The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this SOP is to establish a standardized procedure for the validation of analytical methods used to test capsules. Validating analytical methods ensures that they are reliable, reproducible, and capable of providing accurate results for critical quality attributes of capsules such as potency, purity, dissolution, and content uniformity.
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The purpose of this SOP is to outline the process for validating dust extraction systems used in capsule manufacturing facilities. Dust extraction systems are crucial for maintaining a clean and safe working environment by capturing and removing airborne particulates during the manufacturing process. This SOP ensures that the dust extraction system operates efficiently, meets GMP requirements, and complies with safety standards for capsule production.
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The purpose of this SOP is to provide a standardized procedure for validating dehumidifiers used in capsule manufacturing areas. Dehumidifiers are essential for controlling the humidity levels in the production environment, which directly affects the quality and stability of capsules. This SOP ensures that the dehumidifiers operate efficiently and maintain the required environmental conditions to comply with GMP and regulatory standards.
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The purpose of this SOP is to define the process for validating water systems used in capsule shell production. The water used in capsule manufacturing must meet specific purity and quality standards to ensure the safety, efficacy, and compliance of the final product. This SOP provides guidelines for validating the water system, including testing for quality, purity, flow rates, and system integrity.
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The purpose of this SOP is to provide guidelines for validating the compressed air systems used in capsule production. The compressed air system is critical for powering equipment, ensuring cleanliness, and maintaining optimal environmental conditions. This SOP ensures that the compressed air system operates within the specified parameters and complies with GMP and regulatory requirements.
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The purpose of this SOP is to outline the procedure for validating HVAC (Heating, Ventilation, and Air Conditioning) systems in capsule manufacturing areas. The HVAC system is critical to maintaining the required environmental conditions (temperature, humidity, airflow, and cleanliness) that support GMP and regulatory compliance. This SOP ensures that the HVAC system operates within acceptable limits, ensuring the quality of the capsules and the safety of the manufacturing environment.
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The purpose of this SOP is to outline the validation process for capsule size sorting machines used in the capsule manufacturing process. The validation ensures that the machine can accurately sort capsules according to size, ensuring uniformity and consistency in the final product. This SOP ensures the equipment is operating within the specified limits and complies with GMP and regulatory standards.
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The purpose of this SOP is to provide guidelines for validating capsule weight monitoring equipment used in the capsule manufacturing process. Weight monitoring equipment is essential for ensuring that each capsule meets the specified weight criteria and that the production process remains compliant with GMP standards. This SOP ensures that the equipment is calibrated, operates accurately, and provides consistent measurements during production.
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The purpose of this SOP is to define the Performance Qualification (PQ) process for capsule printing machines. PQ is designed to ensure that the capsule printing machine operates according to the required specifications during actual production conditions. This SOP ensures that the capsule printing machine performs effectively, producing quality products in compliance with GMP and regulatory standards.
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The purpose of this SOP is to outline the Operational Qualification (OQ) process for capsule inspection machines. OQ ensures that the capsule inspection machine operates within specified limits and performs as expected during production. This SOP provides a structured approach to validating the operational functionality of the capsule inspection machine in compliance with GMP and regulatory standards.
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