aseptic processing / sterile drug products / thermal processing / antibiotic drug applications / investigational new animal drug applications / penetration study protocols / animal drug applications / drug product / to previously approved applications / validation protocol / proposed drug product / sterile processing / sterile product / manufacturing / antibiotic applications / human and animal drug applications / human and veterinary drug products / /
MedicalCondition
sterility / /
Organization
Human and Veterinary Drug Products Center for Drug Evaluation / Food and Drug Administration / Chemistry Manufacturing Controls Coordinating Committee / Division of Communications Management / Sterility Technical Committee / Center for Drug Evaluation and Research / Center for Veterinary Medicine / / /
Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products