Doing work as a consultant brings me to see many facilities. I am amazed with the high numbers of licensed manufacturers being unaware of the needs to conduct stability studies for all registered products; be it theirs or products owned by others (contract givers).
It is prudent to note that the responsibility is on the product licensed holder to conduct a Real Time stability study as per the ASEAN Stability study guideline, once the product is registered and manufactured. Your product may be withdrawn if this is not done.
To conduct stability study, you just need to take 3 different batches of each product. It further amazed me when manufacturers took the pain to keep samples from EVERY batches produced for the stability study..! No wonder some people are so tied down with work that they are unable to see what exactly are required for the stability study.
The storage condition is another common blunder where you can see stability samples kept in a conditoned different from the recommended storage condition as stated on label. Such act will simply invalidate all the effort done in your stability studies.
My suggestion...... please find some time to read up the guideline and plan for your stability study program. The time spent is worth the effort taken.
AJ.
Friday, April 9, 2010
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