CRED Managing Variations Effectively

Chapter B – example cont.

B.II.e.5 Change in pack size of the finished product

Conditions to be fulfilled

Documentation to be supplied

Procedure type

a) Change in the number of units (e.g. tablets, ampoules, etc.) in a pack 1. Change within the range of the currently approved pack sizes

1, 2

1, 3

IA IN

1, 2, 3

IB

2. Change outside the range of the currently approved pack sizes

b) Deletion of pack size(s)

3

1, 2

IA

c) Change in the fill weight/fill volume of sterile multidose (or single-dose, partial use) parenteral medicinal products, including biological/ immunological medicinal products.

II

d) Change in the fill weight/fill volume of nonparenteral multi- dose (or single-dose, partial use) products

1, 2, 3

IB

Introduction to Classification of CMC (Quality) / Clinical / PhV Variations

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