CRED Managing Variations Effectively



Risk analysis for variations : weigh up the risks Magnitude of the change : impact on Q, S, E

B.II.a.3 Change in composition (excipients) of the finished product

Consider the difference between e.g. reformulation by :-

Change code B.II.a.3

Proposed change

% total

Category

a) 1, 2

Colour/flavour

≈ 2%

IA

b) 1

Bulking agent  minor adjustment  significant adjustment - e.g. homogeneity

≈ 5% ≈ 50%

IA IB (default)

≈ 15% ≈ 80%

IB

b) 6

New disintegrant Composition of all excipients

Risk

II (Annex II)

z)

Magnitude: Do not apply the same requirements to all

160