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input out ratio of pharmaceutical product

Guest

What is the procedure to freeze input out put ratio of pharmaceutical products ???

 What documents require by the central excise???

regards

sonu parsad

 

Input-output ratio procedure requires standard formulation basis and supporting FDA approval plus batch records for excise submission. Freezing the input-output ratio for Central Excise requires using the company's standard formulation as the base and supporting the submitted ratio with regulatory product permission from the FDA and the Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) demonstrating actual input and output. (AI Summary)
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Achyut Kale on Sep 16, 2012

Dear Sonu,

The base for preparing the inpu-out ratio of pharmaceutical product is standard formulation designed by the company.

 

While submitting Input-output ratio to Central Excise it may be supported with FDA additional product permission as well as copy of BMR/BPR (batch manufactring Record/Batch packing record).

Regards

A D Kale

Guest on Sep 17, 2012

thanks for your valuable reply.

 

can you send the general procedure of freeze input out put ratio of pharmaceutical products.??

 

thnks for your support.

 

regards,

Sonu Parsad

 

Guest on Sep 20, 2012

 

Dear A D Kale

 

Can you advise me that for freezing input out ratio the batch size of the product will be of 100000 only

 

Looking forward to your kind advise

 

regards,

sonu Parsad

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