Biomedical Engineering Reference
In-Depth Information
SOP No. QCS-014.00 Effective date: mm/dd/yyyy
Approved by:
14.1 PurPose
To ensure that marketed products and samples, at the customer's end, meet label claim, regulatory
requirements, and ABC Pharmaceutical Company's standards during stated expiration dating.
14.2 resPonsibility
It is the responsibility of the stability supervisor to follow up the procedure; the R&D manager is
responsible for the SOP compliance.
14.3
scoPe
1. Stability program provides analytical data for active ingredients and other measurable
parameters that are affected by time and relevant conditions.
2. Stability test will be performed
a.
On routine production batches
b.
If relevant changes have been made in the manufacturing procedure
c.
In the event of significant changes in primary packaging
d.
Where new grade excipients which might affect stability are to be employed
e.
In problem cases
f.
On the first three representative trial batches of newly developed formulation
3. This program also provides data which can support the revision of expiration date, manu-
facturing excess, container change, and so on.
14.4
Procedure
14.4.1
S
election
of
B
atcheS
1. Stability information for accelerated and long-term testing is to be provided on three
batches of the same formulation and dosage form in the containers and closure proposed
for marketing.
2. The long-term testing should cover at least 12 months duration at the time of submission.
3. Data on associated formulations or packaging may be submitted as supportive information.
The first commercial batch manufactured post approval, if not submitted in the original
registration application, should be placed on accelerated and long-term stability studies
using the same stability protocols as in the approved drug application.
14.4.2 t
eSt
P
rocedureS
and
t
eSt
c
riteria
The testing should cover those features that are susceptible to change during storage and are likely
to influence quality, safety, and/or efficacy.
14.4.3
S
PecificationS
1. Limits of acceptance should relate to the release limits (where applicable).
2. The shelf life specification could allow acceptable and justifiable derivations from the
release specification based on the stability evaluation and the changes observed on
storage.
3. It will need to include specific upper limits for degradation products, the justification for
which should be influenced by the levels observed in batches used in preclinical studies
and clinical trials (where applicable).
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