CONTINUE TO SITE

OR WAIT null SECS

Analytics Dosage Forms Drug Development Manufacturing Outsourcing Quality Systems

AnalyticsDosage FormsDrug DevelopmentManufacturingOutsourcingQuality Systems

View More COVID-19 Update Analytical Method Development APIs Aseptic Processing Biologic Drugs Drug Delivery Equipment Excipients Formulation Packaging Process Control/PAT Process Development QA/QC Regulatory Action Supply Chain

COVID-19 UpdateAnalytical Method DevelopmentAPIsAseptic ProcessingBiologic DrugsDrug DeliveryEquipmentExcipientsFormulationPackagingProcess Control/PATProcess DevelopmentQA/QCRegulatory ActionSupply Chain

News

All News Top News Industry News Bio/Pharma News Supplier News News from Europe Events

All NewsTop NewsIndustry NewsBio/Pharma NewsSupplier NewsNews from EuropeEvents

Publications

All Publications PharmTech PharmTech Europe

All PublicationsPharmTechPharmTech Europe

Resources

Front & Center Pharma Insights Sponsored eBooks Sponsored Podcasts Sponsored Videos Whitepapers

Front & CenterPharma InsightsSponsored eBooksSponsored PodcastsSponsored VideosWhitepapers

Webcasts Marketplace

Multimedia

Drug Digest Videos Drug Solutions Podcast

Conference

Conference Coverage Conference Listing

Business

Enewsletters Magazine North America Magazine Europe

EnewslettersMagazine North AmericaMagazine Europe

About Us
Advertise
Contact Us
Editorial Info
Editorial Contacts
Editorial Advisory Board
Do Not Sell My Personal Information
Privacy Policy
Terms and Conditions

Spotlight

Analytics
Dosage Forms
Drug Development
Manufacturing
Outsourcing
Quality Systems

TopicSee All >

COVID-19 Update
Analytical Method Development
APIs
Aseptic Processing
Biologic Drugs
Drug Delivery
Equipment
Excipients
Formulation
Packaging
Process Control/PAT
Process Development
QA/QC
Regulatory Action
Supply Chain

About Us
Advertise
Contact Us
Editorial Info
Editorial Contacts
Editorial Advisory Board
Do Not Sell My Personal Information
Privacy Policy
Terms and Conditions

Deborah F. Johnson

home

Articles

Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug Substances

March 15, 2016

The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.