WHO Technical Report Series, No. 981 - World Health Organization

WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report
3.2. S.7 Stability
Description of change
Conditions to
be fulfilled
Documentation
required
Reporting
type
20 Change in the retest period or shelf-life of the API involving:
20a
any change (APIMF
procedure)
4 4 IN
20b reduction 3 1–2 IN
20c extension 1–2 1–3 Vmin
Conditions to be fulfilled
1. No change to the primary packaging in direct contact with the API or to the
recommended condition of storage.
2. Stability data were generated in accordance with the currently accepted stability
protocol.
3. The change is not necessitated by unexpected events arising during manufacture or
because of stability concerns.
4. The revised retest period has previously been accepted through the APIMF
procedure.
Documentation required
1. (S.7.1) Proposed retest period or shelf-life, summary of stability testing according to
currently accepted protocol and test results.
2. (S.7.2) Updated post-acceptance stability protocol and stability commitment and
justification of change, when applicable.
3. (S.7.3) Stability data to support the change.
4. A copy of the APIMF acceptance letter.
WHO Technical Report Series No. 981, 2013
126
Description of change
Conditions to
be fulfilled
Documentation
required
21 Change in the labelled storage conditions of the API involving:
21a
21b
any change in storage
conditions (APIMF
procedure)
any change in storage
conditions
Reporting
type
1 1 IN
2 2 Vmin
Conditions to be fulfilled
1. The revised storage conditions have previously been accepted through the APIMF
procedure.
continues