Module 12 2019

Variations and IDMP

Optimising variations process o

A total of 35-40% of type-IA variations could be reduced by reporting administrative changes directly into the IDMP database (Admin changes of Organisations and CEP updates)

Variation Guideline number

Type of variation Update of

Description

%

BIII1A2

CEP for active substance

15.06% 8.30% 6.18% 5.70% 4.69%

CIZ

Submission of Other variation

A7

Deletion of Change in Replacement of Replacement of Deletion of Replacement of Replacement of Addition of Change in Change in

DS-manufacturer

BIID2A BIIB1A

approved test procedure Secondary packaging site

BIIB3A BIIB2A

manufacturing process batch control/testing site

4.43% 4.34%

BIID1D BIIB5Z BIIB1B

specification parameter in-process test or limits Primary packaging site

3.81% 3.75% 3.46%

BIIB2C1

batch release site, not including batch control/testing

3.20%

BIID1C BIID1A BIIB4A

specification parameter specification parameter

2.10% 2.06% 1.88% 1.84%

Change in Change in

Batch size

CI3A

Submission of changes requested by EMA/NCA

The Organisation for Professionals in Regulatory Affairs