Checklist for stability study

Study elaborated by: Address

Climatic zone
API:
Description of API

Molecular formula:
Structural formula:

Chemical name(INN):

Packaging (material and type)

1. glass bottle □ vial □ ampoule □
2. plastic bottle □ vial □ ampoule □
3. paper box □ bag □
4. other (please state)

State of packaging intact □ damaged □

Storage conditions
manufacturer’s indications
Shelf-life (if available)
claimed by the manufacturer ……years ……months
percentage elapsed when tested …… %

Source of product tested

Manufacturer …………………………………………………………………………….
Address …………………………………………………………………………………..
______________________________________________________________
Batch identification

Batch number Date of manufacture Expiry date

1 ..............… ../../20.. ../../20..
2 .................. ../../20.. ../../20..
3 .................. ../../20.. ../../20..

Batch size Type of batch (experimental, pilot plant, production)

1 .................. ………………………………….
2 .................. ………………………………….
3 .................. ………………………………….
Samples tested (per batch) ……..

Stability program
Stress conditions/Accelerated/real-time studies
Storage/test conditions:
Temperature ... °C Humidity …%
Light …
Study type: investigational preliminary/investigational complete/ confirmatory/ on going
Testing frequency: (months)
0□ 3□ 6□ 9□ 12□ 18□ 24□ 36□ 48□ 60□
Specification
Pharmacopoeial/ non pharmacopoeial monograph Acceptance criteria
1. Identification □
2. Assay □
3. Purity tests □
4. other test(s)
___________________________________________________________________
Validated analytical procedures?
Yes/No/ Partial
…………………………………………………………………………………………

Stability commitment
Data is covering the proposed re-test period?
Yes/No
Production batches?
Yes/No
Fewer than three production batches?
Yes/No
……………………………………………………………………………………………………
…………………………………………………………………………………………………..

Results
1. Chemical findings ………………………………………………………………….
……………………………………………………………………………………..

2. Microbiological and biological findings …………………………………………...

………………………………………………………………………………………

3. Physical findings ……………………………………………………………………

………………………………………………………………………………………

Evaluation

Data variability……………………………………………………………………………..

Statistical analysis necessary?................................................................................................

Conclusions ……………………………………………………………………
………………………………………………………………………………………

‡ Recommended storage conditions

‡ A retest period

Responsible officer ......................................................... Date ../../20