Você está na página 1de 2

5th Draft

4.7.8. Generic Products


Study

Storage Condition

Long term

30oC 2oC/75% RH
5% RH

Minimum Time
Period Covered by
Data at Submission
6 months

12 months

Accelerated

40oC 2oC/75% RH
5% RH

6 months

Number of Batches

Min. 2
For conventional
dosage form and
stable drug substances
Min.3
For critical dosage
form or unstable drug
substances
Min. 2
For conventional
dosage form and
stable drug substances
Min.3
For critical dosage
form or unstable drug
substances

4.7.9. Variations (MaV and MiV if appropriate)


Once the Drug Product has been registered, additional stability studies are required
whenever variations that may affect the stability of the Drug Products are made, refer to
ASEAN Variation Guideline
Major Variation (MaV)
Study

Storage Condition

Long term

30oC 2oC/75% RH
5% RH

Accelerated

40oC 2oC/75% RH
5% RH

Minimum Time
Period Covered by
Data at Submission
6 months

6 months

Number of Batches

Min. 2
For conventional
dosage form and
stable drug substances
Min.3
For critical dosage
form or unstable drug
substances
Min. 2
For conventional
dosage form and
stable drug substances
Min.3
For critical dosage
form or unstable drug
substances

10

5th Draft

Minor Variaton (MiV)


Study

Storage Condition

Long term

30oC 2oC/75% RH
5% RH

Minimum Time
Period Covered by
Data at Submission
3 months*

6 months

Accelerated

40oC 2oC/75% RH
5% RH

3 months*

6 months

Number of Batches

Min. 2
For conventional
dosage form and
stable drug substances
Min.3
For critical dosage
form or unstable drug
substances
Min. 2
For conventional
dosage form and
stable drug substances
Min.3
For critical dosage
form or unstable drug
substances

Example : replacement of an excipient with a comparable excipient, change in the qualitative


and/or quantitative composition of the immediate packaging material, change in the batch size of
the finished product, minor change in the manufacture of the finished product, change of
colouring system or the flavouring system currently use in the finished product, change in
coating weight of tablets or change in weight of capsule shells, and any other minor variation in
ASEAN Variation Guideline.

(WHO Expert Committee on Specifications forPharmaceutical Preparations, Annex 6: Guidance


on Variations to a Prequalified Product Dossier, WHO Technical Report Series No. 943, 2007)

4.8.

In-use Stability
i.

The purpose of in-use stability testing is to provide information for the labelling on
the preparation, storage conditions and utilization period of multidose products
after opening, reconstitution or dilution of a solution, e.g. an antibiotic injection
supplied as a powder for reconstitution.

ii. As far as possible the test should be designed to simulate the use of the drug
product in practice, taking into consideration the filling volume of the container
and any dilution or reconstitution before use. At intervals comparable to those
which occur in practice appropriate quantities should be removed by the
withdrawal methods normally used and described in the product literature.
iii. The physical, chemical and microbial properties of the drug product susceptible to
change during storage should be determined over the period of the proposed in-use
shelf-life. If possible, testing should be performed at intermediate time points and
at the end of the proposed in-use shelf-life on the final amount of the drug
remaining in the container. Specific parameters, e.g. for liquids and semi-solids,
preservatives, per content and effectiveness, need to be studied.
iv. A minimum of two batches, at least pilot-scale batches, should be subjected to the
test. At least one of these batches should be chosen towards the end of its shelf11

Você também pode gostar