Sterile products processing relates to how sterile drug products are manufactured using aseptic (or free from contamination) process methods where the drug substance, excipients, and vehicle (e.g., saline or water for injection) are combined and filled into a container (such as a syringe)
Related Guidance Documents
Manufacturing Operations (1)
Microbiological & Viral Contamination Control (1)
Sterile Products (1)
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