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Company news about How to document and validate the emulsification process for regulatory compliance?

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How to document and validate the emulsification process for regulatory compliance?

2025-12-15

How to document and validate the emulsification process for regulatory compliance?

A: Documentation and validation steps include: (1) Establishing Standard Operating Procedures (SOPs) for equipment operation, cleaning, and maintenance, and ensuring all operators follow them; (2) Conducting Process Validation: Including installation qualification (IQ) to verify equipment installation meets requirements, operational qualification (OQ) to confirm the equipment functions properly within specified parameters, and performance qualification (PQ) to demonstrate the process consistently produces products that meet quality standards; (3) Maintaining Detailed Records: Recording process parameters (speed, temperature, time), raw material information, cleaning and sterilization records, and quality test results for at least the shelf life of the product (or as required by regulations); (4) Regular Audits: Conducting internal and external audits to ensure compliance with regulatory standards and identifying areas for improvement.
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Company news about-How to document and validate the emulsification process for regulatory compliance?

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How to document and validate the emulsification process for regulatory compliance?

2025-12-15

How to document and validate the emulsification process for regulatory compliance?

A: Documentation and validation steps include: (1) Establishing Standard Operating Procedures (SOPs) for equipment operation, cleaning, and maintenance, and ensuring all operators follow them; (2) Conducting Process Validation: Including installation qualification (IQ) to verify equipment installation meets requirements, operational qualification (OQ) to confirm the equipment functions properly within specified parameters, and performance qualification (PQ) to demonstrate the process consistently produces products that meet quality standards; (3) Maintaining Detailed Records: Recording process parameters (speed, temperature, time), raw material information, cleaning and sterilization records, and quality test results for at least the shelf life of the product (or as required by regulations); (4) Regular Audits: Conducting internal and external audits to ensure compliance with regulatory standards and identifying areas for improvement.
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