3. Storage areas
Entry
Order
Good SC
Clean
Separate sampling area
GMP handling
Adequate lighting
4. Monitoring of storage conditions
Storage conditions for pharmaceutical products and
materials should be in compliance with the labelling,
which is based on the results of stability testing.
5. General storage conditions
Long term- 25- 12 months.
Intermediate- 30- 6 months.
Accelerated- 60- 6 months.
6. Storage conditions in refrigerator
Long term – 5- 12 months.
Accelerated – 25- 6 months.
8. IPEC Storage Conditions
Stability data.
Accelerated stability is used to support long term
stability.
Fulfill labeling requirements.
9. Storage conditions for compatibility study
Vary according to temperature and
humidity.
In general, 50 is appropriate.
Some substance require higher
temperature.
10. Criteria for Storage
Conditions
Sample of API & excipients must be
retained.
Containers must assure API &
excipients are protected throughout the
retention time.
11. Storage requirements
Documentation-written instructions & records..
Labelling & containers
Receipt of incoming materials & pharmaceutical products.
Stock rotation and control.
Control of obsolete and outdated materials and
pharmaceutical products.
12. Materials requiring special
storage
IV medicines
IV doses
Refrigerators- pharmaceutical grade
Refrigerators- monitored for adequate
storage conditions.
