Table 1 List of Acronyms

ALCM

Analytical Life Cycle Management

AQbD

Analytical Quality by Design

ASAP

Accelerated Stability Assessment Program

ATP

Analytical Target Profile

CBE

Change Being Effective

CE-SDS

Capillary Electrophoresis -- Sodium dodecyl sulfate

CMA

Critical Method Attribute

CQA

Critical Quality Attribure

CTA

Clinical Trial Application

DP

Drug Product

DS

Drug Substance

EM

Emerging Market

EU

European Union

IMPD

Investigational Medicinal Product Dossier

IQ

Inovation and Quality

IR

Immediate Release

KMP

Key Method Parameter

MA

Marketing Application

MR

Modified Release

NCE

new chemical entity

PA

Post Approval

PAC

Post Approval Change

PAS

prior approval supplement

PCV

Polychlorovinyl

QbD

Quality by Design

SLLA

shelf-life limiting attributes

SRA

Stability Risk Assessment

SRQA

stability related quality attributes

UHPLC

Ultra High Pressure Liquid Chromatography

WRD

Worldwide Research and Development