eo sterilization validation – Pharma Validation

Documentation Requirements for Cleaning Contractor Qualification

Documentation Requirements for Cleaning Contractor Qualification Documentation Requirements for Cleaning Contractor Qualification In the pharmaceutical and biologics sectors, ensuring the safety and quality of products is paramount. One critical aspect of this process is the effective validation of cleaning contractor…

Periodic Requalification of GMP Service Providers

Periodic Requalification of GMP Service Providers Periodic Requalification of GMP Service Providers The pharmaceutical and medical device industries operate under stringent regulatory requirements, particularly regarding the manufacture and sterilization of products. Validating sterilization processes, including ethylene oxide (EO) sterilization, is…

How Many Runs Are Needed for Hold Time Validation?

How Many Runs Are Needed for Hold Time Validation? How Many Runs Are Needed for Hold Time Validation? Validation is a critical aspect of the pharmaceutical and medical device industries, ensuring that processes meet regulatory standards and produce safe, effective…

How to Set Acceptance Criteria for Hold Time Studies

How to Set Acceptance Criteria for Hold Time Studies How to Set Acceptance Criteria for Hold Time Studies In the pharmaceutical and medical device industries, the validation of sterilization processes is critical to ensure the safety and efficacy of products.…