Regulatory Open Forum

I recommend doing E/L studies using your specific product and specific container closure system. Please also note that you need to ensure the compatibility of the entire contact system during manufacturing with regard to potential leachables in the finished dosage form.

Ravi S. Harapanhalli, Ph.D.

Potomac, MD 20854

ravi.harapanhalli@gmail.com

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Ravi Harapanhalli
Principal
Potomac MD
United States

Original Message:
Sent: 10-01-2015 06:12
From: Mir Hossain
Subject: Leachable and Extractable test for Ophthalmic ANDA

Hello

 

Is it required to do the Leachable and Extractable test for container closure system of Ophthalmic product, targeting for ANDA filing? Please note that both RLD and generic have got the same Q1Q2 composition and also the same type of container closure system (LDPE container) .

Can anybody help me out on any guidance on this issue, please? 

 

Best Regards

 

Mir Motaher Hossain | Sr. Manager, Regulatory Affairs | Cell +88 01713336904  I

 

 

 

 

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In my experience, the testing is not required when the formulation is known to be Q1/Q2 and the same container closure resin is used.  FDA has approved ANDAs without the testing.

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Janet DeLeon
CEO
DeLeon Pharmaceutical Consulting, LLC
Leawood KS
United States

Original Message:
Sent: 10-01-2015 06:12
From: Mir Hossain
Subject: Leachable and Extractable test for Ophthalmic ANDA

Hello

 

Is it required to do the Leachable and Extractable test for container closure system of Ophthalmic product, targeting for ANDA filing? Please note that both RLD and generic have got the same Q1Q2 composition and also the same type of container closure system (LDPE container) .

Can anybody help me out on any guidance on this issue, please? 

 

Best Regards

 

Mir Motaher Hossain | Sr. Manager, Regulatory Affairs | Cell +88 01713336904  I

 

 

 

 

Disclaimer: This E-mail, including any attachments contains information which is confidential and/or privileged. If you are not the intended recipient, please notify us immediately and destroy this email without taking any copies or showing it to anyone. Unauthorized use of this e-mail is prohibited. SQUARE will not take any responsibility for misdirection, corruption or unauthorized use of e-mail communications, or for any damage that may be caused as a result of transmitting or receiving an e-mail communication.

Reference is made to the Q&A document that is for stability testing of drug substances and products. Page 13 Q5.

Can the Agency clarify expectations around the number of batches to support tests such as preservative effectiveness and extractable leachable testing?

One of the primary batches of the drug product should be tested for antimicrobial preservative effectiveness (in addition to preservative content) at the end of the proposed shelf life. The drug product specification should include a test for preservative content, and this attribute should be tested in all stability studies.  

Extraction/leachable studies are generally one-time studies; however, if multiple types of containers/closures are employed for packaging, then additional studies could be recommended.

Hope this helps but YES, all liquids require E/L testing as a one off testing.

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John Lay
Director, Regulatory and Quality
Vistapharm Inc.
Largo FL
United States

Original Message:
Sent: 10-25-2015 20:57
From: Janet DeLeon
Subject: Leachable and Extractable test for Ophthalmic ANDA

In my experience, the testing is not required when the formulation is known to be Q1/Q2 and the same container closure resin is used.  FDA has approved ANDAs without the testing.

------------------------------
Janet DeLeon
CEO
DeLeon Pharmaceutical Consulting, LLC
Leawood KS
United States