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QUESTION: Mike, Hope you are fine.
We have validated a Clinical strength Deodorant formula (3 batches) and currently doing stability studies on the same. We have to make another product with the same formula but different fragrance. Do we have to do another Three (3) process validation batches  and run stability also on this slightly different formulation?
Appreciate your response. Thanks so much!

ANSWER: Dear Lisa:

As long as you can show that the new fragrance (and its solvent) have no impact on formulation properties, stability (expiration date) or equipment cleaning; then NO, you do not need to repeat the 3 validation batches.

I hope this helps,
Merry Christmas,


---------- FOLLOW-UP ----------

QUESTION: Dear Mike,
Thanks for the quick response. Can you please give me some pointers on How to show that the fragrance has no impact on formulation etc.
Any specific tests ? Accelerated stability for 90 days? Really appreciate any suggestions you may have. Have a Merry Christmas and a wonderful New Year!!!

Answer
I would go with a 90 day accelerated stability study with specific tests for impurities - especially check for fragrance specific impurities in a two step manner.

a. If the total impurities stays the same as to that with the original fragrance, stop there and worry no further;
b. If the total impurities rise, or one specific impurity rises

.......... then I believe there might be a fragrance specific impurity issue that will need further investigation, including potentially a toxicity evaluation.

I hope this helps.
Have a great New Year.

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Michael Anisfeld

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Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements

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