QAS-013 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 300

SOP No. QAS-013.00 Effective date: mm/dd/yyyy
Approved by:

Subject: Stability Testing Guideline

32.1 PurPose
To assure 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.

32.2 resPonsibility
It is the responsibility of stability laboratory analysts to follow the procedure. The stability/QC
manager is responsible for procedure compliance.

32.3 scoPe

A. The stability program provides analytical data for active ingredients and other measurable
parameters which are affected by time and relevant conditions.

B. Stability studies are performed on

1. Product to be submitted for registration

2. Scale-up batches

3. Product where relevant changes have been made in the manufacturing procedure

4. Product where significant changes have been made in the packaging material

C. This program also provides data which can support the revision of expiration date, manu-
facturing excess, container change, etc.

32.4 Procedure

32.4.1 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.

32.4.2 t eSt P rocedureS and t eSt c riteria

1. The testing should cover those features susceptible to change during storage and that are
likely to influence quality, safety, and/or efficacy.

2. All analytical test procedures should be fully validated and the assays should be
stability-indicating.

32.4.3 S PecificationS

1. Limits of acceptance should relate to the release limits (where applicable).

2. The shelf life specifications could allow acceptable and justifiable derivations from the
release specifications based on the stability evaluation and the changes observed on
storage.

32.4.4 S torage t eSt c onditionS /f reQuency
The length of the studies and the storage conditions should be sufficient to cover storage, shipment,
and subsequent use (e.g., reconstitution or dilution as recommended in the labeling). See the table