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Glossary of Applied Terminology for the Pharmaceutical Industry

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Application Data Owner
Archival
Archival Function
Archive (noun)
Archive Data Owner
Archiving
Authenticity
Change Advisory Board Emergency Committee (CAB-EC)
Change Manager
Clean Steam or Pure Steam
Configuration Management
Deoxyribonucleic Acid
Extensible Mark-up Language (XML)
GxP Regulation
High Efficiency Particulate Air (HEPA) Filter
Quality Assurance/Control
Risk to Patient
Risk to Product
Submission Information Package (SIP)
Swab Sampling
System Specifications
Trustworthy Record
(Good Automated Manufacturing Practice)
(ICH Q3C) Organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug prod

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