Master File Submission (API)

Master File Submission (API)

USDMF

  • For Pharmacopoeia and internal quality active substance DMF development advice
  • Writing in CTD & submission in eCTD to CDER, FDA
  • Deficiency response for complete assessment review of DMF
  • Maintaining Active status of DMF
  • Support in major change update

ASMF & CEP

ASMF (EU-MSs)
  • For Pharmacopoeia and non-pharmacopoeia API
  • Writing Applicant part (AP) and Restricted Part (RP) of ASMF
  • Submission to each MSs
  • Query response
  • ASMF acceptance
CEP (EDQM)
  • For Pharmacopoeia API
  • Writing Applicant Part (AP) and Restricted Part (RP)
  • EDQM submission
  • Query response
  • Support for EDQM site inspection
  • CEP approval letter

API QP AUDIT

Third Party API QP Audit
Experienced EU QP Auditor
Audit
Report
3 Years
Valid
CAPA
Preparation
Submission to Single EU GP
CAPA Acceptance by EU QP Auditor
QP
Declaration
Informal Mileage
  • One- time audit by an independent auditor for single API
  • Conserves company’s resources (i.e. cost of travel and stay for buyer specific auditor, one-time engagement of manufacturing and QA personnel)
  • One single QP audit can replace numerous MA holder audits
  • Single comprehensive CAPA execution to independent EU QP auditor as against multiple CAPAs to different EU QP auditors
  • Reduced major observations during renewal inspections since EU QP audit by ex-agency inspector

Master File Submission (API) - Case Study

Read how we imparted in technical review of ASMF