacturing. Cleaning validation is essential to prevent cross-contamination between batches and ensure that no residues from previous batches remain on the machines. This SOP ensures that cleaning procedures are consistent, reproducible, and comply with GMP and regulatory standards.

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The purpose of this SOP is to outline the procedures for cleaning validation of gelatin preparation equipment used in capsule manufacturing. Ensuring the cleanliness of gelatin preparation equipment is critical to prevent cross-contamination and ensure the quality and safety of the finished capsules. This SOP defines the cleaning validation process to ensure compliance with GMP and regulatory standards.

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The purpose of this SOP is to outline the procedures for validating the cleaning process of capsule fill machines. Ensuring that capsule fill machines are cleaned thoroughly and effectively between manufacturing batches is critical for preventing cross-contamination and ensuring product quality. This SOP ensures that cleaning procedures are consistent, reproducible, and compliant with GMP and regulatory standards.

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The purpose of this SOP is to outline the procedures for cleaning validation during process validation in capsule manufacturing. This process ensures that all equipment used in the production of capsules is thoroughly cleaned between batches to prevent cross-contamination and ensure product quality. It ensures that cleaning procedures are effective, reproducible, and compliant with GMP and regulatory requirements.

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The purpose of this SOP is to define the process for validating the encapsulation of liquid fill materials in capsules. Liquid-filled capsules require careful formulation, encapsulation, and sealing to ensure that the fill material is contained securely and meets the required quality standards for pharmaceutical use. This SOP ensures the encapsulation process is consistent, reproducible, and compliant with GMP and regulatory standards.

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The purpose of this SOP is to outline the process for validating the manufacturing process for controlled-release capsules. Controlled-release capsules are designed to release the active pharmaceutical ingredient (API) in a controlled manner over a specified period. This SOP ensures that the controlled-release process is consistent, reproducible, and compliant with regulatory and quality standards.

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The purpose of this SOP is to outline the process for validating the enteric coating process for capsules. The enteric coating is applied to capsules to prevent premature disintegration in the stomach and to ensure drug release in the intestine. This SOP ensures the coating process is consistent, reproducible, and compliant with regulatory and quality standards.

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